Clinical trials: Chronic Hepatitis B Infections
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
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults.
- Trial name
- Chinese PAC (NCT00781105)
- Testing
- Telbivudine
- Where
- China
- Volunteers
- 2,200 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B Virus, HBV
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.
- Trial name
- NCT01438424
- Testing
- Entecavir, Lamivudine
- Volunteers
- 1,053 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis b
Biomarkers Guided Stopping NAs Treatment
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already…
- Trial name
- NCT04519359
- Testing
- Stop NAs therapy
- Where
- 5 sites in China
- Volunteers
- 195 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Chronic Hepatitis b
A Study to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for Chronic Hepatitis B Virus Infection, in Healthy Adults
The purpose of this first time in humans trial is to evaluate the safety, reactogenicity and immunogenicity of repeated administrations of AVX70371 in healthy participants.
- Trial name
- RUBY (NCT06989788)
- Testing
- AVX70371
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstriVax Therapeutics
Hepatitis C, Chronic
Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection
Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made…
- Trial name
- EMERGE (NCT01001754)
- Testing
- PEG-rIL-29, Peginterferon alfa-2a, Ribavirin
- Where
- 79 sites in United States, Australia and 9 more
- Volunteers
- 600 people
- Sponsor
- ZymoGenetics
Hepatitis B, Chronic
A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with…
- Trial name
- NCT05484466
- Testing
- ZM-H1505R, Baraclude
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Hepatitis B, Cirrhosis, Liver
Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.
- Conditions
- Hepatitis B, Cirrhosis, Liver, Chronic Liver Disease
- Trial name
- NCT04588077
- Testing
- Heplisav-B Injectable Product, 2-dose regimen, Heplisav-B Injectable Product, 3-dose regimen
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Mercy Medical Center
Chronic Hepatitis B
A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B
This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.
- Trial name
- NCT07635186
- Testing
- AHB-137
- Where
- 34 sites in China
- Volunteers
- 320 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Hepatitis B, HBV
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules.
- Trial name
- NCT01590641
- Testing
- Single Ascending Dose (SAD) Cohorts GS-9620, Multiple Ascending Dose (MAD) Cohorts
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 49 people
- Sponsor
- Gilead Sciences
Non-alcoholic Fatty Liver Disease, Renal Function Impairment
Analysis of Renal Impairment Characteristics and High-Risk Factors in Chronic Hepatitis B Patients on Long-Term Oral Nucleos(t)Ide Analogues
This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included.
- Trial name
- NCT07730905
- Testing
- Long-term oral nucleos(t)ide analogs antiviral therapy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Foshan Hospital of Traditional Chinese Medicine
Chronic Hepatitis B
Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Chronic HBV Infection
This study is a retrospective study. Enrollment study. Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV…
- Trial name
- NCT04032275
- Testing
- Chronic hepatitis B infection
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Beijing Ditan Hospital
Liver Failure
The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF).
- Trial name
- NCT01254994
- Testing
- entecavir, Traditional comprehensive medical treatment
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Sun Yat-sen University
Chronic Hepatitis b
Off-therapy Response After Stopping Entecavir or Tenofovir
Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are current recommended first-line antiviral therapies for chronic hepatitis B (CHB).
- Trial name
- NCT03042481
- Where
- Taiwan
- Volunteers
- 400 people
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Hepatitis B
To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B
To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who have achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) <200 for last 3-6 month) with NA's can result in…
- Trial name
- RC14/055 (NCT02982837)
- Testing
- PEG-IFN & Nucleos(t)tide analogues, Nucleos(t)tide analogues
- Where
- 3 sites in Saudi Arabia
- Volunteers
- 214 people
- Sponsor
- King Abdullah International Medical Research Center
Tenofovir Disoproxil Fumarate, Renal Function Disorder
Effect of Tenofovir (TDF) on Renal Function in Patients With Chronic Hepatitis B
Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients with Chronic Hepatitis B Over a Five-Year Period
- Conditions
- Tenofovir Disoproxil Fumarate, Renal Function Disorder, Chronic HBV Infection
- Trial name
- NCT06896630
- Testing
- Tenofovir Disoproxil Fumarate (TDF)
- Where
- Egypt
- Volunteers
- 172 people
- Sponsor
- Assiut University
Hepatitis B, Chronic
A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253
This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study.
- Trial name
- NCT01697501
- Testing
- Interleukin 28B testing
- Where
- 12 sites in Italy
- Volunteers
- 88 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis b
A Study of LP-128 Capsules in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects
- Trial name
- NCT05130567
- Testing
- LP-128 capsules
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Guangzhou Lupeng Pharmaceutical Company 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
Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.
- Trial name
- NCT03792919
- Testing
- Stop current treatment (anti-HBV neucleos(t)ides), Keep current treatment (anti-HBV neucleos(t)ides)
- Where
- Hong Kong
- Volunteers
- 2,000 people
- Sponsor
- Humanity & Health Medical Group Limited