Clinical trials: Hepatitis B Vaccine
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, Chronic
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV…
- Trial name
- NCT02791269
- Testing
- Peginterferon alfa-2a
- Where
- 6 sites in New Zealand
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B-related Liver Fibrosis
A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
This trial employs a single-arm, open-label, multicenter clinical trial design. All study participants who meet the inclusion/exclusion criteria will receive Hydronidone treatment for 4 weeks.
- Trial name
- NCT07417553
- Testing
- Hydronidone capsules
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Liver Fibrosis
Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated…
- Trial name
- NCT05905172
- Testing
- Hydronidone capsules
- Where
- 23 sites in China
- Volunteers
- 248 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Chronic Hepatitis B
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.
- Trial name
- NCT00037622
- Testing
- ACH-126, 443 (beta-L-Fd4C)
- Volunteers
- 100 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis B
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in…
- Trial name
- NCT00697931
- Testing
- Recombinant MPL- adjuvanted hepatitis B vaccine, Engerix™-B
- Where
- Belgium
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Study SCTA02A-A101 is designed to assess the safety, tolerability and pharmacokinetics of SCTA02A in healthy volunteers and participants with chronic hepatitis B virus infection.
- Trial name
- NCT07903831
- Testing
- SCTA02A
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sinocelltech Ltd.
Chronic Hepatitis B
A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B
The purpose of this study is to evaluate the safety and tolerability of JNJ-440 in healthy and Chronic Hepatitis B (CHB) participants after single and multiple doses; and to evaluate the pharmacokinetic (PK) of JNJ-440 in healthy…
- Trial name
- NCT03439488
- Testing
- JNJ-440
- Where
- 7 sites in Moldova, New Zealand and 3 more
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Hepatitis B, Chronic
A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.
- Trial name
- OSPREY (NCT05123599)
- Testing
- JNJ-73763989, JNJ-64300535, ETV monohydrate
- Where
- 13 sites in Belgium, France and 6 more
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B
Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets
To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic…
- Trial name
- NCT04868981
- Testing
- GST-HG141 tablets
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fujian Cosunter Pharmaceutical Co. Ltd
Hepatitis B Virus
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
- Trial name
- NCT03083821
- Testing
- Baraclude
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Bristol-Myers Squibb
Diphtheria, Tetanus
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00514709
- Testing
- DTaP-HB PRP~T Combined Vaccine, DTaP-HB-PRP~T vaccine, Oral Polio Vaccine
- Where
- 7 sites in Philippines
- Volunteers
- 1,843 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Chronic
A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B
This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine.
- Trial name
- NCT01705704
- Where
- 27 sites in Australia, France and 8 more
- Volunteers
- 269 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine.
- Trial name
- NCT00414050
- Testing
- Modified Process Hepatitis B Vaccine (Experimental), Hepatitis B Vaccine (Recombinant)
- Volunteers
- 1,718 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Chronic
Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already…
- Trial name
- NCT02726789
- Testing
- REP 2139-Ca, pegylated interferon, entecavir
- Volunteers
- 5 people
- Sponsor
- Replicor Inc.
Liver Fibrosis
ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard).
- Trial name
- NCT02313649
- Where
- 15 sites in China
- Volunteers
- 447 people
- Sponsor
- SuperSonic Imagine
Chronic Hepatitis B
Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet
- Trial name
- NCT02805738
- Testing
- CKD-390, viread
- Where
- 20 sites in South Korea
- Volunteers
- 158 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Chronic Hepatitis b
Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects
This is a single center, open-label, 3-Cohort, parallel, single-dose, study to evaluate the PK, safety, and tolerability of ATI-2173 50 mg administered orally in Japanese, Chinese, and Non-Asian healthy subjects incorporating a…
- Trial name
- NCT05298332
- Testing
- ATI-2173 50 mg
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Antios Therapeutics, Inc
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.
Chronic Hepatitis B
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently…
- Trial name
- NCT00307489
- Testing
- tenofovir DF, emtricitabine /tenofovir DF
- Where
- 28 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences