Clinical trials: Chronic Hepatitis B
Autoimmune Hepatitis
ADCC Mediated B-Cell dEpletion and BAFF-R Blockade
VAY736 dose testing; VAY736 efficacy and safety testing.
- Trial name
- AMBER (NCT03217422)
- Testing
- VAY736
- Where
- 28 sites in United States, Argentina and 8 more
- Volunteers
- 68 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis b
An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis b Who Have Received Nucleoside (Acid) Therapy
This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility.
- Trial name
- NCT04157257
- Testing
- TDF tablet, Entecavir Tablet, QL-007
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Chronic Hepatitis, Hepatitis B
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.
- Trial name
- QUASH2 (NCT00496158)
- Testing
- Clevudine, Adefovir
- Where
- 119 sites in United States, Argentina and 9 more
- Sponsor
- Pharmasset
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B.
- Trial name
- NCT01730508
- Testing
- Pegylated Interferon Alfa (Peginterferon Alfa)
- Where
- 88 sites in China
- Volunteers
- 978 people
- Sponsor
- Hoffmann-La Roche
HBV, Chronic HBV Infection
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive 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
- NCT02836249
- Testing
- TAF, TDF
- Where
- 25 sites in China
- Volunteers
- 181 people
- Sponsor
- Gilead Sciences
HBeAg Positive Chronic Hepatitis B
The Clinical Trial of the Anti Hepatitis B Placenta Transfer Factor Injection
Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.
- Trial name
- NCT02412319
- Testing
- Anti-HBV placenta transfer factor injection
- Volunteers
- 288 people
- Sponsor
- Shineway Pharmaceutical Co.,Ltd
Chronic Hepatitis B Virus Infection
A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
- Trial name
- NCT04971512
- Testing
- EDP-721, EDP-721 (Part 2), EDP-514
- Where
- New Zealand
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Chronic Hepatitis B Virus Infection
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV).
- Trial name
- NCT07389044
- Testing
- IB-001, Peginterferon Alfa-2A
- Where
- 5 sites in Hong Kong, Moldova and 2 more
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- IntegerBio
Chronic Hepatitis B
CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.
- Trial name
- CHARM (NCT00645736)
- Testing
- No intervention
- Where
- Australia
- Volunteers
- 788 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection.
- Trial name
- NCT00388674
- Testing
- entecavir, Other anti-HBV medication
- Where
- 290 sites in United States, Argentina and 22 more
- Volunteers
- 12,522 people
- Sponsor
- Bristol-Myers Squibb
HBV Infection
Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B
This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts.
- Trial name
- NCT07673068
- Testing
- TVAX-028, Adjuvant
- Volunteers
- 32 people
- Sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT00614471
- Testing
- Entecavir, peginterferon alfa-2a [Pegasys]
- Where
- 8 sites in China, Hong Kong
- Volunteers
- 219 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study
This open--label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with peginterferon alfa-2a in participants with chronic hepatitis B (CHB).
- Trial name
- NCT02201407
- Testing
- Peginterferon alfa-2a
- Where
- 6 sites in Serbia
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic…
- Trial name
- NCT00507507
- Testing
- Tenofovir DF, FTC
- Where
- 45 sites in United States, Australia and 9 more
- Volunteers
- 126 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants.
- Trial name
- NCT04271592
- Testing
- ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form
- Where
- New Zealand
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Chronic Hep B, Chronic Hepatitis b
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.
- Conditions
- Chronic Hep B, Chronic Hepatitis b, Chronic Hepatitis, HBV
- Trial name
- NCT06671093
- Testing
- Tune-401
- Where
- 3 sites in Hong Kong, Moldova and 1 more
- Volunteers
- 36 people
- Sponsor
- Tune Therapeutics, Inc.
Hepatitis B, HBV
Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor
An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B e antigen (HBeAg)-negative subjects with chronic HBV infection.
- Conditions
- Hepatitis B, HBV, Hepatitis B, Chronic
- Trial name
- NCT04023721
- Testing
- Inarigivir soproxil, Nucleoside/nucleotide (NUC) analogue inhibitors
- Where
- 7 sites in Canada, United Kingdom
- Volunteers
- 64 people
- Sponsor
- F-star Therapeutics, Inc.
Chronic Hepatitis b
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®)…
- Trial name
- NCT03847246
- Testing
- Baraclude® tablets,1.0 mg, Entecavir tablets,1.0 mg
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Hepatitis B Virus Infection
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT05970289
- Testing
- PEG-IFNα, BRII-835
- Where
- 28 sites in Australia, China and 3 more
- Volunteers
- 86 people
- Sponsor
- Brii Biosciences Limited
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.