Clinical trials: Hepatitis b Virus
Hepatitis B
Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
This study was a comparative, randomized, double-blind clinical study of the efficacy and safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel groups of hepatitis B-naive healthy adult…
- Trial name
- NCT04209400
- Testing
- Sci-B-Vac®, Engerix-B®
- Where
- Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Hepatitis B, Chronic
A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)
This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability.
- Trial name
- NCT00651209
- Testing
- Tenofovir
- Where
- 4 sites in Argentina, Brazil and 2 more
- Volunteers
- 105 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B Infection
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.
- Trial name
- NCT00371150
- Testing
- Entecavir
- Where
- 27 sites in United States, Brazil and 3 more
- Volunteers
- 131 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of Sci-B-Vac vaccine produced…
- Trial name
- NCT04531098
- Testing
- Sci-B-Vac-Lot B, Sci-B-Vac-Lot A, Engerix-B
- Where
- Vietnam
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Hepatitis B, Chronic Disease
Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program
The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these…
- Trial name
- NCT00096811
- Testing
- Entecavir
- Where
- 5 sites in Israel
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic Hepatitis B
Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers
This is an open-label, randomized, multi-part study to evaluate the relative oral bioavailability of a tablet formulation of AL-3778 (formerly NVR 3-778) administered under fasted and fed conditions (Parts 1 and 2) and the…
- Conditions
- Hepatitis B, Chronic Hepatitis B, Viral Hepatitis B
- Trial name
- NCT03032536
- Testing
- AL-3778, Entecavir, Tenofovir disoproxil fumarate
- Where
- 2 sites in New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Liver Fibrosis, Liver Fibrosis in Chronic Hepatitis B
A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.
This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy.
- Trial name
- NCT07412236
- Testing
- Hydronidone (270mg)
- Where
- China
- Volunteers
- 1,208 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Chronic Hepatitis B
Study of ARC-520 in Patient With Chronic Hepatitis B Virus
Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
- Trial name
- NCT02349126
- Testing
- ARC-520 Injection
- Where
- Australia
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Hepatitis B
A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied.
- Trial name
- NCT04846491
- Testing
- Peginterferon alfa-2b injection, TDF
- Where
- 33 sites in China
- Volunteers
- 475 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatitis B Vaccine
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy.
- Trial name
- NCT00519649
- Testing
- Engerix™-B Kinder
- Where
- 35 sites in Germany
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™.
- Trial name
- NCT00445185
- Testing
- Henogen HB vaccine, Fendrix vaccine
- Where
- 23 sites in Belgium, Czechia and 1 more
- Volunteers
- 102 people
- Sponsor
- Henogen
Chronic Hepatitis D Infection With Hepatitis B
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients…
- Trial name
- NCT03546621
- Testing
- Myrcludex B, Myrcludex-B, Tenofovir
- Where
- 15 sites in Germany, Russia
- Volunteers
- 120 people
- Sponsor
- Hepatera Ltd.
Chronic Hepatitis B Virus Infection, Hepatitis B
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy.
- Trial name
- B-UNITED (NCT06537414)
- Testing
- Daplusiran/Tomligisiran Dose Level 1, Daplusiran/Tomligisiran Dose Level 2, Bepirovirsen
- Where
- 80 sites in United States, Australia and 17 more
- Volunteers
- 283 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
The purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg…
- Trial name
- NCT02153320
- Testing
- Blood Sampling
- Where
- 2 sites in Belgium
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HBV, Hepatitis B
Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients
A single center, open-label, study to evaluate the intra-hepatic effect of inarigivir dose per day and three times per week on immune response and viral markers in virally suppressed patients with chronic hepatitis B infection
- Conditions
- HBV, Hepatitis B, Hepatitis B, Chronic
- Trial name
- NCT03932513
- Testing
- inarigivir soproxil
- Where
- Singapore
- Volunteers
- 8 people
- Sponsor
- F-star Therapeutics, Inc.
Chronic HBV Infection
A Long-term Observational Study in Participants Who Have Received PBGENE-HBV
Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.
- Trial name
- ELIMINATE-B (NCT07254208)
- Testing
- PBGENE-HBV
- Where
- 4 sites in United States, Hong Kong and 2 more
- Volunteers
- 45 people
- Sponsor
- Precision BioSciences, Inc.
Chronic Hepatitis B
Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B
A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.
- Trial name
- NCT02881008
- Testing
- Entecavir, Myrcludex B
- Where
- 9 sites in Russia
- Volunteers
- 48 people
- Sponsor
- Hepatera Ltd.
Hepatitis B
Hepatitis B Challenge Dose in Adults (V232-059-10)
The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose…
- Trial name
- NCT01251276
- Testing
- Modified Process Hepatitis B Vaccine
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
- Trial name
- NCT00697749
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults
This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT05952596
- Testing
- DTaP-HepB-IPV-Hib vaccine
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- LG Chem