Clinical trials: Hepatitis B Vaccine
Hepatitis B
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide…
- Trial name
- B-Clear (NCT04449029)
- Testing
- GSK3228836, Nucleos(t)ide therapy
- Where
- 121 sites in United States, Argentina and 20 more
- Volunteers
- 457 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic Hepatitis B
Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers
This is an open-label, randomized, multi-part study to evaluate the relative oral bioavailability of a tablet formulation of AL-3778 (formerly NVR 3-778) administered under fasted and fed conditions (Parts 1 and 2) and the…
- Conditions
- Hepatitis B, Chronic Hepatitis B, Viral Hepatitis B
- Trial name
- NCT03032536
- Testing
- AL-3778, Entecavir, Tenofovir disoproxil fumarate
- Where
- 2 sites in New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Hepatitis B, Hepatitis C
Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment…
- Trial name
- NCT01772121
- Where
- 19 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A Study of ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Doses in Healthy Volunteers, and Single and Multiple Doses in CHB Subjects
A randomized study of ALG-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in CHB subjects
- Trial name
- NCT05561530
- Testing
- ALG-125755
- Where
- 4 sites in Bulgaria, Moldova and 2 more
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine…
- Trial name
- NCT00440531
- Testing
- Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental), Comparator: ENGERIX-B™ (currently licensed product)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
- Trial name
- NCT01005407
- Testing
- Engerix-B
- Where
- 32 sites in United States, Canada
- Volunteers
- 2,452 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Hepatitis B, Chronic
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic…
- Trial name
- NCT02956850
- Testing
- RO7020531
- Where
- 18 sites in Bulgaria, Hong Kong and 6 more
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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.
Whole Cell Pertussis, Tetanus
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24…
- Conditions
- Whole Cell Pertussis, Tetanus, Hepatitis B, Diphtheria
- Trial name
- NCT00228917
- Testing
- Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, Mencevax-ACWY
- Where
- 2 sites in Philippines, Thailand
- Volunteers
- 798 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis
An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection.
- Conditions
- Hepatitis B, Hepatitis, Liver Diseases
- Trial name
- NCT03692897
- Testing
- All approved therapies for the treatment of Chronic Hepatitis B (CHB)
- Where
- 31 sites in United States, Canada
- Volunteers
- 1,708 people
- Sponsor
- Target PharmaSolutions, Inc.
Hepatitis B Infection, Congenital Malformation
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection.
- Conditions
- Hepatitis B Infection, Congenital Malformation, Birth Defect, Viremia
- Trial name
- NCT03476083
- Testing
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Where
- 7 sites in China
- Volunteers
- 280 people
- Sponsor
- New Discovery LLC
Hepatitis B
Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection
Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.
- Trial name
- NCT02738008
- Testing
- ARC-520 Injection, entecavir, tenofovir
- Where
- 6 sites in China, Germany and 1 more
- Volunteers
- 12 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
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 B
Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
- Trial name
- NCT00291954
- Testing
- HB-AS02V, HBVAXPRO vaccine
- Where
- 25 sites in Belgium, Czechia and 1 more
- Volunteers
- 257 people
- Sponsor
- Henogen
Chronic Hepatitis B
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB).
- Trial name
- NCT07876856
- Testing
- AHB-137, TVAX-008
- Volunteers
- 105 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Bacterial Infections, Virus Diseases
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
- Trial name
- NCT01340937
- Testing
- V419, PENTACEL™, Prevnar 13™
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.
- Trial name
- NCT01463683
- Testing
- 2XP HEPTAVAX™-II SC, 1XP HEPTAVAX™-II SC, 2XP HEPTAVAX™-II IM
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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