[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-chronic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,64,88,110,142,166,190,206,232,257,284,305,331,351,380,405,429,450,472,494,514,536,559],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100641486","phase-2-study-of-ahb-137-in-chronic-hepatitis-b-chb-participants-in-north-america-and-europe-regions-100641486",false,"NCT07654283","Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions","A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B in the North America and Europe Regions","ASPIRE-202","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Adults ≥18 years of age and up to 65 years of age (inclusive) at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.\n2. Body mass index (BMI) ≤35 kg\u002Fm².\n3. Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.\n4. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.\n5. HBV DNA meeting protocol-specified virologic criteria at Screening.\n6. Hepatitis B surface antigen (HBsAg) level meeting protocol-specified virologic criteria at Screening.\n7. Alanine aminotransferase (ALT) meeting protocol-specified criteria at Screening.\n8. Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.\n9. Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose.\n10. Males and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137.\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if any of the following criteria apply:\n\n1. Clinically significant disease other than chronic hepatitis B virus (HBV) infection.\n2. Concomitant clinically significant liver disease.\n3. Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.\n4. History of immune thrombocytopenia.\n5. Current suspected liver cirrhosis and\u002For evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screening is acceptable.\n6. History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.\n7. Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng\u002FmL at Screening.\n8. History of extrahepatic diseases potentially associated with HBV infection.\n9. Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible.\n10. Protocol-specified abnormal laboratory values at Screening.\n11. History of vasculitis or presence of signs or symptoms suggestive of vasculitis, or history or presence of diseases associated with vasculitis.\n12. History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded.\n13. History of hypersensitivity or allergy to any component of the investigational product (IP).\n14. Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor.\n15. Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant compliance.\n16. Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and\u002For in vitro fertilization during the study.\n17. Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within:\n\n    1. Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or\n    2. Six months, if neither half-life nor duration of effect is known\n18. Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies.\n19. Any of the following prior or concomitant therapies:\n\n    1. Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2 weeks) or topical\u002Finhaled corticosteroids\n    2. Interferon therapy within 12 months prior to first dose\n    3. Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster\n    4. Current treatment with bulevirtide\n20. Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin.\n21. Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.","ALL","18 Years","65 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).",[28],"Hepatitis B, Chronic",[30,31,32,33,28,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"Hepatitis","Chronic Hepatitis","Chronic Hepatitis B","Hepatitis B","Hepatitis B Virus","hepatitis B virus e-antigen","AHB-137","Nucleos(t)ide analogue","Nucleos(t)ide analog","Antisense Oligonucleotide","Blood-Borne Infections","Communicable Diseases","Infections","DNA Virus Infections","Virus Diseases","Hepatitis, Viral, Human","Liver Diseases","Digestive System Diseases","Chronic Disease","Disease Attributes","Pathologic Processes","Pathological Conditions, Signs and Symptoms","NOT_YET_RECRUITING","2026-06-12",{"date":55,"type":56},"2026-06-17","ACTUAL",{"date":55,"type":22},{"date":59,"type":22},"2028-07-26",{"name":61,"class":62},"AusperBio Therapeutics Inc.","INDUSTRY",9,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100621406","phase-2-phase-2-study-of-ahb-137-in-hbeag-negative-chronic-hepatitis-b-chb-participants-in-asia-pacific-region-100621406","NCT07370207","Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region","A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)Ide Analogue-treated Participants With HBeAg Negative Chronic Hepatitis B in the Asia Pacific Region","ASPIRE-201","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.\n2. Body mass index (BMI) ≤35 kg\u002Fm².\n3. Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.\n4. Hepatitis B e antigen (HBeAg) negative at Screening.\n5. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.\n6. HBV DNA below the lower limit of quantification (LLOQ) at Screening.\n7. Hepatitis B surface antigen (HBsAg) level \\>100 IU\u002FmL and ≤3,000 IU\u002FmL at Screening.\n8. Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) at Screening.\n9. Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.\n10. Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose.\n11. Male and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137.\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if any of the following criteria apply:\n\n1. Clinically significant disease other than chronic hepatitis B virus (HBV) infection, as documented in medical history or identified on physical examination, including but not limited to acute coronary syndrome within 6 months prior to Screening, significant or unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, or prior solid organ or bone marrow transplant\n2. Concomitant clinically significant liver disease, including but not limited to viral hepatitis caused by other pathogens, hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, drug-induced liver injury, or current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, hepatorenal syndrome, or variceal hemorrhage).\n3. Any severe infection (other than chronic HBV infection) within 1 month prior to randomization and\u002For requiring intravenous anti-infective therapy.\n4. History of immune thrombocytopenia.\n5. Current suspected liver cirrhosis and\u002For evidence of cirrhosis defined as liver stiffness measurement (LSM) \\>9 kPa by FibroScan® or equivalent imaging modality (e.g., ultrasound elastography).\n6. History of liver cirrhosis defined by liver biopsy or by LSM \\>12 kPa by FibroScan® or equivalent imaging modality.\n7. Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng\u002FmL at Screening.\n8. History of extrahepatic diseases potentially associated with HBV infection, including but not limited to nephrotic syndrome, any form of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, or uncontrolled hypertension.\n9. Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible.\n10. Abnormal laboratory values at Screening meeting any of the following criteria:\n\n    1. Serum albumin \\\u003C3.5 g\u002FdL\n    2. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² calculated using the CKD-EPI equation (or JSN-CKDI equation for participants in Japan)\n    3. International normalized ratio (INR) \\>1.25\n    4. Platelet count \\\u003C125 × 10⁹\u002FL\n    5. Total bilirubin \\>1.5 × upper limit of normal (ULN). Participants with benign unconjugated hyperbilirubinemia (Gilbert's syndrome) may be enrolled if deemed eligible by the Investigator\n    6. Urine albumin-to-creatinine ratio (uACR) \\>0.3 mg\u002Fmg (300 mg\u002Fg) on two consecutive measurements following a positive or weakly positive urine protein result on routine urinalysis\n    7. Borderline positive or positive antineutrophil cytoplasmic antibody (ANCA) results requiring further evaluation (MPO-ANCA and PR3-ANCA). Eligibility requires review of complete medical history and confirmation of no past or current vasculitic, inflammatory, or autoimmune disease by the Sponsor or Sponsor-designated Medical Monitor\n11. History of vasculitis or presence of signs or symptoms suggestive of vasculitis (e.g., vasculitic rash, skin ulceration, unexplained recurrent hematuria), or history or presence of diseases associated with vasculitis (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).\n12. History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded.\n13. History of hypersensitivity or allergy to any component of the investigational product (IP).\n14. Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor.\n15. Current alcohol or substance abuse that, in the Investigator's judgment, may interfere with study participation or compliance.\n16. Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and\u002For in vitro fertilization during the study.\n17. Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within:\n\n    1. Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or\n    2. Six months, if neither half-life nor duration of effect is known\n18. Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies.\n19. Any of the following prior or concomitant therapies:\n\n    1. Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2 weeks) or topical\u002Finhaled corticosteroids\n    2. Interferon therapy within 12 months prior to first dose\n    3. Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster\n    4. Current treatment with bulevirtide\n20. Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin, unless the Investigator determines the medication can be safely discontinued prior to first IP administration. Participants taking low-dose aspirin must agree to discontinue use during the study if protocol-specified conditions are met.\n21. Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.",{"count":73,"type":22},84,[25],"This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).",[28],[30,31,32,33,28,34,35,36,38,37,39,40,41,42,43,44,45,46,47,48,49,50,51],"RECRUITING","2026-05-28",{"date":81,"type":56},"2026-06-01",{"date":83,"type":56},"2026-03-06",{"date":85,"type":22},"2028-12-31",{"name":61,"class":62},8,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100640828","phase-1-study-of-ahb-171-in-chronic-hepatitis-b-participants-100640828","NCT07617194","Study of AHB-171 in Chronic Hepatitis B Participants","A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171","EXTEND-101","Inclusion Criteria:\n\n* Male or female participants, aged 18-65 years old (inclusive)\n* Body Mass Index between 19 to 35 kg\u002Fm2 (inclusive)\n* Body weight \\> or = 45 kg.\n* Documented HBV infection for ≥6 months prior to randomization.\n* For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.\n* For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.\n* Screening electrocardiogram (ECG) without clinically significant abnormalities\n* Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine\u002Fserum pregnancy test before dosing (unless permanently sterile or \\>2 years postmenopausal).\n* Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.\n* Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.\n\nExclusion Criteria:\n\n* Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).\n* Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).\n* History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).\n* Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng\u002FmL.\n* HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).\n* Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.\n* Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).\n* Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).\n* History or signs of vasculitis or related autoimmune diseases.\n* Malignancy within 5 years (except non-melanoma skin cancer).\n* Allergy to study drug components.\n* Recent major surgery\u002Ftrauma (within 3 months) or planned surgery during study.\n* Alcohol or substance abuse affecting compliance.\n* Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.\n* Participation in another clinical trial or recent investigational product use.\n* Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.\n* Recent or ongoing use of immunosuppressive\u002Fbiologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.\n* Need for long-term anticoagulants\u002Fantiplatelet drugs (unless safely stopped).\n* Any other condition making the participant unsuitable (per investigator).",{"count":97,"type":22},144,[99],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts\u002Fcohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.",[28],"2026-05-24",{"date":81,"type":56},{"date":105,"type":22},"2026-07-06",{"date":107,"type":22},"2028-08-14",{"name":61,"class":62},2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":141},"100635521","early-phase-1-efficacy-and-safety-of-pegylated-interferon-alpha-2-in-patients-with-hepatitis-b-related-hepatocellular-carcinoma-after-radical-resection-100635521","NCT07553767","Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection","A Non-randomized Controlled, Prospective, Real-world Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection","Inclusion Criteria:\n\n* Age 18 to 65 years, male or female.\n* Confirmed diagnosis of hepatitis B virus-related hepatocellular carcinoma (HCC) by pathology or contrast-enhanced CT\u002FMRI.\n* Underwent radical resection or local ablation therapy; CNLC (Chinese Liver Cancer Classification) stage Ia, Ib, or IIa; no residual tumor confirmed by imaging within 1-3 months postoperation.\n* HBsAg positive and HBsAg level \\\u003C 2000 IU\u002FmL.\n* No prior systemic chemotherapy, immunotherapy, or targeted therapy before enrollment.\n* Able to provide written informed consent and comply with the follow-up schedule.\n* For women of childbearing potential: negative pregnancy test and effective contraception during treatment and for 24 weeks after the last dose.\n\nExclusion Criteria:\n\n* Recurrent or metastatic HCC at enrollment.\n* Contraindication to peginterferon alfa-2b treatment.\n* WBC \\\u003C 3.5×10⁹\u002FL or platelet count \\\u003C 100×10⁹\u002FL.\n* ALT \\> 3×ULN or total bilirubin (TBIL) \\> 2×ULN.\n* Child-Pugh score \\> 5 points.\n* INR \\> 1.5.\n* History of organ transplantation or planned transplantation.\n* Hypersensitivity to peginterferon alfa-2b or any excipient of the study drug.\n* Pregnant or breastfeeding women.\n* Participation in another interventional clinical trial.\n* History of significant alcoholism or drug abuse.\n* Genetic or metabolic liver disease (Wilson disease, hemochromatosis, etc.).\n* Coinfection with HAV, HCV, HEV, EBV, CMV , or other viral hepatitis that may interfere with study evaluation.\n* Unable to comply with study procedures and follow-up.\n* Other conditions deemed inappropriate by the investigator.",{"count":118,"type":22},156,[120],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the efficacy and safety of peginterferon alfa-2β (Peg-IFN-α-2β) combined with nucleos(t)ide analogues (NAs) in patients aged 18 to 65 years with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical resection. The main questions it aims to answer are:\n\n* What are the changes in hepatitis B surface antigen (HBsAg) disappearance rate, HBsAg seroconversion rate, HBsAg decline, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels during treatment and at the end of treatment?\n* What are the 1-year, 2-year, 3-year, and 5-year recurrence-free survival (RFS) and overall survival (OS) of the included patients?\n* What are the correlations between changes in HBsAg, T helper 1\u002FT helper 2 (Th1\u002FTh2) subsets, intestinal flora and RFS, OS in these patients?\n\nResearchers will compare Peg-IFN-α-2β combined with NAs to NAs alone to see if the combination treatment can improve HBsAg clearance, seroconversion, long-term survival and reduce recurrence in patients after radical resection of hepatitis B-related hepatocellular carcinoma.\n\nParticipants will:\n\n* Receive either Peg-IFN-α-2β combined with first-line NAs (tenofovir disoproxil fumarate \\[TDF\\], tenofovir alafenamide fumarate \\[TAF\\], tenofovir amibufen fumarate \\[TMF\\]) or first-line NAs alone\n* Undergo regular assessments including HBsAg, HBV DNA, liver and renal function, blood routine, thyroid function, autoantibodies, and tumor markers\n* Provide stool samples for intestinal flora analysis at specified time points\n* Complete long-term survival follow-up for up to 5 years",[123,124,125],"Hepatocellular Carcinoma","HEPATITIS B CHRONIC","Hepatitis B Chronic Infection",[127,128,129,130],"Peg-IFN-α-2b","hepatitis B","hepatocellular carcinoma","prognosis","2026-04-20",{"date":133,"type":56},"2026-04-28",{"date":135,"type":22},"2026-03-31",{"date":137,"type":22},"2035-12-31",{"name":139,"class":140},"Ningbo No.2 Hospital","OTHER",4,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100634779","effect-of-babao-dan-capsule-combined-with-antiviral-therapy-on-the-incidence-of-hepatocellular-carcinoma-in-patients-with-hepatitis-b-related-cirrhosis-100634779","NCT07544121","Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis","Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form\n2. Aged 18-65 years\n3. Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun\n4. Meeting the diagnostic criteria for hepatitis B-related cirrhosis\n5. aMAP score \\> 60\n\nExclusion Criteria:\n\n1. Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies\n2. Pregnant or lactating women\n3. Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)\n4. Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury\n5. Severe cardiac, renal, respiratory, or hematopoietic system diseases\n6. Determined by the investigator to be unsuitable for participation in this trial",{"count":150,"type":22},1034,[152],"NA","This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score \\>60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.",[124,155,156],"Cirrhosis, Liver","Hepatocellular Carcinoma (HCC)","2026-04-19",{"date":159,"type":56},"2026-04-22",{"date":161,"type":22},"2026-04-01",{"date":163,"type":22},"2028-11-30",{"name":165,"class":140},"Nanfang Hospital, Southern Medical University",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":173,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":109},"100630759","oral-periodontal-evaluation-and-assessment-of-oral-fluid-biomarkers-in-patients-with-hepatitis-bd-100630759","NCT07491848","Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D","Oral-Periodontal Evaluation and Assessment of Biomarkers in Oral Fluids in Patients With Hepatitis B+D Treated With Bulevirtide","Inclusion Criteria:\n\n* Adults (≥18 years old) capable of providing informed consent.\n* For Hepatitis B+D groups: confirmed hepatitis B and D co-infection.\n* Bulevirtide group: receiving bulevirtide therapy as prescribed.\n* No Bulevirtide group: not receiving bulevirtide.\n* For Healthy Control group: systemically healthy adults without hepatitis B or D infection.\n* Willingness to undergo oral-periodontal examination, saliva and gingival crevicular fluid collection, and oral cavity photography.\n\nExclusion Criteria:\n\n* Patients with other systemic diseases that could influence periodontal health (e.g., uncontrolled diabetes, autoimmune diseases).\n* Patients currently receiving other experimental therapies that may affect oral or systemic inflammation.\n* Pregnancy or lactation.\n* Inability or unwillingness to provide informed consent.\n* History of oral or periodontal surgery within the last 6 months that could affect measurements.",true,{"count":175,"type":22},25,"OBSERVATIONAL","Periodontal disease is a chronic inflammatory condition associated with systemic diseases, highlighting the concept of periodontal medicine. This study aims to investigate the relationship between periodontal inflammation, oral lesions, and hepatitis B+D infection, with or without bulevirtide treatment. Oral-periodontal clinical parameters and targeted inflammatory biomarkers in saliva and gingival crevicular fluid will be evaluated in three groups: patients with hepatitis B+D receiving bulevirtide, patients with hepatitis B+D not receiving bulevirtide, and healthy controls.",[124,179,180],"Hepatitis D","Periodontitis","2026-03-19",{"date":183,"type":56},"2026-03-25",{"date":185,"type":56},"2026-02-15",{"date":187,"type":22},"2027-02-15",{"name":189,"class":140},"Research Center of Periodontal-Systemic Interactions",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":204,"leadSponsor":205,"locationsCount":4},"100629927","effect-of-fufang-biejiaruangan-combined-with-antiviral-therapy-on-the-incidence-of-hepatocellular-carcinoma-in-patients-with-hepatitis-b-related-cirrhosis-a-multicenter-randomized-placebo-controlled-study-100629927","NCT07481032","Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study","Inclusion Criteria:\n\n* Voluntarily signed informed consent form\n* Aged 18-65 years\n* Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu\n* Meeting the diagnostic criteria for hepatitis B-related cirrhosis\n* aMAP score \\> 60\n\nExclusion Criteria:\n\n* \\[Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies\n* Pregnant or lactating women\n* Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)\n* Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury\n* Severe cardiac, renal, respiratory, or hematopoietic system diseases\n* Determined by the investigator to be unsuitable for participation in this trial",{"count":150,"type":22},[152],"This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue\\_yu syndrome and have an aMAP score \\>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.",[155,156,124],"2026-03-15",{"date":202,"type":56},"2026-03-18",{"date":161,"type":22},{"date":163,"type":22},{"name":165,"class":140},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":216,"conditions":217,"keywords":218,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100628268","entecavir-resistance-associated-mutations-in-chronic-hbv-patients-in-turkey-stream-study-100628268","NCT07459426","Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)","Sequencing-Based Tracking of Entecavir Resistance-Associated Mutations in Chronic Hepatitis B Patients: A Multicenter Observational Study (STREAM)","Inclusion Criteria:\n\n* Age ≥18 years\n* HBsAg positive\n* Group 1: Either treatment-naïve participants with HBV DNA\\>2000 IU\u002Fml\n* Group 2: Prior lamivudine therapy ≥6 months with switch to ADVor TDF or TAF\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Prior entecavir exposure\n* Prior telbivudine exposure\n* Age \\\u003C18 years\n* Inability to provide informed consent Note: Previous adefovir or (pegylated) interferon use is not an exclusion criterion.\n\nPatients with insufficient sample volume or inadequate DNA quality for sequencing will be excluded from final analysis.","80 Years",{"count":215,"type":22},700,"Chronic hepatitis B is a long-term viral infection that affects millions of people worldwide. Patients usually require lifelong antiviral treatment to control the virus and prevent liver damage.\n\nSome older antiviral medications, such as lamivudine, can lead to the development of viral resistance. This means the virus changes in a way that makes certain treatments less effective. Even though newer drugs like entecavir are stronger and more resistant to these changes, previous exposure to lamivudine may increase the risk of developing additional resistance mutations.\n\nBy analyzing viral genetic material from blood samples using advanced sequencing technology, this research will help improve understanding of antiviral resistance patterns in patients with chronic hepatitis B in Turkey and may support better treatment decisions in the future.",[28],[219,220,221,222],"Chronic hepatitis B","Lamivudine","Entecavir","Antiviral resistance","2026-03-05",{"date":225,"type":56},"2026-03-09",{"date":200,"type":22},{"date":228,"type":22},"2027-03-15",{"name":230,"class":140},"Yaşar Bayındır, MD",1,{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100611578","comparison-of-a-handheld-elastography-device-with-ilivtouch-in-chronic-liver-disease-patients-100611578","NCT07242404","Comparison of a Handheld Elastography Device With iLivTouch in Chronic Liver Disease Patients","Evaluation of Agreement Between the Handheld Elastography Device and iLivTouch for Multi-Position Liver Assessment in Chronic Liver Disease","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed with one of the following:\n\n  * Chronic hepatitis B or compensated HBV-related cirrhosis (based on the 2022 Chinese CHB guidelines), or\n  * Metabolic dysfunction-associated fatty liver disease (MAFLD), metabolic dysfunction-associated steatohepatitis (MASH), or fibrosis\u002Fcirrhosis due to MAFLD (based on the 2024 MAFLD guidelines).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Chronic liver disease due to other etiologies (e.g., other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic\u002Fmetabolic liver disease).\n* Evidence of decompensated cirrhosis.\n* Total bilirubin \\> 51 μmol\u002FL.\n* ALT \\> 5 × upper normal limit.\n* Presence of hepatocellular carcinoma, hepatic hemangioma, large hepatic cyst, or other space-occupying liver lesions.\n* Co-infection with HIV.\n* History of liver transplantation or TIPS.\n* Pregnancy.\n* Congestive hepatopathy.\n* Unhealed wounds in the right upper abdomen.\n* Inability to maintain the required sitting position.",{"count":240,"type":22},224,"This single-center cross-sectional study aims to evaluate the agreement between a handheld elastography device and the iLivTouch transient elastography system for the noninvasive assessment of liver fibrosis and steatosis in adults with chronic liver disease. The study compares liver stiffness measurement (LSM) and ultrasound attenuation parameter (UAP) obtained by both devices in the standard supine position, and further explores the feasibility and consistency of measurements performed in the sitting position.\n\nAll participants will undergo paired examinations using both devices in two body positions (supine and sitting). Agreement between devices and between body positions will be assessed using Bland-Altman analysis, intraclass correlation coefficients, and categorical consistency metrics. The study will also evaluate device performance indicators, including measurement success rate, procedure time, and battery endurance under simulated clinical conditions.\n\nThis study aims to provide clinical evidence on the accuracy, reliability, and feasibility of a new handheld transient elastography device, and to explore whether sitting-position measurements can serve as an alternative to standard supine assessment in chronic liver disease patients.",[243,124],"MAFLD",[245,246,247],"Transient Elastography","Noninvasive Liver Assessment","Agreement Study","2025-11-17",{"date":250,"type":56},"2025-11-21",{"date":252,"type":22},"2025-12-01",{"date":254,"type":22},"2026-05-31",{"name":256,"class":140},"Hong You",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":141},"100568362","phase-1-phase-1-study-to-evaluate-safety-and-antiviral-activity-of-pbgene-hbv-in-adult-patients-with-chronic-hepatitis-b-100568362","NCT06680232","Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B","A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)","ELIMINATE-B","Key Inclusion Criteria:\n\n* Male or women of non-child bearing potential\n* BMI 18.0 to 35.0\n* Good overall health deemed by the study Investigator\n* CHB infection documented at least 12 months prior to screening\n* HBeAg-negative CHB\n* Must be virologically suppressed on current NA treatment\n\nKey Exclusion Criteria:\n\n* No history of cirrhosis of the liver\n* No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.\n* No signs of hepatocellular carcinoma\n* Not received an organ transplant\n* No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)\n* No investigational agent received within 6 months of screening","70 Years",{"count":267,"type":22},45,[99],"This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.",[124],[124,272,273,274],"Gene Therapy","Gene Editing","PBGENE-HBV","2025-09-22",{"date":277,"type":56},"2025-09-26",{"date":279,"type":56},"2024-11-14",{"date":281,"type":22},"2026-12",{"name":283,"class":62},"Precision BioSciences, Inc.",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":231},"100532719","phase-2-vaccinal-effect-of-hbsag-monoclonal-ab-vir-3434-in-chronic-hepatitis-b-infection-vision-100532719","NCT06216470","Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]","Phase II Investigator-Initiated Study to Understand the Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection","Inclusion Criteria:\n\n1. Age ≥ 18 to ≤65 years\n2. Chronic HBV infection with evidence of HBsAg-positivity x \\> 6 months\n3. Quantitative HBsAg 300 - 10,000 IU\u002FmL\n4. On stable nucleos(t)ide therapy \\>1 year\n5. HBV DNA \\\u003C 60 IU\u002FmL on 2 occasions at least 12 weeks apart\n6. ALT ≤ 45 U\u002FL on 2 occasions at least 12 weeks apart\n7. Female subjects must have a negative pregnancy test or confirmation of postmenopausal status. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of contraception 14 days before study drug administration through the study participation. Female subjects must also agree to refrain from egg donation and in vitro fertilization from the time of study drug administration through the study participation.\n8. Male subjects with female partners of child-bearing potential must agree to meet 1 of the following contraception requirements from the time of study drug administration through the study participation: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP. Male subjects must also agree to not donate sperm from the time of study drug administration through the study participation.\n9. Able and willing to sign informed consent\n\nExclusion Criteria:\n\n1. History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) \\> 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence of decompensation (ascites, hepatic encephalopathy)\n2. History of or current hepatocellular carcinoma\n3. Hepatitis C Virus (HCV) RNA or anti-Hepatitis D Virus (HDV) positive\n4. HIV co-infection\n5. Pregnancy or lactation\n6. Alanine Aminotransferase (ALT) \\> 45 U\u002FL\n7. History of chronic liver disease other than HBV aside from fatty liver documented only on US\n8. Use of peginterferon therapy for HBV infection within past 12 months\n9. Use of chronic immunosuppressive medications at a dose equivalent to 10 mg daily of prednisone or greater within past 6 months\n10. Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in previous 6 months, malignancy other than non-melanoma skin cancer in previous 5 years, immunodeficiency syndrome\n11. Subject has received any investigational drug (including any investigational vaccines) within 90 days or 5 half-lives (whatever is longer) before screening for this study or is currently enrolled in an investigational study\n12. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments, such as liver FNAs\n13. Platelet count \\\u003C 120,000,000,000\u002FL\n14. The International Normalised Ratio (INR) \\> 1.3\n15. Bilirubin \\> 40 µmol\u002FL\n16. Hemoglobin \\\u003C 110 g\u002FdL for women or 120 g\u002FdL for men\n17. estimated Glomerular Filtration Rate (eGFR) \\\u003C 45 cc\u002Fmin\n18. Alpha Fetoprotein (AFP) \\> 50 ng\u002FmL\n19. Prior liver or other solid organ transplantation\n20. Patients on anticoagulation therapy or with any bleeding diathesis\n21. Patients with hemoglobinopathy (thalassemia, sickle cell disease etc)\n22. Other significant liver disease: alcoholic liver disease, autoimmune hepatitis, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson Disease or alpha-1 antitrypsin deficiency - as documented in clinical history\n23. Unable to provide informed consent",{"count":292,"type":22},15,[25],"This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection.\n\nThe purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body.\n\nThis is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.",[28],"2025-05-27",{"date":298,"type":56},"2025-05-29",{"date":300,"type":56},"2024-03-13",{"date":302,"type":22},"2029-12",{"name":304,"class":140},"University Health Network, Toronto",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":231},"100453278","phase-4-peginterferon-treatment-study-for-inactive-chronic-hepatitis-b-patients-100453278","NCT05182463","Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients","Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study","Inclusion Criteria:\n\n* Age 18-60, no gender limitation\n* HBsAg is positive for more than 6 months\n* Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive\n* Serum HBV DNA is less than 2000 IU\u002FmL\n* Alanine aminotransferase(ALT) and\u002For Aspartate aminotransferase(AST) is normal\n* No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment\n* Good compliance and voluntarily signed informed consent\n\nExclusion Criteria:\n\n* Allergic to pegylated interferon α-2b\n* Any indication of liver cirrhosis\n* Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV)\n* Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.)\n* There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus\n* Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism)\n* Confirmed or suspected liver cancer or other malignant tumors\n* Patients after or preparing for organ transplantation\n* Peripheral blood white blood cell count \\\u003C 3.5×109\u002FL and\u002For platelet count \\\u003C 80×109\u002FL\n* Under immunosuppressant treatment\n* Pregnant or planned pregnancy in a short term or lactation patients\n* Alcohol abuse (average alcohol intake is more than 40 g\u002Fd in males or 20g\u002Fd in women) or drug addicts\n* Present or past history of mental or psychological diseases\n* Other conditions that the investigators deem inappropriate for the study.","60 Years",{"count":314,"type":22},5000,[316],"PHASE4","There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients.\n\nIn recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB.\n\nThe purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.",[28],[320,321],"inactive chronic hepatitis B","functional cure","2025-04-28",{"date":324,"type":56},"2025-05-01",{"date":326,"type":56},"2022-01-08",{"date":328,"type":22},"2029-11-30",{"name":330,"class":140},"Third Affiliated Hospital, Sun Yat-Sen University",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":231},"100587045","sequential-peg-ifn-for-hbv-after-ending-rna-targeted-regimens-100587045","NCT06923280","Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens","Efficacy and Safety of Pegylated Interferon Therapy in Chronic Hepatitis B Patients After Discontinuation of Antisense Oligonucleotide or Small Interfering RNA: A Prospective, Adaptive, Open-label, Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years.\n* Chronic HBV infection (documented HBsAg positivity for \\>6 months).\n* Prior participation in ASO or siRNA clinical trials:\n* Received ≥1 dose of ASO\u002FsiRNA (or matched placebo, if applicable).\n* Achieved ≥1 log10 IU\u002FmL HBsAg decline from baseline during prior therapy.\n* Discontinued ASO\u002FsiRNA therapy before screening.\n* Screening HBsAg: 0.05-500 IU\u002FmL.\n* No prior interferon (IFN) therapy within 6 months before enrollment.\n* Willingness to comply with study-related treatments, tests, and procedures.\n* Commitment to contraception during the study.\n* Voluntary participation with signed informed consent.\n\nExclusion Criteria:\n\n* Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before\u002Fduring screening).\n* Elevated AFP: Screening AFP \\>100 ng\u002FmL; AFP 20-100 ng\u002FmL with imaging-confirmed hepatocellular carcinoma (ultrasound\u002FCT\u002FMRI).\n* Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV).\n* Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for \\>2 weeks within 6 months before enrollment.\n* Pregnancy, lactation, or plans for pregnancy during the study.\n* Autoimmune hepatitis.\n* Active autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus).\n* Uncontrolled cardiovascular disease (e.g., unstable angina, myocardial infarction within 6 months).\n* Poorly controlled endocrine disorders (e.g., diabetes mellitus, thyroid dysfunction).\n* Severe psychiatric disorders: History of depression, anxiety, bipolar disorder, schizophrenia, or family history of psychiatric conditions (especially depression).\n* Substance abuse: Alcohol (\\>40 g\u002Fday for males; \\>20 g\u002Fday for females) or Illicit drug use.\n* Severe retinopathy or ophthalmologic disorders.\n* Renal diseases: Chronic nephritis, renal insufficiency, nephrotic syndrome.\n* Major organ dysfunction (e.g., heart, lung, pancreas).\n* Organ transplant recipients or candidates.\n* Hypersensitivity to interferon or excipients.\n* Concurrent participation in other HBV-related interventional trials.\n* Other conditions deemed unsuitable by investigators (e.g., non-compliance risk).",{"count":339,"type":22},30,[152],"The goal of this clinical trial is to compare sequential PEG-IFNα therapy strategies in chronic hepatitis B (CHB) patients previously treated with ASO\u002FsiRNA. The main questions it aims to answer are:\n\n1. Does sequential PEG-IFNα therapy (vs. deferred\u002Fno treatment) improve HBsAg clearance rates?\n2. What are the HBsAg clearance and relapse rates after 24 weeks of PEG-IFNα therapy?\n3. Is intermittent PEG-IFNα therapy as effective and safe as continuous therapy?\n\nResearchers will compare:\n\n• Group A (immediate 24-week PEG-IFNα + 24-week follow-up) vs. Group B (24-week observation + 24-week PEG-IFNα) in Phase 1 to see if sequential PEG-IFNα therapy will improve HBsAg loss rate .\n\nResearchers will describe:\n\n* The response rate of IFN treatment in non-responders (HBsAg-positive) in Phase 2.\n* The relaspe rate of responders (HBsAg-negative).\n\nParticipants will:\n\nPhase 1 (0-48 weeks):\n\n* Group A: Receive PEG-IFNα for 24 weeks, followed by 24-week treatment-free follow-up.\n* Group B: Undergo 24-week observation, then receive PEG-IFNα for 24 weeks.\n\nPhase 2 (48-96 weeks):\n\n* HBsAg-positive at week 48 patients either from group A or group B : Receive 24-week PEG-IFNα therapy, followed by 24-week follow-up.\n* HBsAg-negative at week 48 patients either from group A or group B: Enter 24-week follow-up without treatment.\n\nAll participants will undergo:\n\n• HBsAg quantification, HBV DNA, liver function, and safety monitoring (every 12 weeks).",[28],"2025-04-09",{"date":345,"type":56},"2025-04-11",{"date":324,"type":22},{"date":348,"type":22},"2028-05-31",{"name":350,"class":140},"Huashan Hospital",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":360,"studyType":176,"phases":4,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":379},"100375268","national-cohort-of-patients-co-infected-with-hepatitis-b-and-delta-viruses-100375268","NCT04166266","National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses","HEPDELTA","Inclusion Criteria:\n\n* Age \\> 18 years,\n* Presenting a chronic HDV infection (positive serology),\n* Who gave his written informed consent before any intervention and the day of inclusion at the latest,\n* Affiliated to Health Insurance or to the \"Aide Médicale d'Etat\" (request for exemption pending).\n\nExclusion Criteria:\n\n* Patient participating in another biomedical research with an exclusion period ongoing at inclusion,\n* Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).\n* Patients with predictable difficulties of follow-up according to the investigator.",{"count":359,"type":22},800,"7 Years","This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV\u002FHDV co-infection.",[363,28],"Hepatitis D, Chronic",[365,366,367,368],"safety","efficacy","evolution","treatment","2025-02-03",{"date":371,"type":56},"2025-02-05",{"date":373,"type":56},"2020-02-19",{"date":375,"type":22},"2028-06-30",{"name":377,"class":378},"ANRS, Emerging Infectious Diseases","OTHER_GOV",38,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":387,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":231},"100408337","combination-of-dpmas-and-low-volume-pe-for-patients-with-hbv-related-aclf-100408337","NCT04597164","Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF","Double Plasma Molecular Adsorption System With Sequential Low-Dose Plasma Exchange in Patients With Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \\> 0.5 year);\n2. Age from 18 to 65 years old;\n3. Clinical diagnosis of liver failure (serum total bilirubin level \\> 10 times upper limit of normal; prothrombin time activity \\\u003C 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and \\> 1.5);\n4. Platelets \\> 50\\*10 E9\u002FL.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Hepatocellular carcinoma or other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events;\n6. Other important organ dysfunctions or transplantation;\n7. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate.",{"count":388,"type":22},200,"This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.",[28,391],"Acute-On-Chronic Liver Failure",[393,394,395,396],"hepatitis b virus","acute-on-chronic liver failure","double plasma molecular adsorption system","plasma exchange","2024-11-26",{"date":399,"type":56},"2024-11-29",{"date":401,"type":56},"2020-12-22",{"date":403,"type":22},"2024-12-31",{"name":330,"class":140},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":412,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":231},"100558400","improved-sensitivity-detection-of-serum-hbsag-and-hbsag-reversion-100558400","NCT06550622","Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion","Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion","Inclusion Criteria:\n\n* HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative;\n* Having serum specimens retained at baseline and at 48 weeks off treatment follow up;\n* Being willing to follow up regularly for 1 year.\n\nExclusion Criteria:\n\n* Patients with hepatitis B cirrhosis in the compensated and decompensated stages: this includes patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 prior to NUC treatment, or who have had complications of the decompensated stage of cirrhosis, such as ascites, hepatic encephalopathy, or ruptured oesophago-gastric fundal varices bleeding;\n* Combined HAV, HCV, HDV, HEV, HIV infections, alcoholic liver disease, inherited metabolic liver disease, pharmacological liver disease, non-alcoholic fatty liver disease, autoimmune liver disease and other chronic liver diseases;\n* Primary hepatocellular carcinoma or those with AFP greater than 100 ng\u002Fml at screening and imaging suggestive of possible malignant hepatic occupancy; or patients with AFP greater than 100 ng\u002Fml for a sustained period of 3 months;\n* Patients with a combination of other malignant tumours (excluding those who have been cured);\n* Patients with severe diseases or uncontrolled disease\n* Those who are also participating in other clinical studies;\n* Patients deemed unsuitable by the investigator to participate in this study.",{"count":413,"type":22},300,"The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay.\n\nThe main question it aims to answer is:\n\nWhat's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU\u002Fml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU\u002Fml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.",[28],[417,418,419,420],"HBsAg next assay","Functional cure","HBsAg loss","HBsAg reversion","2024-08-08",{"date":423,"type":56},"2024-08-13",{"date":425,"type":22},"2024-08-10",{"date":427,"type":22},"2027-08-10",{"name":350,"class":140},{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":173,"sex":17,"minAge":18,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":449},"100556500","a-real-world-study-of-staging-and-grading-of-clinical-immune-status-in-chronic-hepatitis-b-100556500","NCT06525909","A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B","Inclusion Criteria:\n\n1. Patients with CHB who were older than 18 years old and younger than 50 years old with HBsAg positivity more than 6 months;\n2. Group 1 untreated group fulfils any one of the four natural history types of the Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022.\n3. Group 2 nucleos(t)ide-treated CHB patients are required to have sustained control of their HBV DNA (\\\u003C100 IU\u002Fml).\n\nExclusion Criteria:\n\n1. Pregnancy status;\n2. Has been diagnosed with compensated\u002Flost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators;\n3. Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection;\n4. Being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc;\n5. previous history of oncology, organ transplantation, etc., history of alcoholism (\\>30 g\u002Fd for men, \\>20 g\u002Fd for women);\n6. Inadequate follow-up time and inadequate clinical\u002Flaboratory information;\n7. Combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases;\n8. Comorbid serious psychiatric diseases including severe anxiety or depression;\n9. Unwilling to participate in this study.","50 Years",{"count":437,"type":22},250,"This is a prospective, multicentre observational study of Chronic Hepatitis B （CHB）in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with CHB.",[28],"2024-07-24",{"date":442,"type":56},"2024-07-29",{"date":444,"type":56},"2024-01-20",{"date":446,"type":22},"2028-12-10",{"name":448,"class":140},"Tongji Hospital",5,{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100550870","phase-1-a-clinical-study-to-evaluate-the-efficacy-of-tqa3038-injection-in-patients-with-chronic-hepatitis-b-100550870","NCT06452693","A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B","A Phase Ib\u002FIIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study and sign informed consent;\n* Male and female ≥18 years old and ≤65 years old;\n* Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18\\~28 kg\u002Fm2;\n* Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU\u002Fml ≤ HBsAg quantification ≤ 5000 IU\u002Fml;\n* The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;\n* The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures during the clinical trial period and long-term follow-up period, and specific contraceptive measures are shown in the appendix;\n* The treated patients need to meet the condition:The subject must have received oral nucleoside (acid) drug treatment and a stable treatment regimen;\n* Newly treated patients must meet the condition:During screening, the subjects had never received antiviral treatment for chronic hepatitis B B (oral nucleoside (acid) drugs and interferon), or had irregular antiviral treatment in the past, but had not received any antiviral treatment for chronic hepatitis B 3 months before enrollment.