Clinical trials: Hepatitis b Virus
Hepatitis B
Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B
The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months
- Trial name
- NCT00697840
- Testing
- Engerix™-B, HBV-MPL 208129, Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation
- Where
- Austria
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response
GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine…
- Trial name
- NCT00197158
- Testing
- Hepatitis B vaccine
- Where
- Belgium
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2…
- Trial name
- NCT03426618
- Testing
- Non-interventional
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in…
- Trial name
- NCT00507689
- Testing
- FTC/TDF, Hepatitis B Immunoglobulin (HBIg)
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B
This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B.
- Trial name
- NCT00117676
- Testing
- TDF, ADV, FTC/TDF
- Where
- 80 sites in United States, Australia and 13 more
- Volunteers
- 382 people
- Sponsor
- Gilead Sciences
Hepatitis A Virus
Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein…
- Trial name
- NCT00289913
- Testing
- Comparator: VAQTA™, Comparator: Infanrix™, Comparator: PedvaxHIB™
- Volunteers
- 1,274 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Infectious Disease
A Study in Healthy Volunteers
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers.
- Conditions
- Hepatitis B, Infectious Disease, Liver Diseases
- Trial name
- NCT03596697
- Testing
- CRV431, TDF
- Where
- 3 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Liver Cirrhosis
Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.
- Trial name
- NCT05106972
- Testing
- UC-MSC infusion
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
Multicenter Performance Study of TriQuik Invitro Diagnostic Device
This prospective and historical clinical study is designed to test the performance of the Genlantis TriQuik test kit (Cassette). The primary goal is to establish the sensitivity and specificity (i.e.
- Trial name
- NCT05293821
- Testing
- TriQuik IVD
- Volunteers
- 200 people
- Sponsor
- Genlantis Diagnostics
Hepatitis B, Chronic
A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)
This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg] positive or negative) who have not previously been…
- Trial name
- NCT01641926
- Testing
- PEG-Intron™, PEGASYS™
- Volunteers
- 402 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Chronic
Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.
- Trial name
- Nabi-HB-SC (NCT00800787)
- Testing
- Nabi-HB
- Sponsor
- Biotest Pharmaceuticals Corporation
Hepatitis B
Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against…
- Trial name
- NCT02697474
- Testing
- Euvax B®: Hepatitis B vaccine
- Where
- 2 sites in Thailand
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
HIV1 Infection, HIV 2 Infection
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples…
- Conditions
- HIV1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07569913
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- Australia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Diphtheria, Hepatitis B
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
- Conditions
- Diphtheria, Hepatitis B, Whole Cell Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00317135
- Testing
- Tritanrix-HepB/Meningitec conjugate vaccine, Tritanrix/Hiberix vaccine
- Where
- Philippines
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune…
- Trial name
- NCT01333813
- Testing
- Engerix-B™ Kinder
- Where
- 12 sites in Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection
The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d.
- Trial name
- NCT02058108
- Testing
- Telbivudine
- Where
- 29 sites in Bulgaria, Greece and 5 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis B
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
Objectives: Primary Objective: To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b…
- Trial name
- NCT02355951
- Testing
- blood draw
- Where
- 11 sites in Canada, France and 1 more
- Volunteers
- 166 people
- Sponsor
- Transgene
Haemophilus Influenzae Type b, Diphtheria
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b.
- Conditions
- Haemophilus Influenzae Type b, Diphtheria, Tetanus, Hepatitis B
- Trial name
- NCT00316680
- Testing
- Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
- Where
- Dominican Republic
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.