Clinical trials: Hepatitis B, Chronic
Chronic Hepatitis B
A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers
This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as…
- Trial name
- NCT05273775
- Testing
- HRS5091 Tablets, Midazolam Maleate Tablets, Warfarin Sodium Tablets
- Where
- China
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B
This randomized controlled trial is designed to evaluate safety, effectiveness and pharmacokinetic-pharmacodynamic (PK/PD) relationships associated with three different Nitazoxanide (NTZ) treatment regimens added to Tenofovir…
- Trial name
- NCT03905655
- Testing
- Nitazoxanide
- Where
- Singapore
- Volunteers
- 51 people
- Sponsor
- Romark Laboratories L.C.
Compensated Chronic Hepatitis B
Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in…
- Trial name
- NCT00877149
- Testing
- telbivudine/LDT600
- Where
- 4 sites in China
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B, Chronic
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV).
- Trial name
- NCT01095835
- Testing
- Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg, Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg, Lamivudine (LAM)
- Where
- 22 sites in Italy
- Volunteers
- 131 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir
This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect when administered to non-treated…
- Trial name
- NCT04365933
- Testing
- EYP001a, Entecavir, Pegylated interferon alpha2a
- Where
- 6 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 20 people
- Sponsor
- Enyo Pharma
Hepatitis B, Chronic
Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation
The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus…
- Trial name
- NCT00895713
- Testing
- intramuscular hepatitis B virus immune globulin
- Where
- 2 sites in Italy
- Volunteers
- 18 people
- Sponsor
- Instituto Grifols, S.A.
Hepatitis B, Chronic
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to…
- Trial name
- NCT00661076
- Testing
- adefovir dipivoxil, peginterferon alfa-2a [Pegasys]
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 10 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B in Adults and Paediatric Patients
Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose, fully replicate, bioequivalence study in normal, healthy…
- Trial name
- NCT06592300
- Testing
- Tenofovir Alafenamide Film coated Tablet, Vemlidy® film-coated tablets
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Hepatitis B, Liver Transplantation
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver…
- Trial name
- NCT00722332
- Testing
- HepaGam B
- Where
- 16 sites in United States, Canada
- Volunteers
- 9 people
- Sponsor
- Cangene Corporation
HBeAg-negative Chronic Hepatitis B
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative 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
- NCT01940341
- Testing
- TAF, TDF
- Where
- 105 sites in United States, Australia and 15 more
- Volunteers
- 426 people
- Sponsor
- Gilead Sciences
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
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic…
- Trial name
- NCT01651403
- Testing
- Tenofovir DF
- Where
- 21 sites in United States, India and 3 more
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China
To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination…
- Trial name
- EVOLVE (NCT01726439)
- Where
- 54 sites in China
- Volunteers
- 3,434 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)
- Trial name
- NCT03577171
- Testing
- ABI-H0731, SOC ETV
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 25 people
- Sponsor
- Assembly Biosciences
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 Hepatitis b
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chronic Hepatitis B
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
- Trial name
- NCT05828745
- Testing
- CB06-036
- Where
- 2 sites in China, New Zealand
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Chronic Hepatitis B
REP 2139-Mg and REP 2165-Mg Combination Therapy in Chronic Hepatitis B Infection
NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients.
- Trial name
- NCT02565719
- Testing
- REP 2139-Mg, Pegasys, Viread
- Where
- 3 sites in Moldova
- Volunteers
- 40 people
- Sponsor
- Replicor Inc.
Chronic Hepatitis B
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
The 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 HBeAg-positive chronic hepatitis B.
- Trial name
- NCT00116805
- Testing
- TDF, ADV, FTC/TDF
- Where
- 87 sites in United States, Australia and 13 more
- Volunteers
- 266 people
- Sponsor
- Gilead Sciences
End Stage Renal Disease on Hemodialysis (Diagnosis)
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
- Trial name
- NCT03934736
- Testing
- HEPLISAV-B®
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Dynavax Technologies Corporation