Clinical trials: HBV
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.
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
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
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
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
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
Chronic Hepatitis B Virus Infection
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV).
- Trial name
- NCT07389044
- Testing
- IB-001, Peginterferon Alfa-2A
- Where
- 5 sites in Hong Kong, Moldova and 2 more
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- IntegerBio
Hepatitis B
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course…
- Trial name
- NCT00880477
- Testing
- DTPa-HBV-IPV/Hib vaccine, DTPa-IPV/Hib vaccine, EngerixTM-B
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Pertussis
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H.
- Conditions
- Diphtheria, Pertussis, Polio, Hepatitis B
- Trial name
- NCT00362427
- Testing
- Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
- Where
- 8 sites in Canada
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Acellular Pertussis, Diphtheria
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib…
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b
- Trial name
- NCT00627458
- Testing
- Infanrix Hexa
- Where
- 6 sites in Finland
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA
Primary objective: To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a…
- Trial name
- NCT00693186
- Testing
- HBVaxPRO® 5 µg / 0.5 mL, Engerix B® 10 µg / 0.5 mL
- Where
- 5 sites in Italy
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
- Trial name
- NCT00697853
- Testing
- Engerix™-B, HBV-MPL vaccine 208129
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects.
- Trial name
- NCT05569941
- Testing
- ABI-4334 Tablet
- Where
- New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Hepatitis B
Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal
Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in sub-Saharan Africa (SSA). Prior to the introduction of the hepatitis B vaccine, main modes of transmission in SSA were perinatal transmission…
- Trial name
- NeoVac2S (NCT03829735)
- Testing
- Human biological samples
- Volunteers
- healthy volunteers welcome
- Sponsor
- Institut Pasteur
Hepatitis B
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg…
- Trial name
- NCT01427868
- Testing
- LB80380 maleate salt, LB80380 free base
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences