Clinical trials: Hepatitis B Infections
Hepatitis B, Acellular Pertussis
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month…
- Conditions
- Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria
- Trial name
- NCT01457560
- Testing
- DTPa-HBV-IPV/Hib (Infanrix hexa™), OPV
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
GLS4/RTV and TAF Drug-drug Interaction
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
- Trial name
- NCT04551261
- Testing
- GLS4, RTV, TAF
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatitis B, Chronic
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg)…
- Trial name
- NCT03125213
- Testing
- AL-3778, Peginterferon Alfa-2A
- Sponsor
- Alios Biopharma Inc.
Hepatitis B, Chronic
Lamivudine and Adefovir Dipivoxil Fixed Dose Combination
This is a phase I study being conducted to support the clinical development program of a FDC product of the nucleoside analogue lamivudine and the nucleotide analogue adefovir dipivoxil.
- Trial name
- NCT01353742
- Testing
- Lamivudine, Adefovir dipivoxil, Fixed dose combination (Lamivudine and Adefovir dipivoxil)
- Where
- Hong Kong
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
- Trial name
- NCT00697853
- Testing
- Engerix™-B, HBV-MPL vaccine 208129
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HBeAg-positive Chronic Hepatitis B
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
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
- NCT01940471
- Testing
- TAF, TDF
- Where
- 160 sites in United States, Australia and 17 more
- Volunteers
- 875 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment.
- Trial name
- NCT02174276
- Testing
- Tenofovir disoproxil fumarate, GS-4774
- Where
- 33 sites in United States, Canada and 4 more
- Volunteers
- 195 people
- Sponsor
- Gilead Sciences
Hepatitis B
A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant
Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver.
- Trial name
- ZEUS (NCT01856413)
- Testing
- Zutectra
- Where
- 16 sites in France, Italy and 2 more
- Volunteers
- 49 people
- Sponsor
- Biotest
Hepatocellular Carcinoma
Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in…
- Trial name
- SAFE-T-HBV (NCT04745403)
- Testing
- mRNA HBV/TCR T-cells
- Where
- Singapore
- Volunteers
- 10 people
- Sponsor
- Lion TCR Pte. Ltd.
Chronic Hepatitis b
A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA
This is a randomized, open-label, positive-control, dose-escalation Phase 1b trial in 60 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration…
- Trial name
- QL-007 (NCT03770624)
- Testing
- QL-007 tablet, TDF
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hepatitis B
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
- Trial name
- NCT01513850
- Testing
- Hepabulin IV
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- SK Chemicals 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
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
Chronic Hepatitis B
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931.
- Trial name
- NCT03038113
- Testing
- RO7062931, Immune Modulator
- Where
- 19 sites in Australia, Hong Kong and 5 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus surface antigen (HBsAg) loss in participants…
- Trial name
- B-Together (NCT04676724)
- Testing
- GSK3228836, PegIFN, NA therapy
- Where
- 49 sites in United States, Canada and 9 more
- Volunteers
- 108 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients
The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.
- Trial name
- NCT01326546
- Testing
- Therapeutic HBV vaccine, entecavir
- Where
- 15 sites in China
- Volunteers
- 378 people
- Sponsor
- Chongqing Jiachen Biotechnology Ltd.
Chronic Hepatitis B
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.
- Trial name
- NCT00037622
- Testing
- ACH-126, 443 (beta-L-Fd4C)
- Volunteers
- 100 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Hepatitis B
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
This study is A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HT-101 injection combined with HT-102 injection in patients with chronic hepatitis B.
- Trial name
- NCT07245953
- Testing
- HT-101, HT-102
- Where
- 12 sites in China
- Volunteers
- 60 people
- Sponsor
- Suzhou HepaThera Biotech Co., Ltd.
Infections, Meningococcal
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the…
- Trial name
- NCT00317109
- Testing
- Tritanrix™- HepB, Hiberix™, Mencevax™ ACW
- Where
- 3 sites in South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis, Diphtheria
Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar…
- Conditions
- Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT02096263
- Testing
- Infanrix hexa, Pediarix, ActHIB
- Where
- 43 sites in United States
- Volunteers
- 585 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline