[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-chronic-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-chronic-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100639893","phase-1-safety-and-antiviral-activity-of-a-monoclonal-hepatitis-b-antibody-a-phase-1b-open-label-trial-in-individuals-with-chronic-hepatitis-d-infection-100639893",false,"NCT07610772","Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection","Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection (the SAMBA-D Study)","Inclusion Criteria:\n\n* HDV infection confirmed by positive anti-HDV antibody and detectable HDV RNA\n* HBs antibody negative during screening period\n* Both HBeAg positive and negative participants are included\n* Ability and willingness to provide informed consent\n* Participants who can become pregnant must agree to use two methods of contraception:\n* Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant.\n\nExclusion Criteria:\n\n* Child-Turcotte-Pugh \\>9 points\n* Severe clinical hepatic decompensation-such as hepatic encephalopathy or variceal hemorrhage-occurring currently or within the past 12 months.\n* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable)\n* Pregnancy or lactation\n* Any vaccination 2 weeks prior to entry\n* Prior receipt of HepB mAb19 therapy\n* Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness 2 weeks prior to entry\n* Active hepatitis C infection\n* Untreated HIV disease\n* Individuals with HIV receiving antiretroviral therapy who have had a measurement of plasma HIV RNA (viral load) \\>50 copies\u002FmL within the past 6 months are excluded. However, a single viral load measurement between \\>50 and \\\u003C500 copies\u002FmL during this period is acceptable.\n* Participation in another clinical study of an investigational product currently or 12 weeks prior to entry, or expected participation during this study\n\nLaboratory abnormalities in the parameters listed below:\n\n* Alpha fetoprotein \\>100 ng\u002FmL\n* Hemoglobin \\\u003C10 gm\u002FdL (6.21 mmol\u002FL)\n* Platelet count \\\u003C25,000 \u002Fmm3\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\n* ALT ≥ x10 upper limit of normal (ULN)\n\nCurrent, or history of:\n\n* Clinical cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure.\n* Presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., PR interval \\>210 ms (1st degree AV block only if clinical symptoms are present), QT corrected for heart rate using the Fridericia's correction factor \\[QTcF\\] \\> 450 ms for males and QTcF \\>470 ms for females);\n* Chronic liver disease from another cause, ICD, or autoimmune diseases that in the opinion of the investigator would preclude participation\n* History of hematopoietic stem cell transplant or solid organ transplant","ALL","18 Years","70 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Hepatitis D virus (HDV) is a major global health issue, with an estimated 12 million people living with the infection worldwide. HDV infection requires the presence of hepatitis B virus (HBV), as it relies on hepatitis B virus for replication within the liver cells. Treatment options for HDV are limited and cannot cure the infection. The combination of concurrent HBV and HDV increases the risk of developing severe liver disease, including cirrhosis and liver cancer. This risk would significantly decrease if HDV is eliminated or reduced. Consequently, there is a need for the development of new treatment options.\n\nColleagues at Rockefeller University in New York have identified the antibody HepB mAb19, which effectively reduces the amount of circulating HBV antigens. Since HDV depends on HBV to replicate, we will test this antibody as a potential treatment for HDV.\n\nThe trial design is a phase 1b open-label aiming at including 15 study participants with chronic hepatitis D infection. All study participants will receive two or three dosis of the antibody, HepB mAB19, and will be followed for 60 weeks after the first HepB mAb19 infusion.\n\nThis study will evaluate the safety and pharmacokinetics of this antibody, as well as its potential effects on viral levels of HDV RNA and antiviral immune responses in individuals living with chronic HDV infection.",[27,28],"Hepatitis D, Chronic","Hepatitis B Chronic Infection",[30,31],"SAMBA-D","2025-522125-36-00 (EU CT no.)","RECRUITING","2026-05-27",{"date":35,"type":36},"2026-05-28","ACTUAL",{"date":38,"type":36},"2026-04-23",{"date":40,"type":21},"2028-04-01",{"name":42,"class":43},"Aarhus University Hospital","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"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.","65 Years",{"count":53,"type":21},156,[55],"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",[58,59,28],"Hepatocellular Carcinoma","HEPATITIS B CHRONIC",[61,62,63,64],"Peg-IFN-α-2b","hepatitis B","hepatocellular carcinoma","prognosis","NOT_YET_RECRUITING","2026-04-20",{"date":68,"type":36},"2026-04-28",{"date":70,"type":21},"2026-03-31",{"date":72,"type":21},"2035-12-31",{"name":74,"class":43},"Ningbo No.2 Hospital",4]