Clinical trials: Hepatitis B Virus
Chronic Hepatitis B
Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients.
- Trial name
- NCT01379508
- Testing
- telbivudine, tenofovir disoproxil fumarate
- Where
- 34 sites in Austria, Bulgaria and 6 more
- Volunteers
- 241 people
- Sponsor
- Novartis Pharmaceuticals
Immunologic Tests
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
- Trial name
- NCT01098006
- Testing
- Blood withdrawal
- Where
- 2 sites in Belgium
- Volunteers
- 99 people
- Sponsor
- GlaxoSmithKline
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis b, Liver Inflammation
Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium…
- Trial name
- MAGIC-101 (NCT03349008)
- Testing
- Entecavir, Magnesium Isoglycyrrhizinate, Diammonium Glycyrrhizinate
- Volunteers
- 480 people
- Sponsor
- Cttq
Advanced Melanoma, Hepatitis B
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C…
- Conditions
- Advanced Melanoma, Hepatitis B, Hepatitis C
- Trial name
- Yervoy RMP (NCT02402699)
- Where
- Taiwan
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
Chronic HBV Infection (HBeAg Negative)
REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection
REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act…
- Trial name
- NCT02233075
- Testing
- REP 2139-Ca + Pegasys (TM)
- Where
- Moldova
- Volunteers
- 12 people
- Sponsor
- Replicor Inc.
Hepatitis B, Hepatitis A
Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.
- Trial name
- NCT00197171
- Testing
- Combined Hepatitis A and B vaccine
- Where
- 2 sites in Australia
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB
This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs…
- Trial name
- NCT07095855
- Testing
- ZM-H1505R 100mg, NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments
- Where
- China
- Volunteers
- 1,300 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Acellular Pertussis, Tetanus
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA…
- Conditions
- Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT02422264
- Testing
- Infanrix hexa, Prevnar13
- Where
- 30 sites in Australia, Canada and 4 more
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis b
Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B
This is a Phase4, multicenter, open-label, randomized study to demonstrate that the Tenolid Tab switching group is non-inferior to the virologic suppression effect compared to the Viread Tab continuous administration group and…
- Trial name
- NCT05286346
- Testing
- Tenofovir disoproxil 245mg, Tenofovir disoproxil fumarate 300mg
- Where
- South Korea
- Volunteers
- 113 people
- Sponsor
- Samjin Pharmaceutical Co., Ltd.
Hepatitis B
Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy
The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug…
- Trial name
- NAs resistance (NCT02791386)
- Where
- China
- Volunteers
- 383 people
- Sponsor
- Bristol-Myers Squibb
Diphtheria, Tetanus
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00343889
- Testing
- DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine, Oral Polio Vaccine
- Where
- 2 sites in Philippines
- Volunteers
- 379 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Chronic
A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects with Chronic Hepatitis B
- Trial name
- NCT04426968
- Testing
- Hepalatide 2.1mg, Hepalatide 4.2mg, Hepalatide 6.3mg
- Where
- 12 sites in China
- Volunteers
- 96 people
- Sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.
Hepatitis B, Chronic
Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253
This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a).
- Trial name
- NCT01237496
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 5 sites in Italy
- Volunteers
- 17 people
- Sponsor
- Hoffmann-La Roche
Diphtheria, Tetanus
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT05457946
- Testing
- LBVD (Hexavalent vaccine), Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hepatitis B, Chronic
Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China
This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.
- Trial name
- NCT04507269
- Testing
- VIR-2218
- Where
- 2 sites in China
- Volunteers
- 21 people
- Sponsor
- Brii Biosciences Limited
Hepatitis B, Chronic
A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with…
- Trial name
- NCT05484466
- Testing
- ZM-H1505R, Baraclude
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Chronic Hepatitis B
A Study Evaluating AHB-137 in Healthy Participants and Participants with Chronic Hepatitis B
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses.
- Trial name
- NCT05717686
- Testing
- AHB-137 injection
- Where
- 9 sites in United States, Hong Kong and 2 more
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AusperBio Therapeutics Inc.
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831753
- Testing
- DTaP IPV HB PRP~T vaccine, DTaP-HB-IPV and Haemophilus influenzae type b
- Where
- Peru
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Liver Fibrosis, HEPATITIS B CHRONIC
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients
The purpose of this study is to determine whether an investigational drug DCB-BO1202 is effective and safe in the treatment of liver fibrosis in HBV patients having experienced intermediate stage hepatocellular carcinoma (HCC)
- Conditions
- Liver Fibrosis, HEPATITIS B CHRONIC, Hepatocellular Carcinoma
- Trial name
- NCT02289300
- Testing
- DCB-BO1202
- Where
- Taiwan
- Sponsor
- A2 Healthcare Taiwan Corporation