Clinical trials: Viral Hepatitis B
Chronic Hepatitis B
APG-1387 Study of Safety, Tolerability ,PK/PD in Patients With Chronic Hepatitis B
This study is a Multiple Ascending Dose study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of APG-1387 in Chronic Hepatitis B Patients.
- Trial name
- NCT03585322
- Testing
- APG-1387 for Injection
- Where
- 2 sites in China
- Volunteers
- 49 people
- Sponsor
- Ascentage Pharma Group Inc.
Hepatitis B
This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy and to assess the anamnestic response…
- Trial name
- NCT02052661
- Testing
- Engerix™-B Kinder
- Where
- 11 sites in Germany
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B
The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic vaccine administered as an adjunct therapy to…
- Trial name
- NCT02249988
- Testing
- ABX203 therapeutic Hepatitis B vaccine treatment arm
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 261 people
- Sponsor
- Abivax S.A.
Hepatitis B
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from…
- Trial name
- NCT05561673
- Testing
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system, GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled.
- Trial name
- NCT03181113
- Testing
- Peginterferon Alfa-2B, Peginterferon Alfa-2A
- Where
- 28 sites in China
- Volunteers
- 473 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatitis B, Chronic
An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study
This open--label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with peginterferon alfa-2a in participants with chronic hepatitis B (CHB).
- Trial name
- NCT02201407
- Testing
- Peginterferon alfa-2a
- Where
- 6 sites in Serbia
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic, Chronic Hepatitis B
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814.
- Trial name
- NCT00403585
- Testing
- adefovir dipivoxil 10mg
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
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 Infection
A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process.
- Trial name
- NCT00489099
- Testing
- V232 Modified Process Hepatitis B Vaccine: Lot A, V232 Modified Process Hepatitis B Vaccine: Lot B, V232 Modified Process Hepatitis B Vaccine: Lot C
- Volunteers
- 860 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Chronic
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB)…
- Trial name
- NCT01023230
- Testing
- DV-601, Entecavir
- Where
- 4 sites in Poland
- Volunteers
- 14 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Hepatitis B
Safety and Tolerability of TG1050: A Dose-finding Study
Methodology: This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection.
- Trial name
- NCT02428400
- Testing
- TG1050
- Where
- 12 sites in Canada, France and 1 more
- Volunteers
- 48 people
- Sponsor
- Transgene
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
A Phase II Dose Response Study in Japan in Chronic Hepatitis B
To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22
- Trial name
- NCT01022801
- Testing
- Entecavir
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Polio
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00401531
- Testing
- DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines, DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
- Where
- 2 sites in Thailand
- Volunteers
- 412 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Diphtheria, Tetanus
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01177722
- Testing
- DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-Hep B-IPV vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,375 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
HBeAg-Positive Chronic Hepatitis B
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B.
- Trial name
- NCT01913431
- Testing
- Baracle Tab.®, Baraclude Tab.®
- Where
- South Korea
- Volunteers
- 118 people
- Sponsor
- Dong-A ST Co., Ltd.
Hepatitis B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic, Pregnancy Related
Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B
Immunoprophylaxis failure of hepatitis B (HBV) remains a concern and has been reported in approximately 10-30% of infants born to highly viremic mothers with HBeAg-positive.
- Trial name
- NCT04211805
- Testing
- Tenofovir Alafenamide 25 MG for arm (A), Tenofovir Disoproxil Fumarate 300mg for arm (B)
- Where
- 11 sites in China
- Volunteers
- 450 people
- Sponsor
- New Discovery LLC
Recurrent Hepatocellular Carcinoma
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries.
- Trial name
- NCT03634683
- Testing
- LioCyx
- Where
- 3 sites in China, Singapore
- Sponsor
- Lion TCR Pte. Ltd.