Clinical trials: Hepatitis B Infections
Hepatitis B
A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of Sci-B-Vac vaccine produced…
- Trial name
- NCT04531098
- Testing
- Sci-B-Vac-Lot B, Sci-B-Vac-Lot A, Engerix-B
- Where
- Vietnam
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Chronic Hepatitis B
The Tolerability and Pharmacokinetics Clinical Trial of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug concentration in the plasma and urine after a…
- Trial name
- NCT03180333
- Testing
- PNA
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
Hepatitis B, Chronic
A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir
This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect when administered to non-treated…
- Trial name
- NCT04365933
- Testing
- EYP001a, Entecavir, Pegylated interferon alpha2a
- Where
- 6 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 20 people
- Sponsor
- Enyo Pharma
Hepatitis B
A Study of the Immune Response to Heplisav in Healthy Older Adults
This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.
- Trial name
- NCT01999699
- Testing
- HEPLISAV
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Chronic Hepatitis B
Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients
This Phase 1 trial will assess the dose-related safety and PK profile of different doses of NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with chronic hepatitis B (part II).
- Trial name
- NCT02112799
- Testing
- NVR 3-778, Pegasys
- Where
- 2 sites in New Zealand
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Novira Therapeutics, Inc.
Chronic Hepatitis B
Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B
This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and varying degrees of…
- Trial name
- NCT00071201
- Testing
- Adefovir Dipivoxil for oral suspension, 2 mg/mL
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B Infection
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum
This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have…
- Trial name
- NCT05355467
- Testing
- Tenofovir disoproxil fumarate, Historical Data
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Mylan (Taiwan) Ltd
Hepatitis B, Chronic
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus…
- Trial name
- NCT00962871
- Testing
- peginterferon alfa-2a [Pegasys], tenofovir
- Where
- 6 sites in United States, New Zealand and 2 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Diphtheria, Tetanus
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00654901
- Testing
- DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2), DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
- Where
- 4 sites in Mexico
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B
A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B
Hepatitis B virus (HBV) infection, especially chronic, is a significant worldwide medical problem. This is an exploratory study of the therapeutic mechanism of GSK3228836 in participants with chronic hepatitis B (CHB) on stable…
- Trial name
- B-Fine (NCT04544956)
- Testing
- GSK3228836, Nucleos(t)ide therapy
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic Hepatitis B Atypical
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
- Trial name
- NCT02981602
- Testing
- IONIS-HBVRx
- Where
- 7 sites in Hong Kong, South Korea
- Volunteers
- 31 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)
The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.
- Trial name
- NCT01376154
- Testing
- Lamivudine
- Volunteers
- 342 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12
- Trial name
- NCT00697970
- Testing
- HBsAg formulated with different concentrations of MPL and Aluminium Salts, Engerix™-B
- Where
- Austria
- Volunteers
- 321 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B
The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect…
- Trial name
- NCT02965859
- Testing
- Metacavir Enteric-coated Capsules 80mg, Metacavir Enteric-coated Capsules 160mg, Metacavir Enteric-coated Capsules 320mg
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
HIV Coinfection
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
- Trial name
- NCT01327547
- Testing
- Maraviroc
- Where
- 48 sites in United States, Czechia and 7 more
- Volunteers
- 138 people
- Sponsor
- ViiV Healthcare
Hepatitis B, Chronic
A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137…
- Trial name
- NCT06115993
- Testing
- AHB-137 injection
- Where
- 3 sites in China
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Ausper Biopharma Co., Ltd.
Hepatitis B
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.
- Trial name
- NCT00329576
- Testing
- Hepatitis B vaccine
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
- Trial name
- NCT00697125
- Testing
- Engerix™-B, HBV-MPL vaccine (208129), Hepatitis B vaccine, experimental formulation
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B Infection
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
- Trial name
- NCT02304315
- Testing
- GC1102 50,000 IU, GC1102 80,000 IU
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Green Cross Corporation
Tetanus, Poliomyelitis
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4…
- Conditions
- Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
- Trial name
- NCT01248884
- Testing
- Infanrix hexa™, Prevenar 13®, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline