Clinical trials: Hepatitis B Infections
Hepatitis B, Chronic
Efficacy and Safety of TAF in Patients With Suboptimal Response to Other Nucleos(t)Ides
Both tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are potent antiviral agents for hepatitis B virus (HBV) and recommended by the American Association for the Study of Liver Disease (AASLD) as well as the…
- Trial name
- NCT04201808
- Testing
- Tenofovir Alafenamide 25 MG
- Where
- 10 sites in China
- Volunteers
- 100 people
- Sponsor
- New Discovery LLC
Whole Cell Pertussis, Haemophilus Influenzae Type b
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of…
- Conditions
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Diphtheria
- Trial name
- NCT00136604
- Testing
- Tritanrix-HepB/Hib-MenAC, Mencevax ACWY, Tritanrix-HepB/Hiberix
- Where
- 3 sites in Thailand
- Volunteers
- 617 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Diphtheria
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib…
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b
- Trial name
- NCT00627458
- Testing
- Infanrix Hexa
- Where
- 6 sites in Finland
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50%…
- Trial name
- NCT06707922
- Testing
- Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
- Where
- 30 sites in China
- Volunteers
- 350 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
HIV-1/HBV Co-Infection
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate…
- Trial name
- Alliance (NCT03547908)
- Testing
- B/F/TAF, DTG, F/TDF
- Where
- 69 sites in United States, China and 12 more
- Volunteers
- 244 people
- Sponsor
- Gilead Sciences
Hepatitis B, Besifovir Dipivoxil Maleate
Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate
A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B
- Conditions
- Hepatitis B, Besifovir Dipivoxil Maleate, Tenofovir Disoproxil Fumarate
- Trial name
- NCT04202536
- Testing
- Besifovir Dipivoxil Maleate, Tenofovir disoproxil fumarate(TDF)
- Where
- South Korea
- Volunteers
- 152 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
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
Chronic Hepatitis B
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
- Trial name
- NCT00316719
- Testing
- LAM group, ADV group
- Volunteers
- 105 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
- Trial name
- NCT02604212
- Testing
- ARC-520, entecavir, antihistamine
- Where
- 16 sites in China, Germany and 1 more
- Volunteers
- 32 people
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Hepatitis b
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chronic Hepatitis B
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
- Trial name
- NCT05828745
- Testing
- CB06-036
- Where
- 2 sites in China, New Zealand
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Hepatitis B, Chronic
Drug Drug Interaction Study for EYP001 With Entecavir
This is a Phase 1, single-center, open-label, three subsequent dosing periods study to evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD), safety, and tolerability of a single dose of…
- Trial name
- NCT03469583
- Testing
- EYP001, Entecavir 1 MG
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Enyo Pharma
Chronic Hepatitis B
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
- Trial name
- NCT00857675
- Testing
- AAAA, AAPA, PAAA
- Where
- 10 sites in China
- Volunteers
- 480 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B Infections
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment…
- Trial name
- NCT07342868
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Aligos Therapeutics
Hepatitis B Infection, Chronic Infection
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high…
- Conditions
- Hepatitis B Infection, Chronic Infection, Viremia
- Trial name
- NCT01488526
- Testing
- TDF treatment
- Where
- 5 sites in China
- Volunteers
- 200 people
- Sponsor
- New Discovery LLC
Hepatitis B
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.
- Trial name
- NCT00362674
- Where
- 27 sites in South Korea
- Sponsor
- Bukwang Pharmaceutical
Diphtheria, Tetanus
Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth
The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT02428491
- Testing
- Hexaxim®
- Where
- Vietnam
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)
This is a multicenter, randomized, double-blind, parallel group, 48-week follow-up, Phase IIa clinical study. This study has been designed to evaluate the change in HBsAg (log10 IU/mL) after administration of hzVSF-v13 50 mg/dose…
- Trial name
- NCT05808335
- Testing
- Standard of care
- Where
- 4 sites in South Korea
- Volunteers
- 32 people
- Sponsor
- ImmuneMed, Inc.
Hepatitis B
Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B
This study evaluates the addition of birinapant in subjects with chronic Hepatitis B who are currently receiving anti-viral therapy with either tenofovir or entecavir.
- Trial name
- NCT02288208
- Testing
- Antiviral Therapy (tenofovir or entecavir), Birinapant
- Where
- 3 sites in Australia
- Volunteers
- 7 people
- Sponsor
- TetraLogic Pharmaceuticals
Hepatitis E, Hepatitis B
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine.
- Trial name
- NCT02584543
- Testing
- HEV vaccine, HBV vaccine
- Where
- China
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis C
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and…
- Trial name
- D-LITE (NCT01309932)
- Testing
- Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor), Ribavirin (RBV)
- Where
- 40 sites in United States, Australia and 7 more
- Volunteers
- 165 people
- Sponsor
- Bristol-Myers Squibb