Clinical trials: Hepatitis b Virus
Vaccination Adverse Event, Immunogenicity, Vaccine
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
- Trial name
- NCT07854847
- Testing
- In-house Hepatitis B Vaccine, Registered Hepatitis B Vaccine
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
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
Hepatitis B, Tetanus
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in…
- Conditions
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT00753649
- Testing
- Infanrix™ hexa
- Where
- 3 sites in Canada
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Diphtheria
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination…
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT00970307
- Testing
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), Infanrix hexa™
- Where
- 9 sites in Poland
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B-related Liver Fibrosis
[¹⁴C] Hydronidone Mass Balance Study
According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it…
- Trial name
- NCT07471217
- Testing
- [¹⁴C]Hydronidone
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Hepatitis B, Chronic
Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB
Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB).
- Trial name
- NCT06743438
- Testing
- Tenofovir Amibufenamide（TMF）
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hepatocellular Carcinoma
Cell-free DNA From Junction of Hepatitis B Virus Integration in HCC Patients for Monitoring Post-resection Recurrence
HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC.
- Trial name
- NCT05823584
- Where
- Taiwan
- Volunteers
- 207 people
- Sponsor
- TCM Biotech International Corp.
Hepatitis B
Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule
The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available…
- Trial name
- NCT00480116
- Testing
- Adjuvanted Hepatitis B vaccine Lot 1, Adjuvanted Hepatitis B vaccine Lot 2, Adjuvanted Hep B vaccine Lot 3
- Where
- Czechia
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Henogen
Diphtheria, Tetanus
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
The present trial is a follow-up of AL203 study (NCT00343889). Primary Objectives: To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00534833
- Testing
- DTaP-HB-PRP~T vaccine, Tritanrix-HepB/Hib™, Oral Polio Vaccine
- Where
- 2 sites in Philippines
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
- Trial name
- NCT00936715
- Testing
- FTC/TDF
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Hepatitis B
Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201
The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine
- Trial name
- NCT00362700
- Testing
- Clevudine
- Where
- 7 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- Bukwang Pharmaceutical
Diphtheria, Tetanus
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT06947499
- Testing
- LBVD, Pentavalent vaccine and Inactivated Polio vaccine
- Where
- Philippines
- Volunteers
- 1,186 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hepatitis B Vaccine
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy.
- Trial name
- NCT00519649
- Testing
- Engerix™-B Kinder
- Where
- 35 sites in Germany
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable…
- Trial name
- NCT00393484
- Testing
- Entecavir, Lamivudine
- Where
- 15 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
- Trial name
- NCT00142298
- Testing
- Telbivudine (LdT)
- Where
- 39 sites in United States, Australia and 19 more
- Volunteers
- 1,869 people
- Sponsor
- Novartis Pharmaceuticals
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
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing.
- Trial name
- NCT00277576
- Testing
- ppdpSC18 administered by PMED
- Where
- 9 sites in Hong Kong, Singapore and 2 more
- Volunteers
- 48 people
- Sponsor
- PowderMed
Hepatitis B, Poliomyelitis
Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events.
- Conditions
- Hepatitis B, Poliomyelitis, Diphtheria, Tetanus
- Trial name
- NCT00146835
- Testing
- Pediarix, Licensed DTPa containing vaccine, Prevnar®: (Wyeth)
- Volunteers
- 120,794 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b Infection
- Trial name
- NCT02094833
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
- Where
- 16 sites in South Korea
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company