Clinical trials: Chronic HBV Infection (HBeAg Negative)
Chronic Hepatitis B
Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B
This is a phase IV, 2-year, multi-center, single arm and open-label study, evaluating the efficacy and safety with using local manufactured adefovir dipivoxil in Chinese subjects with HBeAg negative chronic hepatitis B
- Trial name
- NCT00324961
- Testing
- adefovir dipivoxil tablets
- Where
- 18 sites in China
- Volunteers
- 533 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (only in Participants with Chronic HBV Infection)
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized…
- Trial name
- NCT06744686
- Testing
- HT-102
- Where
- 7 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Suzhou HepaThera Biotech Co., Ltd.
Chronic Hepatitis B
Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as sustained viral response after treatment.
- Trial name
- NCT02365402
- Testing
- Entecavir
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Beijing Ditan Hospital
Hepatitis B, Chronic
Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Negative Chronic Hepatitis B
Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from satisfactory.
- Trial name
- NCT00917761
- Testing
- Entecavir and peginterferon (Pegasys) (52 weeks), Peginterferon (Pegasys) (96 weeks), Peginterferon (Pegasys) (48 weeks)
- Where
- 6 sites in Taiwan
- Volunteers
- 300 people
- Sponsor
- National Taiwan University Hospital
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.
Hepatitis B
48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to investigate whether in patients with chronic HBeAg-negative hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV DNA <10E4 copies/ml and normal ALT 24 weeks…
- Trial name
- NCT00114361
- Testing
- Ribavirin, Peginterferon alpha 2a
- Where
- Netherlands
- Volunteers
- 138 people
- Sponsor
- Foundation for Liver Research
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
Hepatitis B
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
Patients with chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
- Trial name
- NCT02604199
- Testing
- ARC-520 Injection, entecavir, tenofovir
- Where
- 16 sites in China, Germany and 1 more
- Volunteers
- 58 people
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Hepatitis B
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated…
- Trial name
- NCT02838810
- Testing
- peginterferon alfa, Nucleoside analogues
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Chronic Hepatitis B
Follow Up of Patients Chronic Hepatitis B (CHB) Treated With Sebivo Using the 13C Methacetin Breath Test
Patients with HBeAg negative chronic HBV and evidence of hepatic disease (elevated liver enzymes or evidence of cirrhosis) who have significant viremia are treated with anti HBV therapy.
- Trial name
- NCT01204827
- Testing
- 13C Methacetin Breath Test (BreathID)
- Where
- Israel
- Sponsor
- Hadassah Medical Organization
Hepatitis B, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B…
- Trial name
- NCT01706575
- Testing
- Pegylated Interferon (Peginterferon) Alfa-2a, Nucleos(t)ide Analogues (NA)
- Where
- 27 sites in Italy
- Volunteers
- 76 people
- Sponsor
- Hoffmann-La Roche
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
Hepatitis B Surface Antigen(HBsAg) Loss in Chronic Hepatitis B Patients With Low Viral Load
Rationale: Worldwide, approximately 400 million people are chronically infected with hepatitis B virus (HBV). Chronic HBV infection increases the risk of developing cirrhosis, hepatic decompensation and hepatocellular carcinoma…
- Trial name
- LVL (NCT00973219)
- Testing
- Peg-Interferon alfa 2a + Adefovir dipivoxil, Peg-Interferon alfa 2a + Tenofovir disoproxil fumarate
- Where
- Netherlands
- Volunteers
- 151 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Chronic Hepatitis B
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with…
- Trial name
- PADD-ON (NCT01524679)
- Testing
- Pegylated interferon alfa-2a plus nucleos(t)ide(s)
- Where
- 24 sites in Germany
- Volunteers
- 170 people
- Sponsor
- Johannes Gutenberg University Mainz
Hepatitis B, Chronic
A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)
This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg] positive or negative) who have not previously been…
- Trial name
- NCT01641926
- Testing
- PEG-Intron™, PEGASYS™
- Volunteers
- 402 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable…
- Trial name
- NCT00393484
- Testing
- Entecavir, Lamivudine
- Where
- 15 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B
Multicenter, Prospective Open-label Single Arm Trial Chronic hepatitis B male and female adults on antiviral treatment for hepatitis B, without cirrhosis who are currently HBV DNA (-) and HBeAg (-) To evaluate the safety and…
- Trial name
- ADAPT (NCT04782375)
- Testing
- Stop group
- Where
- 4 sites in South Korea
- Volunteers
- 140 people
- Sponsor
- Asan Medical Center
Hepatitis B, Chronic
A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137…
- Trial name
- NCT06115993
- Testing
- AHB-137 injection
- Where
- 3 sites in China
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B
The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled.
- Trial name
- NCT02893124
- Testing
- peginterferon alfa
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Chronic Hepatitis B
Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection
The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d.
- Trial name
- NCT02058108
- Testing
- Telbivudine
- Where
- 29 sites in Bulgaria, Greece and 5 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals