Clinical trials: Hepatitis B Infections
Chronic Hepatitis B
Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China
To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination…
- Trial name
- EVOLVE (NCT01726439)
- Where
- 54 sites in China
- Volunteers
- 3,434 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF) 300 mg in Chinese subjects to support the registration of this compound in the People's Republic of China.
- Trial name
- PK of TDF (NCT01480622)
- Testing
- TDF tablets
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Pertussis
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B).
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01362517
- Testing
- Quinvaxem
- Where
- Vietnam
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Chronic Hepatitis b
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.
- Trial name
- NCT04980482
- Testing
- AB-729, Peg-IFNα-2a
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 43 people
- Sponsor
- Arbutus Biopharma Corporation
Hepatitis B, Chronic
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC).
- Trial name
- NCT02224456
- Testing
- Tenofovir disoproxil fumarate
- Where
- 19 sites in China
- Volunteers
- 197 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different…
- Trial name
- NCT00697229
- Testing
- Engerix™-B, HBV-MPL vaccine
- Where
- Belgium
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation).
- Trial name
- NCT04083716
- Testing
- ABI-H2158 Reference Formulation, ABI-H2158 Test Formulation
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Chronic Hepatitis B
Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B
This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.
- Trial name
- NCT00606099
- Testing
- telbivudine, adefovir dipivoxil
- Where
- 3 sites in United States
- Sponsor
- Novartis
Hepatitis B
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
This study will evaluate the immune response of healthy subjects who received neonatal vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago.
- Trial name
- NCT00774995
- Testing
- EngerixTM-B
- Where
- Thailand
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
- Trial name
- NCT00645294
- Testing
- Adefovir dipivoxil
- Where
- 10 sites in Belgium, Germany and 2 more
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B.
- Trial name
- NCT00116805
- Testing
- TDF, ADV, FTC/TDF
- Where
- 87 sites in United States, Australia and 13 more
- Volunteers
- 266 people
- Sponsor
- Gilead Sciences
Whole Cell Pertussis, Diphtheria
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
- Conditions
- Whole Cell Pertussis, Diphtheria, Hepatitis B, Tetanus
- Trial name
- NCT00169442
- Testing
- Tritanrix™-HepB/Hiberix™ Kft., Tritanrix™-HepB/Hiberix™, Hiberix™
- Where
- 3 sites in Philippines
- Volunteers
- 745 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients
This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.
- Trial name
- HBV (NCT03485534)
- Testing
- Tenofovir Disoproxil Fumarate, Tenofovir Disoproxil
- Where
- South Korea
- Volunteers
- 189 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Hepatitis B, Chronic
A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01086085
- Testing
- Adefovir, peginterferon alfa-2a [PEGASYS]
- Where
- 11 sites in China
- Volunteers
- 265 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B.
- Trial name
- NCT01730508
- Testing
- Pegylated Interferon Alfa (Peginterferon Alfa)
- Where
- 88 sites in China
- Volunteers
- 978 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
The Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules
The Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B
- Trial name
- NCT03638076
- Testing
- GLS4, RTV
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Chronic Hepatitis B
A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine
The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.
- Trial name
- NCT00036608
- Testing
- Entecavir
- Where
- 39 sites in United States
- Sponsor
- Bristol-Myers Squibb
Liver Fibrosis
ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard).
- Trial name
- NCT02313649
- Where
- 15 sites in China
- Volunteers
- 447 people
- Sponsor
- SuperSonic Imagine
Chronic Hepatitis B
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only…
- Trial name
- NCT04423393
- Testing
- VIR-3434
- Where
- 24 sites in Germany, Hong Kong and 5 more
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Hepatitis B, Hepatitis A
Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.
- Trial name
- NCT02135666
- Testing
- Blood sampling
- Where
- Czechia
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline