Clinical trials: Viral Hepatitis B
Chronic Hepatitis B
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic…
- Trial name
- NCT01997944
- Testing
- Human Serum ALbumin/interferon alpha2a, Pegasys
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Beijing Bio-Fortune Ltd.
Hepatitis B
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged…
- Trial name
- NCT00697775
- Testing
- HBV-MPL vaccine Formulation A, HBV-MPL vaccine Formulation B, Engerix™-B
- Where
- Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Liver Transplantation
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver…
- Trial name
- NCT01131065
- Testing
- Hepatitis B immune globulin
- Where
- 4 sites in Italy
- Volunteers
- 15 people
- Sponsor
- Instituto Grifols, S.A.
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 Virus (HBV)
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT00734162
- Testing
- Tenofovir disoproxil fumarate (TDF)
- Where
- 21 sites in United States, Bulgaria and 5 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
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
Chronic Hepatitis B
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial.
- Trial name
- NCT00467545
- Testing
- telbivudine
- Where
- 6 sites in South Korea
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B Virus Infection
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.
- Trial name
- NCT07024641
- Testing
- GIGA-2339
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 48 people
- Sponsor
- GigaGen, Inc.
Hepatitis B
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B.
- Trial name
- NCT00697554
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
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
Hepatitis B, Chronic
A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed
The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular injection in nucleos(t)ide analogs (NA)-treated…
- Trial name
- NCT03463369
- Testing
- JNJ-64300535, Nucleos(t)ide Analogs (NA)
- Where
- 14 sites in Belgium, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Janssen Sciences Ireland UC
Chronic Hepatitis B Infection
A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
This is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001.
- Trial name
- NCT07059403
- Testing
- SN2001
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chimivac INC
Healthy Volunteers, Hepatitis B, Chronic
A Multiple-dose Study in Chinese Subjects to Evaluate Safety,Tolerability,PK and PD of ZM-H1505R
This phase Ib study included two parts in which Part I was to evaluate the safety and bridge for PK among healthy Chinese subjects and Part II were about study among Chinese chronic hepatitis B virus-infected patients.
- Trial name
- NCT05470829
- Testing
- ZM-H1505R
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Hepatitis B Virus Antibody Booster Program
- Trial name
- NCT01311674
- Testing
- hepatitis B vaccine
- Where
- 2 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Hepatitis B
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.
- Trial name
- NCT00362674
- Where
- 27 sites in South Korea
- Sponsor
- Bukwang Pharmaceutical
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.
Tetanus, Hepatitis B
Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted…
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis
- Trial name
- NCT00197275
- Testing
- Hib-MenAC mixed with Tritanrix™-HepB
- Where
- 3 sites in Thailand
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection
This study is a prospective, open-label, multicenter long-term follow-up study to evaluate the durability of virologic response in subjects with chronic hepatitis B previously treated with AHB-137 injection.
- Trial name
- NCT07146100
- Where
- 37 sites in China
- Volunteers
- 200 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Hepatitis B, Liver Transplantation
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection.
- Trial name
- NCT00228592
- Testing
- HepeX-B, Hepatitis B Immune Globulin (HBIg)
- Where
- 20 sites in United States, France and 5 more
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)