\n\nExclusion Criteria:\n\n* Pregnant and lactating women;\n* Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;\n* Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;\n* Individuals with a history of active pathological bleeding or a tendency towards bleeding;\n* Prescription medication has been used within 14 days prior to receiving the study drug;\n* Receive any preventive or attenuated vaccines within 14 days prior to receiving the study drug;\n* Blood donors or those who have lost a significant amount of blood within the first 3 months of screening, or those who have donated blood during the planned study period;\n* Subjects with a history of excessive alcohol consumption;\n* A history of alcohol or drug abuse within the 12 months prior to screening, or a positive drug screening result during screening;\n* Complicated with other infected disease;\n* Patients with significant liver fibrosis or cirrhosis before or during screening;\n* History of chronic liver diseases other than chronic HBV infection;\n* Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;\n* Used immunosuppressive or immunomodulatory drugs and cytotoxic drugs within 6 months prior to the study medication;\n* During screening, subjects showed significant laboratory results abnormalities；\n* Screening for tumors with a history of malignancy within the first 5 years, excluding tumors that can be completely cured through surgical resection;\n* Uncontrollable chronic diseases;\n* History of intolerance to subcutaneous injection;\n* Participated in clinical studies of any drug or medical device within 3 months prior to drug administration or within 5 times the half-life of the investigational drug, or used the investigational drug;\n* Those considered unsuitable for enrollment by the investigators.",{"count":458,"type":22},162,[99,25],"This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.",[28],"2024-06-06",{"date":464,"type":56},"2024-06-11",{"date":466,"type":22},"2024-06",{"date":468,"type":22},"2026-09",{"name":470,"class":62},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",22,{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":479,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":231},"100514345","hbsag-declined-patients-follow-up-study-100514345","NCT05977283","HBsAg Declined Patients Follow-up Study","An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months","Inclusion Criteria:\n\n* Participants must have HBsAg decline ≥0.5 log10 IU\u002FmL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU\u002FmL or actual values ≤3 log10 IU\u002FmL.\n* Able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonization (ICH) and local regulations.\n\nExclusion Criteria:\n\n* Any condition which, in the opinion of the investigator, contraindicates their participant in this study.\n* Participants who are currently participating in interventional clinical study exploring HBV treatment.",{"count":480,"type":22},100,"The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening. The main question it aims to answer are:\n\n\\- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason (with or without new molecular entities therapy).\n\nParticipants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives.",[33,28],[484,485,321],"chronic hepatitis b","HBsAg","2024-02-17",{"date":488,"type":56},"2024-02-20",{"date":490,"type":56},"2023-05-11",{"date":492,"type":22},"2028-03",{"name":165,"class":140},{"id":495,"slug":496,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":501,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":513},"100511264","real-world-study-optimizing-nucleotide-analogues-100511264","NCT05937178","Real-world Study Optimizing Nucleotide-analogues","A Real-world Study of Optimizing Nucleotide-analogues-based Treatment for Chronic Hepatitis B","Inclusion Criteria:\n\n* CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months.\n* Age between 18-80 years.\n* Patient who reads and signs informed consent.\n* Meet any conditions of the group listed below\n\nGroup A-naïve and meeting the conditions that are recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline (observe-plan to treat or control-plan to follow-up) :\n\nA. HBV DNA positive, ALT is continuously upper limit of normal (male 30 U\u002FL, female 19 U\u002FL) B. HBeAg positive, HBV DNA≤2×10\\^7 IU\u002Fml; HBeAg negative, HBV DNA≥2×10\\^3 IU\u002Fml C. Meet any of the conditions listed below\n\n1. Age\\>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis;\n2. Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis;\n3. TE indicates significant fibrosis, and ≤30 years, without family history of cirrhosis or HCC\n\nGroup B-naïve and meeting the conditions that are recommended to initiate treatment in both 2019 and 2022 Chinese Guidelines, but not in EASL or AASLD guideline (observe-plan to treat or control-plan to follow-up) :\n\nA. Without cirrhosis, HBV DNA≤2000 IU\u002Fml, ALT\\>1 ULN； B. Without cirrhosis, HBV DNA\\>2000 IU\u002Fml, 1 ULN\\\u003CALT≤2 ULN； C. Without cirrhosis, normal ALT, \\>30 years, have a family history of cirrhosis or HCC, or TE indicates significant fibrosis; D. Without cirrhosis, HBV DNA 20-2000 IU\u002Fml Group C-experienced and partial response (1. switch another first-line NA; 2. add-on another first-line NA; 3. switch another first-line NA and add-on peginterferon alpha; 4. continue the original plan) Treatment experienced patient who has received a first-line nucleos(t)ide analogue(NA) monotherapy for at least 48 weeks, i.e., entecavir, tenofovir disoproxil or tenofovir alafenamide, tenofovir amibufenamide, and has partial response. They plan to continue or change the therapy\n\nExclusion Criteria:\n\n* Have poor compliance;\n* Received contraindicated concomitant drugs (subjects receiving prohibited drugs will need at least 30 days of washing out period) and known hypersensitivity reactions to the study drug, metabolites, or formulated excipients;\n* Any other clinical symptoms or previous treatment that the investigator considers that the individual subject is not suitable for this study or cannot comply with the administration requirements",{"count":502,"type":22},20000,"The goal of this multicenter, observational, prospective study is to observe and compare different anti-viral treatment strategies in a real-world cohort of patients with CHB managed in routine clinical settings in China. The main questions it aims to answer are:\n\n1. To evaluate the benefits of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who are recommended in the updated Chinese Guideline 2022, but not recommended in the Chinese Guideline 2019.\n2. To evaluate the Chinese Guideline recommends initiation of treatment, but at least one foreign authoritative guideline (eg. AASLD, EASL) does not recommend the benefit of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who initiate treatment.\n3. To compare the treatment effect of different alternatives with patients who have partial response after treatment with first-line nucleos(t)ide analogues.",[28],"2023-07-07",{"date":507,"type":56},"2023-07-10",{"date":509,"type":56},"2023-01-31",{"date":511,"type":22},"2029-01-31",{"name":350,"class":140},44,{"id":515,"slug":516,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":312,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":231},"100510120","early-phase-1-efficacy-of-na-combined-with-peg-ifn-2b-in-the-continuous-versus-pulsed-treatment-of-patients-with-chronic-hepatitis-b-100510120","NCT05922306","Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B","A Multicenter, Prospective Cohort Study: Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Patients With Chronic Hepatitis B.","EPCP","Inclusion Criteria:\n\n1. Age 18 to 60 years, both sexes (both 18 and 60 years)\n2. HBsAg positive for more than 6 months;\n3. NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU\u002Fml and HBV-DNA \\\u003C 500 IU\u002Fml at enrolment;\n4. Primary treated patients with surface antigen \\>1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B.\n5. negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age)\n\nExclusion Criteria:\n\n1. Combined active hepatitis A, C, D, E and\u002For HIV infection;\n2. Patients who are on future and intend to continue to use tibivudine\n3. methaemoglobin greater than 100ng\u002Fml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and\u002For liver imaging suggestive of liver tumours;\n4. decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin \\> 34umol\u002FL, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites;\n5. pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception\n6. Neutrophil count \\\u003C 1.5 x 10\\^9\u002FL or platelet count \\\u003C 90 x 10\\^9\u002FL and creatinine \\> 1.5 ULN\n7. History of severe psychiatric illness, especially depression. Major psychosis defined as major depressive disorder or psychosis, suicide attempts, hospitalisation for psychosis or incapacity for a period of time due to psychosis;\n8. history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies\n9. Patients with severe combined diseases of the heart, lungs, kidneys, brain, blood and other vital organs, combined with other malignancies\n10. History of severe epilepsy or current treatment with anti-epileptic drugs. Unstable control of diabetes mellitus, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or as indicated by other evidence of retinopathy;\n11. History of any organ transplantation and existing functional grafts (except corneal or hair transplants);\n12. Patients who are allergic to interferon and its drug components and who, in the judgment of the investigator, are unsuitable for interferon application\n13. Patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":523,"type":22},1084,[120],"Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.",[28],"2023-06-24",{"date":529,"type":56},"2023-06-28",{"date":531,"type":22},"2023-07",{"date":533,"type":22},"2027-12",{"name":535,"class":140},"Anhui Medical University",{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":544,"enrollmentInfo":545,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":231},"100506175","digitalized-surveillance-management-for-liver-cancer-risk-population-in-improving-eearly-diagnosis-efficancy-in-chinese-population-dsearch-100506175","NCT05870969","Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)","Exploration of A Holistic Management Procedure for Liver Cancer Surveillance in Improving Liver Cancer's Early Diagnosis Efficacy in Chinese Population: Single-Center, Prospective, Observational Real-world Study in EASTERN China","dSEARCH","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; fully informed about the study and signed informed consent, willing to follow and capable of completing all trial procedures\\[17\\]\n2. Age: 18 to 75 years old (including the cut-offs)\n3. Subjects must meet at least one of the following criteria for enrollment.\n\n   1. Patients diagnosed with chronic hepatitis B in hospital or out of hospital: persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more\n   2. Patients diagnosed with hepatitis C in hospital or out of hospital\n   3. Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria.\n\n      1. Liver biopsy showing cirrhosis (Ishak score ≥5 or Metavir score = 4);\n      2. Liver stiffness measurement (LSM) using FibroScan® (Echosens™, Paris, France) ≥12.0 kPa when TB was normal and ALT ≤ 40 IU\u002FmL, or LSM ≥ 17.0 kPa when TB was normal and ALT \\\u003C 200 IU\u002FmL;\n      3. Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities and signs of gastroesophageal varices);\n      4. APRI ≥ 2.0;\n      5. FIB-4 ≥ 3.25\n   4. Patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) in hospital or out of hospital who have a liver fibrosis score of F3 or higher according to transient elastography, i.e., FibroScan® Liver Stiffness Measurement (LSM) ≥ 10 kPa or the corresponding FibroTouch® measurement threshold\\[18\\].\n\n      * MAFLD diagnosis requires diagnosis of \\>5% fat accumulation in liver through either FibroScan® CAP measurements, or similar parameter, or liver biopsy, and in combination with one of the following three conditions: overweight\u002Fobesity (BMI \\>23 kg\u002Fm2), type 2 diabetes, or metabolic dysfunction.\n   5. Patients diagnosed with MAFLD combined with abnormal glucose metabolism\\[19\\]\n\n      * Abnormal glucose metabolism is defined as type 2 diabetes, or prediabetes, i.e. fasting blood glucose 5.6-6.9 mmol\u002FL, or 2h postprandial blood glucose 7.8-11.0 mmol\u002FL, or glycated hemoglobin 5.7%-6.4%\n   6. Subjects with a family history of liver cancer in their first-degree biological relatives.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from the study:\n\n1. Age \\\u003C18 years or \\>75 years\n2. Patients who have been diagnosed with liver cancer before enrollment\n3. Patients with severe mental illness or cognitive impairment\n4. Patients who are pregnant or lactating, or preparing to become pregnant\n5. Patients who have participated in other clinical trials or are participating in other clinical trials within 3 months prior to initiation of study treatment\n6. According to the doctor's judgment, the possibility of the subject being included is low (including inability to understand the project requirements , poor compliance, infirmity, inability to ensure that the protocol can be implemented as required, etc.), or the doctor determines that the subject has any other factors that are not suitable for this study","75 Years",{"count":502,"type":22},"The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.",[548,549,28,155,550],"Carcinoma, Hepatocellular","Hepatitis C, Chronic","Non-Alcoholic Fatty Liver Disease","2023-05-13",{"date":553,"type":56},"2023-05-23",{"date":555,"type":56},"2023-03-01",{"date":492,"type":22},{"name":558,"class":140},"Ruijin Hospital",{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":579},"100293292","real-life-cohort-study-on-patients-with-chronic-hbv-infection-in-jiangsu-100293292","NCT03097952","\"Real-life\" Cohort Study on Patients With Chronic HBV Infection in Jiangsu","\"Real-life\" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu","Inclusion Criteria:\n\n* Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)\n\nExclusion Criteria:\n\n* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and\u002For hepatitis D virus (HDV)\n* History of liver transplantation\n* History of hepatocellular carcinoma (HCC)",{"count":502,"type":22},"Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.",[569],"Hepatitis B， Chronic","2017-03-26",{"date":572,"type":56},"2017-03-31",{"date":574,"type":4},"2008-01",{"date":576,"type":22},"2030-12",{"name":578,"class":140},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",6]