Clinical trials: Hepatitis B, Chronic
Chronic Hepatitis B
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.
- Trial name
- NCT01817725
- Testing
- HBV vaccine (Engerix B)
- Where
- Taiwan
- Volunteers
- 20 people
- Sponsor
- Chang Gung Memorial Hospital
Chronic Hepatitis B
A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection
The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with…
- Trial name
- NCT04781647
- Testing
- ABI-H0731, ETV, Peg-IFNα
- Where
- 9 sites in China
- Volunteers
- 54 people
- Sponsor
- Assembly Biosciences
Hepatitis B
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo.
- Trial name
- NCT02797522
- Testing
- ARC-521 Injection, antihistamine, acetaminophen
- Where
- New Zealand
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01519921
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 7 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients
This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB.
- Trial name
- NCT00441974
- Testing
- adefovir dipivoxil
- Where
- 25 sites in China
- Volunteers
- 1,470 people
- Sponsor
- GlaxoSmithKline
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
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Lactic Acidosis
Lactic Acidosis During Entecavir(ETV)Treatment
The purpose of this study is to investigate whether entecavir treatment increases the incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase inhibitors (NRTI), lamivudine, and/or no NRTI…
- Trial name
- ETV (NCT01354652)
- Testing
- entecavir, lamivudine
- Volunteers
- 5 people
- Sponsor
- Asan Medical Center
Chronic Hepatitis B
Study of Telbivudine in Chronic Hepatitis B
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (<=300 copies/ml or 60IU/ml, undetectable by current polymerase…
- Trial name
- NCT00970216
- Testing
- Telbivudine
- Where
- Taiwan
- Volunteers
- 160 people
- Sponsor
- Chang Gung Memorial Hospital
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.
Liver Failure, Acute on Chronic
Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study
Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute deterioration of liver function, culminating in multiple organs failure and high short-term mortality.
- Trial name
- Ch-CANONIC (NCT02457637)
- Testing
- Standary therapy
- Where
- 16 sites in China
- Volunteers
- 2,600 people
- Sponsor
- Hai Li
Hepatitis E
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )
This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.
- Trial name
- NCT02964910
- Testing
- Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Where
- China
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis B, Chronic
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.
- Trial name
- NCT01475851
- Testing
- GSK548470 300 mg tablet
- Where
- 11 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in…
- Trial name
- NCT03576066
- Testing
- ABI-H0731, SOC NUC
- Where
- 21 sites in United States, Canada and 1 more
- Volunteers
- 73 people
- Sponsor
- Assembly Biosciences
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past.
- Trial name
- NCT00487747
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 23 sites in Russia
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV…
- Trial name
- NCT02791269
- Testing
- Peginterferon alfa-2a
- Where
- 6 sites in New Zealand
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already…
- Trial name
- NCT02726789
- Testing
- REP 2139-Ca, pegylated interferon, entecavir
- Volunteers
- 5 people
- Sponsor
- Replicor Inc.
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Chronic Hepatitis B
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently…
- Trial name
- NCT00307489
- Testing
- tenofovir DF, emtricitabine /tenofovir DF
- Where
- 28 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic…
- Trial name
- NCT02956850
- Testing
- RO7020531
- Where
- 18 sites in Bulgaria, Hong Kong and 6 more
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche