Clinical trials: Chronic Hepatitis, B Virus
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B.
- Trial name
- NCT00435825
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 55 sites in United States, Australia and 11 more
- Volunteers
- 551 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B Virus (HBV)
Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients
A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.
- Trial name
- NCT04189276
- Testing
- ETV/TDF+T101 No.1, ETV/TDF+T101 No.2, ETV or TDF
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Tasly Tianjin Biopharmaceutical Co., Ltd.
Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with…
- Trial name
- NCT07606950
- Testing
- HRS-5635 Injection
- Where
- China
- Volunteers
- 540 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
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.
Chronic HBV Infection
A Long-term Observational Study in Participants Who Have Received PBGENE-HBV
Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.
- Trial name
- ELIMINATE-B (NCT07254208)
- Testing
- PBGENE-HBV
- Where
- 4 sites in United States, Hong Kong and 2 more
- Volunteers
- 45 people
- Sponsor
- Precision BioSciences, Inc.
Hepatitis B Virus-Related Hepatocellular Carcinoma
The Follow-up Study of Chronic Hepatitis B Patients With Liver Cirrhosis Receiving Anti-HBV Therapy
Hepatitis B virus (HBV) infection is a global health problem, especially in the endemic area like Taiwan, where there are more than 3 million chronic hepatitis B carriers.
- Trial name
- CTEAM (NCT01957618)
- Where
- Taiwan
- Volunteers
- 1,500 people
- Sponsor
- National Taiwan University Hospital
Chronic Hepatitis B
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with…
- Trial name
- NCT02979613
- Testing
- TAF, TDF
- Where
- 39 sites in United States, Canada and 6 more
- Volunteers
- 490 people
- Sponsor
- Gilead Sciences
Acute Liver Failure, Acute Liver Injury
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: safety and tolerability; metabolism of the compound to glutamine and…
- Trial name
- STOP-ALF (NCT01548690)
- Testing
- Ornithine Phenylacetate
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- William Lee
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.
Hepatitis B
Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy…
- Trial name
- NCT05330455
- Testing
- GSK3965193, Bepirovirsen
- Where
- 14 sites in Canada, France and 4 more
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Healthy
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication.
- Trial name
- NCT04297917
- Testing
- ChAdOx1-HBV
- Where
- 4 sites in United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Barinthus Biotherapeutics
Hepatitis b Virus, Hepatitis B
HepB mAb19 in Individuals With Chronic Hepatitis B Infection
This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB…
- Trial name
- NCT05856890
- Testing
- HepB mAb19, Sterile Saline
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Rockefeller University
HBV, Hepatitis B
Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients
A single center, open-label, study to evaluate the intra-hepatic effect of inarigivir dose per day and three times per week on immune response and viral markers in virally suppressed patients with chronic hepatitis B infection
- Conditions
- HBV, Hepatitis B, Hepatitis B, Chronic
- Trial name
- NCT03932513
- Testing
- inarigivir soproxil
- Where
- Singapore
- Volunteers
- 8 people
- Sponsor
- F-star Therapeutics, Inc.
Hepatitis B, Chronic
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and…
- Trial name
- NCT00927082
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 31 sites in Australia, Brazil and 8 more
- Volunteers
- 383 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B， Chronic
"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu
Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death.
- Trial name
- NCT03097952
- Where
- 6 sites in China
- Volunteers
- 20,000 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Chronic Hepatitis B
Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144.
- Trial name
- NCT02258581
- Testing
- GS-4774, GS-9620, Tenofovir disoproxil fumarate (TDF)
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 241 people
- Sponsor
- Gilead Sciences
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
Chronic Hepatitis B
Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral…
- Trial name
- NCT02387684
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Beijing Ditan Hospital
Chronic Hepatitis B
Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB
Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients.
- Trial name
- PEGON (NCT01532843)
- Testing
- PegIFN alfa-2b
- Where
- 4 sites in China, Netherlands
- Volunteers
- 82 people
- Sponsor
- Foundation for Liver Research
Liver Cirrhosis
Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis
The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis.
- Trial name
- NCT01223664
- Testing
- Allogenic bone marrow stem cells transplantation, Conserved therapy
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-sen University
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