Clinical trials: Hepatitis B Infections
Chronic Hepatitis b
Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets
A Randomized, Double-blind, Placebo-controlled and Multicenter Phase Ⅱ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia.
- Trial name
- NCT05637541
- Testing
- GST-HG141
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
Hepatitis B, Chronic Hep B
A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B
This study is a multicenter, open-label, phase II clinical study in subjects with chronic hepatitis B (CHB), to characterize the safety, tolerability, pharmacokinetic profile and preliminary anti-hepatitis B virus (HBV) efficacy…
- Conditions
- Hepatitis B, Chronic Hep B, HBV
- Trial name
- NCT04568265
- Testing
- APG-1387, Entecavir 0.5 mg
- Where
- 4 sites in China
- Volunteers
- 122 people
- Sponsor
- Ascentage Pharma Group Inc.
Hepatitis C
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection
- Trial name
- D-LITE (NCT01795911)
- Testing
- Pegylated Interferon Lambda, Ribasphere, Daclatasvir
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B Virus
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.
- Trial name
- NCT03294798
- Testing
- Human Serum Albumin/interferon alpha2b fusion protein, Pegasys
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Tianjin SinoBiotech Ltd.
Hepatitis B
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.
- Trial name
- NCT01777295
- Testing
- Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A., EngerixTM-B
- Where
- Belgium
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).
- Trial name
- NCT03365947
- Testing
- ARO-HBV, Sterile Normal Saline (0.9% NaCl), JNJ-56136379
- Where
- 7 sites in Australia, Hong Kong and 1 more
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Hepatitis B
REP 2139-Mg and REP 2165-Mg Combination Therapy in Chronic Hepatitis B Infection
NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients.
- Trial name
- NCT02565719
- Testing
- REP 2139-Mg, Pegasys, Viread
- Where
- 3 sites in Moldova
- Volunteers
- 40 people
- Sponsor
- Replicor Inc.
Hepatitis B
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
- Trial name
- NCT00383227
- Testing
- Hepatitis B adjuvanted vaccine
- Volunteers
- 165 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis B Infection
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare…
- Trial name
- NCT06368466
- Testing
- iStatis HBsAg Test
- Where
- Australia
- Volunteers
- 175 people
- Sponsor
- bioLytical Laboratories
Diphtheria, Tetanus
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02817451
- Testing
- Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
- Where
- South Africa
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics…
- Trial name
- NCT05763576
- Testing
- RO7565020, Nucleos(t)ide analogue (NUC) treatment
- Where
- 9 sites in United States, Hong Kong and 5 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
- Trial name
- NCT05808374
- Testing
- HRS-5635
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Hepatitis B
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.
- Trial name
- NCT00343915
- Testing
- Engerix™-B (thiomersal-free) 20µg, 10 μg Engerix™-B (preservative-free)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine.
- Trial name
- NCT00414050
- Testing
- Modified Process Hepatitis B Vaccine (Experimental), Hepatitis B Vaccine (Recombinant)
- Volunteers
- 1,718 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.
- Trial name
- NCT00131742
- Testing
- telbivudine, lamivudine
- Where
- China
- Sponsor
- Novartis
Chronic Hepatitis b
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®)…
- Trial name
- NCT03847246
- Testing
- Baraclude® tablets,1.0 mg, Entecavir tablets,1.0 mg
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatitis B, Chronic
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having…
- Trial name
- NCT00838071
- Testing
- Specific intravenous anti-hepatitis B immunoglobulin
- Where
- 4 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Instituto Grifols, S.A.
Healthy, Hepatitis B, Chronic
A Single and Multiple Ascending Dose Study of JNJ-64457744
The purpose of the study is to evaluate the safety and tolerability of: single ascending dose (SAD) and multiple ascending dose (MAD) administration of JNJ-64457744, administered to healthy adult participants (Part 1 and Part 3)…
- Trial name
- NCT05423106
- Testing
- JNJ-64457744, Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF)
- Where
- New Zealand
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B
Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children
This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.
- Trial name
- NCT01138098
- Testing
- Engerix™-B
- Where
- 11 sites in Slovakia
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection
The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.
- Trial name
- NCT05242445
- Testing
- Cetrelimab
- Where
- 13 sites in Belgium, France and 3 more
- Volunteers
- 11 people
- Sponsor
- Janssen Research & Development, LLC