Clinical trials: Hepatitis B Infections
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
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV
The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.
- Trial name
- NCT00313287
- Testing
- clevudine
- Where
- 33 sites in South Korea
- Volunteers
- 180 people
- Sponsor
- Bukwang Pharmaceutical
Hepatitis B, Chronic
A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of…
- Trial name
- NCT06452693
- Testing
- Nucleotide drugs Control group
- Where
- 22 sites in China
- Volunteers
- 162 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatitis B, Chronic
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety…
- Trial name
- NCT02952924
- Testing
- Midazolam, RO7049389
- Where
- 21 sites in Australia, Bulgaria and 6 more
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge
The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.
- Trial name
- NCT00411697
- Testing
- Engerix™-B Kinder
- Where
- 36 sites in Germany
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Acceptability of Hepatitis B Vaccination in General Population
The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general population before and after reimbursement of the paediatric vaccine InfanrixHexa.
- Trial name
- PopCorn (NCT01782794)
- Testing
- Data collection
- Volunteers
- 2,413 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.
- Trial name
- NCT00696917
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Where
- 7 sites in Australia, Czechia and 5 more
- Volunteers
- 1,303 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
This multi-country, longitudinal follow-up study will enrol adults with chronic hepatitis B (CHB) who previously participated in the Phase III B-Well-1 ((202009: NCT05630807) or B-Well-2 (219288: NCT05630820) studies, received 24…
- Trial name
- B-Ensure (NCT07908459)
- Testing
- Bepirovirsen
- Volunteers
- 303 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection
This study uses random, double -blindness, placebo control, and phase multi -center test design. All subjects who meet the standards receive TQ-A3334 per tablet/placebo nucleoside (acid) analog. A total of 116 subjects are needed.
- Trial name
- NCT06706310
- Testing
- TQA3334 Tablet, Nucleoside (acid) analogs (NAs)
- Where
- 15 sites in China
- Volunteers
- 116 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatitis B, Chronic
Lamivudine(LAM) Good Responder Study
This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.
- Trial name
- LAMGR (NCT01128686)
- Testing
- No intervention
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- ViiV Healthcare
Chronic HBV Infection
Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection
The primary objective of this study is to compare the safety and efficacy of HS-10234 versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT03903796
- Testing
- HS-10234, TDF
- Where
- China
- Volunteers
- 963 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Haemophilus Influenzae Type b, Diphtheria
Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants
The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given…
- Conditions
- Haemophilus Influenzae Type b, Diphtheria, Whole Cell Pertussis, Hepatitis B
- Trial name
- NCT00290303
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- 3 sites in Philippines
- Volunteers
- 996 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous…
- Trial name
- NCT00699231
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, HBV
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules.
- Trial name
- NCT01590641
- Testing
- Single Ascending Dose (SAD) Cohorts GS-9620, Multiple Ascending Dose (MAD) Cohorts
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 49 people
- Sponsor
- Gilead Sciences
Tetanus, Poliomyelitis
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
- Conditions
- Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b
- Trial name
- NCT00871741
- Testing
- GSK2202083A vaccine, Infanrix hexa, Menjugate
- Where
- 8 sites in Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy
This Phase 1b clinical study is a multi-center, open-label, dose escalation, prime only, and prime plus boost therapeutic vaccination study of 2 distinct chimpanzee adenoviral vectors (AdC6 and AdC7), containing parts of…
- Trial name
- NCT06070051
- Testing
- VRON-0200-AdC6, VRON-0200-AdC7, VIR-2218
- Where
- 3 sites in Hong Kong, New Zealand
- Volunteers
- 35 people
- Sponsor
- Virion Therapeutics
Chronic Hepatitis B Virus Infection
A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
- Trial name
- NCT04971512
- Testing
- EDP-721, EDP-721 (Part 2), EDP-514
- Where
- New Zealand
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Chronic Hepatitis B Infection, Chronic Hepatitis D Infection
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
Primary objective: To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection Secondary objectives: 1.
- Trial name
- NCT04638439
- Testing
- P1101 + Nivolumab + Entecavir
- Where
- 5 sites in Taiwan
- Volunteers
- 20 people
- Sponsor
- PharmaEssentia
Hepatitis B, Chronic
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.
- Trial name
- NCT01475851
- Testing
- GSK548470 300 mg tablet
- Where
- 11 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Hepatitis B， Chronic
Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients
- Trial name
- NCT02967939
- Testing
- DA-2802, Viread®
- Where
- South Korea
- Volunteers
- 123 people
- Sponsor
- Dong-A ST Co., Ltd.