Clinical trials: Hepatitis B Virus
Chronic Hepatitis B, HBV (Hepatitis B Virus)
Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients
This study is an open-label, 2-Part (Single Ascending Dose [Part 1] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB).
- Trial name
- NCT06661148
- Testing
- EPI-003
- Where
- 4 sites in Australia, China and 1 more
- Volunteers
- 36 people
- Sponsor
- Epigenic Therapeutics, Inc
Hepatitis B
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.
- Trial name
- NCT01627340
- Testing
- Engerix™-B vaccine
- Where
- 22 sites in United States, Australia and 2 more
- Volunteers
- 667 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Chronic Hepatitis b
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection.
- Trial name
- HBV003 (NCT03038802)
- Testing
- Therapeutic hepatitis B vaccine, Commercial Hepatitis B vaccine
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Vaxine Pty Ltd
Hepatitis B, Chronic
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B.
- Trial name
- NCT00962975
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 6 sites in United States, New Zealand and 2 more
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.
- Trial name
- NCT02588937
- Testing
- EntecaBell ODT. 0.5mg, Baraclude Tab. 0.5mg
- Where
- 9 sites in South Korea
- Volunteers
- 76 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Chronic Hepatitis b
Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets
A Randomized, Double-blind, Placebo-controlled and Multicenter Phase Ⅱ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia.
- Trial name
- NCT05637541
- Testing
- GST-HG141
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
Hepatitis B, Chronic Hep B
A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B
This study is a multicenter, open-label, phase II clinical study in subjects with chronic hepatitis B (CHB), to characterize the safety, tolerability, pharmacokinetic profile and preliminary anti-hepatitis B virus (HBV) efficacy…
- Conditions
- Hepatitis B, Chronic Hep B, HBV
- Trial name
- NCT04568265
- Testing
- APG-1387, Entecavir 0.5 mg
- Where
- 4 sites in China
- Volunteers
- 122 people
- Sponsor
- Ascentage Pharma Group Inc.
Hepatitis C
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection
- Trial name
- D-LITE (NCT01795911)
- Testing
- Pegylated Interferon Lambda, Ribasphere, Daclatasvir
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B Virus
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.
- Trial name
- NCT03294798
- Testing
- Human Serum Albumin/interferon alpha2b fusion protein, Pegasys
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Tianjin SinoBiotech Ltd.
Hepatitis B
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.
- Trial name
- NCT01777295
- Testing
- Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A., EngerixTM-B
- Where
- Belgium
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).
- Trial name
- NCT03365947
- Testing
- ARO-HBV, Sterile Normal Saline (0.9% NaCl), JNJ-56136379
- Where
- 7 sites in Australia, Hong Kong and 1 more
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
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.
Hepatitis B
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
- Trial name
- NCT00383227
- Testing
- Hepatitis B adjuvanted vaccine
- Volunteers
- 165 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis B Infection
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare…
- Trial name
- NCT06368466
- Testing
- iStatis HBsAg Test
- Where
- Australia
- Volunteers
- 175 people
- Sponsor
- bioLytical Laboratories
Diphtheria, Tetanus
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02817451
- Testing
- Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
- Where
- South Africa
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics…
- Trial name
- NCT05763576
- Testing
- RO7565020, Nucleos(t)ide analogue (NUC) treatment
- Where
- 9 sites in United States, Hong Kong and 5 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
- Trial name
- NCT05808374
- Testing
- HRS-5635
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Hepatitis B
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.
- Trial name
- NCT00343915
- Testing
- Engerix™-B (thiomersal-free) 20µg, 10 μg Engerix™-B (preservative-free)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine.
- Trial name
- NCT00414050
- Testing
- Modified Process Hepatitis B Vaccine (Experimental), Hepatitis B Vaccine (Recombinant)
- Volunteers
- 1,718 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC