[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grand Theravac Life Sciences (Nanjing) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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},"100644760","phase-1-clinical-trial-to-evaluate-the-safety-tolerability-and-pharmacokinetic-profile-of-tvax-028-in-the-treatment-of-chronic-hepatitis-b-100644760",false,"NCT07673068","Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B","Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 Injection in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures.\n* 2\\. Male or female, aged 18 to 65 years.\n* 3\\. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria.\n* 4\\. Is receiving stable antiviral treatment with a single nucleos(t)ide analogue before enrollment. Has adequately suppressed HBV DNA and acceptable liver function based on protocol-defined criteria before the first administration of adjuvant or TVAX-028.\n* 5\\. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria.\n* 6\\. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-028.\n* 7\\. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment.\n* 8\\. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period.\n\nExclusion Criteria:\n\n* 1\\. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results\n* 2\\. Has evidence or suspected evidence of hepatocellular carcinoma, cirrhosis, clinically significant hepatic space-occupying lesions, or clinically significant liver fibrosis based on imaging, laboratory testing, or non-invasive liver assessment.\n* 3\\. Has clinically significant abnormalities in laboratory tests, including but not limited to liver function, renal function, hematology, coagulation, or electrolyte parameters, based on protocol-defined criteria.\n* 4\\. Has received interferon or pegylated interferon treatment within the protocol-defined period before the first administration of adjuvant or TVAX-028, or plans to receive such treatment during the study.\n* 5\\. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028.\n* 6\\. Has received corticosteroid therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for permitted topical or inhaled corticosteroids.\n* 7\\. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments.\n* 8\\. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria.\n* 9\\. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection.\n* 10\\. Has a history of malignancy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for conditions permitted by the protocol.\n* 11\\. Has previously received organ transplantation.\n* 12\\. Has a history of severe drug and food allergy, or is known to be allergic to any component of the investigational product or related products.\n* 13\\. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose.\n* 14\\. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures.\n* 15\\. Has a history of severe allergy, or is known or suspected to be allergic to any component of the investigational product, adjuvant, or related products.\n* 16\\. Has participated in another clinical trial of an investigational drug, biologic, medical device, or vaccine within the protocol-defined period before the first administration of adjuvant or TVAX-028.\n* 17\\. Is pregnant or breastfeeding.\n* 18\\. Is considered by the investigator to be unsuitable for participation in this study for any other reason.","ALL","18 Years","65 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts. The study is designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of TVAX-028 in patients with chronic hepatitis B virus infection",[27],"HBV Infection","NOT_YET_RECRUITING","2026-06-24",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":21},"2026-05-31",{"date":36,"type":21},"2027-05-31",{"name":38,"class":39},"Grand Theravac Life Sciences (Nanjing) 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":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100614642","phase-3-clinical-trial-to-evaluate-the-efficacy-and-safety-of-tvax-008-injection-in-the-treatment-of-chronic-hepatitis-b-100614642","NCT07282249","Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B","A Multicenter, Randomized, Placebo-Controlled and Positive-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis B","Inclusion Criteria:\n\n* Male or female, aged 18 to 65 years (inclusive);\n* Clinically diagnosed chronic hepatitis B (serum HBsAg positive ≥6 months);\n* Subjects with a history of nucleoside (acid) analog anti-hepatitis B therapy lasting ≥6 months until screening, currently receiving antiviral therapy with a single nucleoside (acid) analog \\[eg, tenofovir fumarate (TAF), amitenofovir (TMF), tenofovir disoform fumarate (TDF) or entecavir (ETV), etc.\\], and HBV DNA\\\u003C100 IU\u002FmL within 28 days prior to the first dose of investigational product;\n* Hepatitis B virus e antigen (HBeAg) negative within 28 days prior to first use of investigational product;\n* HBsAg\\>0.05 IU\u002FmL and HBsAg\\\u003C100 IU\u002FmL within 28 days prior to first use of investigational product;\n* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2× upper limit of normal (ULN) within 28 days prior to the first dose of investigational product;\n* Antinuclear antibodies (ANA) negative, or abnormal but not supportive of diagnosis of autoimmune liver disease in the investigator's judgment;\n\nExclusion Criteria:\n\n* Liver disease caused by other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, hemochromatosis, etc.;\n* In addition to chronic hepatitis B, clinically important chronic diseases that, in the opinion of the investigator, make the patient unsuitable for participation in the study, including but not limited to thyroid disease requiring clinical intervention or clinically significant thyroid dysfunction, fundus disease (e.g. retinopathy), chronic lung disease with lung dysfunction, history of severe seizures or current use of antiepileptic drugs, immunodeficiency or autoimmune disease;\n* Laboratory indicators or symptoms meet one or more of the following:\n\n  1. Blood phosphorus \\\u003C0.65 mmol\u002FL;\n  2. Serum albumin \\\u003C35 g\u002FL;\n  3. Total bilirubin\\>1.5×ULN;\n  4. Hemoglobin \\\u003C100 g\u002FL;\n  5. Prothrombin time international normalized ratio (INR) ≥1.5;\n  6. Past or present ascites, variceal bleeding, hepatorenal syndrome, hepatic encephalopathy or liver failure;Child-Pugh score B\u002FC (see Appendix 1 for Child-Pugh classification criteria);\n  7. Platelet count \\\u003C125×109\u002FL;\n  8. WBC count \\\u003C3×109\u002FL;\n  9. Absolute neutrophil count \\\u003C1.5×109\u002FL;\n  10. Estimated glomerular filtration rate (eGFR)\\\u003C50 mL\u002Fmin\u002F1.73m2\\[calculated using the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI formula), see Appendix 2 for CKD-EPI formula\\];\n  11. Imaging results show hepatocellular carcinoma, cirrhosis or liver mass (except liver cyst or hemangioma), or alpha-fetoprotein (AFP) ≥20 μg\u002FL, or FibroScan®\u002FFibroTouch® liver stiffness value (LSM)\\>10.6 kPa;\n  12. Serum ceruloplasmin (CP) results suggest an increased risk of metabolic disease;\n* Use of immunosuppressants within 6 months prior to first use of investigational product;\n* Treatment with corticosteroids (other than topical or inhaled corticosteroids) lasting for 1 week or more within 6 months prior to first use of investigational product;\n* Hepatitis C virus (HCV) antibody positive and HCV RNA positive; or hepatitis D virus (HDV) antibody positive; or human immunodeficiency virus (HIV) antibody positive; or Treponema pallidum (TP) antibody positive \\[except for rapid plasma reagin circular card test (RPR) or toluidine red unheated serum test (TRUST) negative\\];\n* History of malignant tumor or recurrence within 5 years prior to the first use of investigational product;\n* Previous organ transplant;\n* Severe cardiac disease \\[including myocardial infarction, unstable angina, heart failure (New York Heart Association (NYHA) Functional Class III or IV, NYHA Functional Class criteria see Appendix 3)\\], renal failure, or pancreatitis;\n* Diabetes mellitus with unstable drug control \\[glycosylated hemoglobin (HbA1c) ≥7.5%\\] or hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n* History of severe drug or food allergy;\n* History of alcohol or drug abuse within 6 months prior to screening (mean alcohol consumption in ethanol: \\>40 g\u002Fday for men and\\>20 g\u002Fday for women);\n* A past or current diagnosis of mental illness, especially depression or depressive tendencies;\n* Use of other investigational drugs or biologics within 30 days or 5 drug half-lives (whichever is longer) prior to first use of investigational product; or participation in a clinical trial of a medical device, drug or vaccine at screening;\n* Subjects who have previously taken the investigational drug TVAX-008 injection within 1 year;\n* In the opinion of the investigator, participation in this trial is not appropriate due to other reasons.",{"count":48,"type":21},630,[50],"PHASE3","This is a multicenter, randomized, placebo-controlled (double-blind design) versus active-controlled (open-label design) Phase I clinical trial evaluating the efficacy and safety of TVAX-008 injection in subjects with chronic hepatitis B.",[53],"Chronic hepatitisB","2025-12-11",{"date":56,"type":32},"2025-12-15",{"date":58,"type":21},"2025-12-31",{"date":60,"type":21},"2027-12-31",{"name":38,"class":39},""]