Clinical trials: Hepatitis B, Chronic
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.
Chronic Hepatitis b
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
- Trial name
- NCT05189288
- Testing
- D418 Tab., CKD-388 Tab.
- Where
- South Korea
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Chronic Viral Hepatitis B With Delta-agent
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with Chronic Viral Hepatitis B with Delta-agent
- Trial name
- NCT02888106
- Testing
- Myrcludex B, PEG IFN alfa-2a, Tenofovir
- Where
- 7 sites in Russia
- Volunteers
- 90 people
- Sponsor
- Hepatera Ltd.
Chronic Hepatitis B
Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients
This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks
- Trial name
- NCT04539652
- Testing
- Experimental
- Where
- South Korea
- Volunteers
- 78 people
- Sponsor
- Chong Kun Dang Pharmaceutical
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, Chronic
Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV
This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and…
- Trial name
- NCT05107778
- Testing
- ASC42 10mg, ASC42 15mg, ih PEG-IFN α-2a
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
Chronic Kidney Disease
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
- Trial name
- NCT00985426
- Testing
- HEPLISAV-B, Engerix-B
- Where
- United States
- Volunteers
- 521 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Hepatitis b
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection.
- Trial name
- HBV003 (NCT03038802)
- Testing
- Therapeutic hepatitis B vaccine, Commercial Hepatitis B vaccine
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Vaxine Pty Ltd
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.
Hepatitis B, Chronic
Therapeutic Safety and Efficacy of REP 9AC (REP 2055) in HBV or HCV Infected Patients
REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry activity against hepatitis C virus and entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection.
- Trial name
- NCT02646163
- Testing
- REP 2055
- Where
- Bangladesh
- Volunteers
- 8 people
- Sponsor
- Replicor Inc.
Hepatitis B, Chronic, Hepatitis D, Chronic
A Long Term Follow-up Study of Patients From the REP 301 Protocol
The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN).
- Trial name
- NCT02876419
- Where
- Moldova
- Volunteers
- 11 people
- Sponsor
- Replicor Inc.
Chronic Hepatitis B
Evaluation of Chronic HBV Patients w/Evidence of HBV Replication and Normal or Minimally Elevated Liver Transaminases.
To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological…
- Trial name
- NCT00263614
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B
This is a Phase4, multicenter, open-label, randomized study to demonstrate that the Tenolid Tab switching group is non-inferior to the virologic suppression effect compared to the Viread Tab continuous administration group and…
- Trial name
- NCT05282407
- Testing
- Tenofovir disoproxil 245mg, Tenofovir disoproxil fumarate 300mg
- Where
- South Korea
- Volunteers
- 118 people
- Sponsor
- Samjin Pharmaceutical Co., Ltd.
Hepatitis B, Chronic
Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB).
- Trial name
- NCT05867056
- Testing
- IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses, HBV HCC Module MAD
- Where
- 15 sites in United States, Australia and 7 more
- Sponsor
- Immunocore Ltd
Hepatitis B
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤…
- Trial name
- NCT00426712
- Testing
- 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen, Hepatitis B Vaccine (Recombinant)
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Dynavax Technologies Corporation
Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B
This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic…
- Trial name
- NCT07589400
- Testing
- ACT500 Tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepatitis B
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
- Trial name
- NCT00316719
- Testing
- LAM group, ADV group
- Volunteers
- 105 people
- Sponsor
- GlaxoSmithKline
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.
Chronic Hepatitis B
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
- Trial name
- NCT02862106
- Testing
- εPA-44
- Where
- 9 sites in China
- Volunteers
- 209 people
- Sponsor
- Chongqing Jiachen Biotechnology Ltd.
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.