[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fujian Akeylink Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,63],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100637428","phase-3-phase-iiib-extension-clinical-trial-of-efficacy-and-safety-of-gst-hg141-nairevir-combined-with-nas-in-chronic-hepatitis-b-100637428",false,"NCT07588009","Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis B","A Single-Arm, Open-Label, Multicenter Phase IIIB Extension Clinical Trial to Evaluate the Efficacy and Safety of GST-HG141 (Nairecovir) in Combination With Nucleos(t)Ide Analogs (NAs) in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n1. Participants who received the study treatment of the phase III clinical trial of GST-HG141 (GST-HG141-III-01) in accordance with the protocol requirements (participants without early withdrawal and with overall medication compliance ≥ 80%), and had ALT ≤ 5×ULN;\n2. Participants were willing to participate in the study and were judged by the investigator to be suitable for long-term treatment with GST-HG141 combined with NAs;\n3. Male participants with female partners of childbearing potential or female participants of childbearing potential voluntarily adopted effective contraceptive measures from screening to 28 days after study withdrawal ;\n4. Signed the informed consent form prior to the trial and were able to complete the study in accordance with the requirements of the trial protocol.\n\nExclusion Criteria:\n\n1. Presence of severe systemic infection requiring treatment;\n2. Suffering from clinically significant acute or chronic liver diseases not caused by HBV infection;\n3. Participants with a history of liver cirrhosis; or currently diagnosed or suspected decompensated liver cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, esophagogastric variceal bleeding, splenomegaly, ascites, etc.; or participants with significant progression of liver fibrosis;\n4. Primary liver cancer; suspected malignant space-occupying liver lesions suggested by imaging examination; combined with other malignant tumors (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix);\n5. Impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs as judged by the investigator;\n6. Combined with severe diseases of the circulatory, respiratory, urinary, hematological, metabolic, immune, psychiatric, neurological, renal and other systems, and judged by the investigator to be ineligible for continued participation in the study;\n7. Participants with major trauma or major surgery within 3 months prior to screening; or those planning to undergo surgery during the study period;\n8. Laboratory test abnormalities:\n\n   1. Platelet count \\\u003C 100×10\\^9\u002FL;\n   2. White blood cell count \\\u003C 3.0×10\\^9\u002FL;\n   3. Absolute neutrophil count \\\u003C 1.3×10\\^9\u002FL;\n   4. Serum total bilirubin \\> 2×ULN;\n   5. Albumin \\\u003C 35 g\u002FL;\n   6. Estimated glomerular filtration rate (eGFR) ≤ 60 ml·min-¹·(1.73m²)-¹ ;\n   7. International Normalized Ratio (INR) of prothrombin time \\> 1.5;\n9. Lactating females or participants with a positive pregnancy test;\n10. Participants with any other conditions deemed inappropriate for participation in this trial by the investigator.","ALL","18 Years","71 Years",{"count":20,"type":21},576,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, single-arm, open-label, phase IIIb extension clinical trial designed to evaluate the long-term safety and tolerability of GST-HG141 (nerlecovir, 50 mg BID) in combination with nucleos(t)ide analogues (NAs) in patients with chronic hepatitis B (CHB) who completed 48 weeks of treatment in the phase III study (GST-HG141-III-01), did not discontinue prematurely, had an overall medication compliance rate of ≥80%, and were willing to continue treatment.\n\nA maximum of 578 eligible participants will be enrolled at 64 centers, including those who completed the preceding study, had ALT ≤5× upper limit of normal (ULN), and had no severe comorbidities (e.g., decompensated cirrhosis, other viral infections, or malignant tumors)",[27],"Chronic Hepatitis b","NOT_YET_RECRUITING","2026-05-08",{"date":31,"type":32},"2026-05-14","ACTUAL",{"date":34,"type":21},"2026-06-26",{"date":36,"type":21},"2028-03-01",{"name":38,"class":39},"Fujian Akeylink Biotechnology Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100599920","phase-3-to-evaluate-the-efficacy-safety-and-population-pharmacokinetics-of-gst-hg141-in-patients-with-chronic-hepatitis-b-chb-who-have-an-inadequate-response-to-antiviral-drug-treatment-100599920","NCT07090759","To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment","A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Trial of GST-HG141（Neracorvir）for Combination Therapy (add-on) in Patients With Inadequate Response to Antiviral Drugs in Chronic Hepatitis B (CHB)","Inclusion Criteria:\n\n1. Male or female individuals aged 18-70 years (inclusive of the boundaries);\n2. Male weight ≥ 50 kg, female weight ≥ 45 kg, with a body mass index (BMI) within the range of 18-35 kg\u002Fm2 (inclusive of the boundaries);\n3. Have been continuously taking nucleoside analogues (entecavir \\[ETV\\], tenofovir disoproxil fumarate \\[TDF\\], emivirofavir \\[TMF\\], or propivirofavir \\[TAF\\]) for more than one year (with a break of less than one month in the past year), and are receiving treatment at the time of screening and agree to accept the treatment plan provided by this study during the study period;\n\n   \\* Have maintained the same NA monotherapy for more than 3 months before screening\n4. HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA \\> 50 IU\u002FmL;\n5. At the time of screening, ALT ≤ 5×ULN;\n6. Male participants with a fertile female partner or female participants of childbearing age who are willing to voluntarily take effective contraceptive measures from the time of screening until 28 days after the completion of the study ;\n7. Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol.\n\nExclusion Criteria:\n\n1. History of life-threatening severe allergic reactions such as anaphylactic shock, or allergy to the active ingredients or excipients of the study drug as suspected by the investigator;\n2. Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening;\n3. Systemic use of immunosuppressants, immunomodulators (interferon must be discontinued for more than 12 months), or cytotoxic drugs within 6 months prior to screening; or vaccination with live attenuated vaccines within 1 month prior to screening;\n4. Presence of acute infections requiring treatment prior to randomization;\n5. Clinically significant acute or chronic liver disease not caused by HBV infection, rendering the subject unsuitable for participating in the study as determined by the investigator;\n6. Subjects with a history of cirrhosis (e.g., subjects who have undergone pathological examination of liver tissue with a report indicating cirrhosis or those who have undergone endoscopy indicating esophageal or gastric varices); or subjects with currently diagnosed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal or gastric varices, splenomegaly, and ascites; or subjects with significant progression of liver fibrosis;\n7. Primary liver cancer; serum alpha-fetoprotein (AFP) greater than 20 μg\u002FL (or 20 ng\u002FmL) or DCP\\>40 mAU\u002FmL or imaging suggesting possible malignant lesions in the liver; concurrent other malignancies or history of other malignancies within the past 5 years (except for cured basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ);\n8. Presence of gastrointestinal impairment or gastrointestinal disease that may affect the absorption of oral medication in the judgment of the investigator, such as severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, Grade \\> 2 gastrointestinal symptoms at screening (e.g., nausea, vomiting, or diarrhea), etc.;\n9. Concurrent severe diseases of the circulatory, respiratory, urinary, hematologic, metabolic, immune, psychiatric, neurological, renal, or other systems, rendering the subject unsuitable for participating in the study as determined by the investigator.\n10. Subjects with major trauma or major surgery within 3 months prior to screening; or those who plan to undergo surgery during the study period;\n11. Laboratory tests:\n\n    1. Platelet count \\\u003C 100 × 109\u002FL;\n    2. White blood cell count \\\u003C 3.0 × 109\u002FL;\n    3. Absolute neutrophil count \\\u003C 1.3 × 109\u002FL;\n    4. Serum total bilirubin \\> 2× ULN;\n    5. Albumin \\\u003C 35 g\u002FL;\n    6. GFR ≤ 60 mL·min-1·(1.73 m2)-1 (calculated using the CKD-EPI formula);\n    7. International normalized ratio (INR) of prothrombin time \\>1.5;\n12. Positive for hepatitis C antibody, positive for HIV antigen\u002Fantibody, or positive for syphilis antibody with a positive RPR or TRUST test result;\n13. History of sustained alcohol abuse within the past 3 years (weekly alcohol intake \\> 14 units, where 1 unit of alcohol equals 1 bottle of 350 mL beer, 120 mL wine, or 30 mL of spirits at 40% alcohol content);\n14. History of drug dependence or substance abuse;\n15. Participation in clinical trials involving other investigational drugs or medical devices and receiving the investigational drug or using the medical device within 3 months prior to screening;\n16. Women who are breastfeeding or tested positive for pregnancy;\n17. Determined by the investigator to be unsuitable for this trial for any other reasons.","70 Years",{"count":49,"type":21},526,[24],"This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.",[27],"RECRUITING","2026-01-22",{"date":56,"type":32},"2026-01-23",{"date":58,"type":32},"2025-07-24",{"date":60,"type":21},"2027-03-01",{"name":38,"class":39},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":62},"100536371","phase-2-a-randomized-double-blind-placebo-controlled-phase-iia-clinical-study-to-evaluate-the-safety-and-efficacy-of-gst-hg131-tablets-in-patients-with-chronic-hepatitis-b-100536371","NCT06263959","A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n1. Able to sign the informed consent form，and fully understand the test content, process and possible adverse reactions；\n2. Males and females aged 35-65 ,able to complete research in accordance with test plan requirements;\n3. Participants who have no childbearing plan in next year,and must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 6 months after the last dose of the study；\n4. The weight of male patients shall not be less than 50 kg, and the weight of female patients is not less than 45 kg. Body mass index (BMI = weight (kg)\u002Fheight 2 (m2)) in the range of 18.0\\~35.0 kg\u002Fm2；\n5. Participants who have received stable NA therapy for more than half a year and have maintained the NA regimen for ≥3 months prior to screening；\n6. At least two tests within 28 days of the screening period (more than 1 week apart) with HBV DNA lower than LLOQ；\n7. HBeAg negative, 100≤HBsAg quantitative ≤1500 IU\u002FmL, serum ALT\\\u003C1×ULN during screening;\n8. The normal or abnormal results of vital signs assessment, physical examination and 12-lead electrocardiogram during the screening period and baseline period have no clinical significance；\n9. Able to communicate well with clinical staff and complete the trial according to protocol requirements。\n\nExclusion Criteria:\n\n1. Participants with a history of allergy to the any ingredient or excipients of the drug under study；\n2. Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting；\n3. Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study；\n4. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or received blood transfusion; or blood donation or blood loss ≥200 mL within 1 month prior to screening；\n5. A history of alcohol or drug abuse or dependence；\n6. Participants have participated in clinical trials of drugs or medical devices (except in vitro diagnostic reagents) within 3 months prior to administration；\n7. Use of any hepatitis B drug other than NUC within 1 year prior to administration；\n8. Participants with systemic use of immunosuppressants, immunomodulators (excluding interferon) and cytotoxic drugs within 6 months before screening; Or those who received live attenuated vaccine within 1 month before screening；\n9. Participants with clinically significant acute or chronic liver disease caused by non-HBV infection who were judged by the investigator to be unsuitable for the study；\n10. Participants with a history of cirrhosis (e.g., the subject had a histopathological examination of the liver and reported cirrhosis, or had an endoscopic examination indicating varicose esophagus and fundus veins);\n11. Participants with hepatitis B cirrhosis in the confirmed or suspected decompensated stage, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, esophageal and fundus variceal bleeding, spleen enlargement, ascites, primary liver cancer, etc；\n12. Participants with malignancy or history of other malignancies within 5 years prior to screening (except cured basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)；\n13. The investigators determined the presence of impaired gastrointestinal function or gastrointestinal disease that might affect oral drug absorption, such as severe gastrointestinal disease (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, and gastrointestinal symptoms \\> grade 2 at the time of screening (e.g., nausea, vomiting, or diarrhea)；\n14. Participants with suspected or confirmed acute infections within 2 weeks prior to randomization；\n15. Laboratory examination: platelet count \\\u003C 90 x 10\\^9 \u002F L; White blood cell count \\\u003C3.0 x 10\\^9 \u002F L; Neutrophils absolute value\\\u003C 1.3 x 10\\^9 \u002F L; Serum total bilirubin \\>2 x ULN. Albumin\\\u003C 30 g\u002FL; Creatinine clearance ≤ 60 mL\u002Fmin or less; Prothrombin time international standardization ratio (INR) \\>1.5；\n16. Serum AFP (AFP) is greater than 50 ㎍ \u002F L (or 50 ng\u002FmL) or imaging suggest possible malignant liver placeholder；\n17. Hepatitis C antibody positive, treponema pallidum antibody positive and rapid plasma reagin test (RPR) positive,AIDS antigen\u002Fantibody positive；\n18. Breastfeeding women or those who have a positive pregnancy test at screening or baseline；\n19. The investigator believes that there are other subjects who are not suitable for participating in this trial.","35 Years","65 Years",{"count":72,"type":21},45,[74],"PHASE2","A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B",[77],"Chronic Hepatitis B","2025-03-03",{"date":80,"type":32},"2025-03-05",{"date":82,"type":32},"2023-12-26",{"date":84,"type":21},"2025-05-01",{"name":38,"class":39},""]