Clinical trials: Hepatitis B Infections
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24…
- Trial name
- ASTRAL-4 (NCT02201901)
- Testing
- SOF/VEL, RBV
- Where
- 50 sites in United States, Puerto Rico
- Volunteers
- 268 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B
This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine.
- Trial name
- NCT01705704
- Where
- 27 sites in Australia, France and 8 more
- Volunteers
- 269 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered…
- Trial name
- NCT00697216
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Where
- 2 sites in Belgium, Denmark
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis A
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00197184
- Testing
- Twinrix™ Adult, Twinrix™ Junior
- Where
- 7 sites in Australia, Belgium and 1 more
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B Virus (HBV) Infection
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection…
- Trial name
- NCT06650852
- Testing
- BRII-179, BRII-835 (VIR-2218), PEG-IFNα
- Where
- 14 sites in China
- Volunteers
- 250 people
- Sponsor
- Brii Biosciences Limited
Chronic Hepatitis B
Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus
This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months
- Trial name
- NCT02899130
- Testing
- Polyherbal
- Where
- India
- Volunteers
- 80 people
- Sponsor
- Composite Interceptive Med Science
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01948193
- Testing
- Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
- Where
- 2 sites in India
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.
- Trial name
- NCT03173599
- Testing
- PNA 40mg, PNA 80mg, PNA 160mg
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
Chronic Hepatitis B
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)
- Trial name
- NCT03577171
- Testing
- ABI-H0731, SOC ETV
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 25 people
- Sponsor
- Assembly Biosciences
Chronic Hepatitis B Virus
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AHB-121 injection in healthy and chronic hepatitis B participants.
- Trial name
- NCT07884864
- Testing
- AHB-121
- Where
- China
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Ausper Biopharma Co., Ltd.
Hepatitis B, Chronic
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0…
- Trial name
- NCT00536263
- Testing
- pegylated interferon alpha-2b
- Volunteers
- 671 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetics(PK), Pharmacodynamics(PD) and Food Effect of HRS9950 in Healthy and CHB Subjects
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS9950.
- Trial name
- NCT04464733
- Testing
- HRS9950
- Where
- China
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatitis, Hepatitis B
Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates
The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.
- Conditions
- Hepatitis, Hepatitis B, Liver Diseases, Digestive System Diseases
- Trial name
- NCT02764671
- Testing
- 10μg/0.5ml recombinant hepatitis B vaccine
- Where
- 2 sites in China
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Shenzhen Kangtai Biological Products Co., LTD
Hepatitis B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients.
- Trial name
- NCT01379508
- Testing
- telbivudine, tenofovir disoproxil fumarate
- Where
- 34 sites in Austria, Bulgaria and 6 more
- Volunteers
- 241 people
- Sponsor
- Novartis Pharmaceuticals
Immunologic Tests
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
- Trial name
- NCT01098006
- Testing
- Blood withdrawal
- Where
- 2 sites in Belgium
- Volunteers
- 99 people
- Sponsor
- GlaxoSmithKline
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis b, Liver Inflammation
Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium…
- Trial name
- MAGIC-101 (NCT03349008)
- Testing
- Entecavir, Magnesium Isoglycyrrhizinate, Diammonium Glycyrrhizinate
- Volunteers
- 480 people
- Sponsor
- Cttq
Advanced Melanoma, Hepatitis B
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C…
- Conditions
- Advanced Melanoma, Hepatitis B, Hepatitis C
- Trial name
- Yervoy RMP (NCT02402699)
- Where
- Taiwan
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb