Clinical trials: Hepatitis B Virus
Hepatitis B, Chronic
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).
- Trial name
- ASPIRE-201 (NCT07370207)
- Testing
- AHB-137
- Where
- 10 sites in Australia, China and 5 more
- Volunteers
- 84 people
- Sponsor
- AusperBio Therapeutics Inc.
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
A Study of RBD1016 in CHB Participants
This study is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection on NAs background treatment in CHB participants.
- Trial name
- NCT05961098
- Testing
- RBD1016
- Where
- 4 sites in China, Sweden
- Volunteers
- 48 people
- Sponsor
- Suzhou Ribo Life Science Co. Ltd.
HBV, Chronic HBV Infection
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis…
- Trial name
- NCT02836236
- Testing
- TAF, TDF
- Where
- 29 sites in China
- Volunteers
- 155 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients
This study is an open label, dose escalation study using the classical 3+3 design to determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA therapeutic vaccine administered by Electroporation…
- Trial name
- NCT01641536
- Testing
- HB-110
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Genexine, Inc.
Hepatitis B
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2…
- Trial name
- NCT03426618
- Testing
- Non-interventional
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50%…
- Trial name
- NCT06707922
- Testing
- Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
- Where
- 30 sites in China
- Volunteers
- 350 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
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.
Chronic Hepatitis B
A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B
This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).
- Trial name
- NCT01671787
- Testing
- GS-7340, Tenofovir disoproxil fumarate
- Where
- 19 sites in United States, Australia and 3 more
- Volunteers
- 51 people
- Sponsor
- Gilead Sciences
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.
- Trial name
- NCT03491553
- Testing
- Selgantolimod, Hepatitis B virus (HBV) OAV Therapy
- Where
- 2 sites in United States, New Zealand
- Volunteers
- 48 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
- Trial name
- NCT01026610
- Testing
- LB80380 90 mg, LB80380 150 mg, entecavir 0.5 mg
- Where
- 10 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
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
Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal
Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in sub-Saharan Africa (SSA). Prior to the introduction of the hepatitis B vaccine, main modes of transmission in SSA were perinatal transmission…
- Trial name
- NeoVac2S (NCT03829735)
- Testing
- Human biological samples
- Volunteers
- healthy volunteers welcome
- Sponsor
- Institut Pasteur
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 B
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B
This 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 pre-core mutant chronic hepatitis B.
- Trial name
- NCT00117676
- Testing
- TDF, ADV, FTC/TDF
- Where
- 80 sites in United States, Australia and 13 more
- Volunteers
- 382 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus…
- Trial name
- NCT00962871
- Testing
- peginterferon alfa-2a [Pegasys], tenofovir
- Where
- 6 sites in United States, New Zealand and 2 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination…
- Trial name
- PEG-Tα1 (NCT02366247)
- Testing
- PEG-Tα1, Adefovir
- Where
- 32 sites in China
- Volunteers
- 463 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
Hepatitis
Twinrix Pregnancy Registry
The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information…
- Trial name
- NCT03619590
- Testing
- Data Collection
- Volunteers
- 245 people
- Sponsor
- GlaxoSmithKline