Clinical trials: Hepatitis B Virus
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
Diphtheria, Acellular Pertussis
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B…
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b
- Trial name
- NCT00316147
- Testing
- DTPa-HBV-IPV/Hib vaccine
- Where
- 4 sites in India
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects
The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its…
- Trial name
- NCT04309526
- Testing
- NCO-48 Fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nucorion Pharmaceuticals, Inc.
Hepatitis B
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®.
- Trial name
- NCT04490499
- Testing
- HBVAXPRO™
- Where
- 10 sites in Finland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg…
- Trial name
- NCT01427868
- Testing
- LB80380 maleate salt, LB80380 free base
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Chronic Hepatitis B
Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
- Trial name
- NCT07246889
- Testing
- AHB-137, NA therapy
- Where
- 28 sites in China
- Volunteers
- 577 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects.
- Trial name
- NCT05310487
- Testing
- 162
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Yangshengtang Co., Ltd
Hepatitis B, Chronic
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
- Trial name
- OCTOPUS-1 (NCT05275023)
- Testing
- JNJ-73763989, PD-1 inhibitor, Tenofovir Disoproxil
- Where
- 26 sites in Canada, Czechia and 6 more
- Volunteers
- 37 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Hepatitis B
An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
- Trial name
- NCT01264354
- Testing
- Clevudine 30mg, Clevudine 20mg+Adefovir dipivoxil 10mg, Clevudine 20mg
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Bukwang Pharmaceutical
Poliomyelitis, Acellular Pertussis
Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.
- Conditions
- Poliomyelitis, Acellular Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00611559
- Testing
- Infanrix™ penta, Infanrix™ hexa
- Where
- 3 sites in Russia
- Volunteers
- 283 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
This trial is an experimental, randomized, double blind, prospective intervention study Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow: For adult (18-40 years old)
- Trial name
- NCT04188223
- Testing
- Recombinant Hepatitis B (Bio Farma) Vaccine, Recombinant Hepatitis B (Bio Farma) Vaccine®
- Where
- Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Diphtheria, Tetanus
A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults
This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT05952596
- Testing
- DTaP-HepB-IPV-Hib vaccine
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hepatitis B
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration…
- Trial name
- NCT00376259
- Testing
- telbivudine, adefovir dipivoxil
- Where
- 6 sites in United States, Hong Kong and 3 more
- Volunteers
- 43 people
- Sponsor
- Novartis
Diphtheria, Tetanus
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00404651
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-HBV-IPV vaccine
- Where
- 6 sites in Mexico
- Volunteers
- 1,189 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
HIV Infections, Hepatitis B Infections
Rapid Diagnostics for HIV and Hepatitis
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood.
- Conditions
- HIV Infections, Hepatitis B Infections, Hepatitis C Infections
- Trial name
- NCT02190305
- Testing
- Multiplo HBc/HIV/HCV and Reveal HBsAg
- Where
- 4 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Hepatitis B
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine…
- Trial name
- NCT00440531
- Testing
- Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental), Comparator: ENGERIX-B™ (currently licensed product)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and…
- Trial name
- NCT02115321
- Testing
- Grazoprevir, Elbasvir, MK-5172A
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Hepatitis, Viral
A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV
This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus
- Trial name
- ACHIEVE (NCT02751996)
- Testing
- SB 9200, Tenofovir
- Where
- 17 sites in Canada, Hong Kong and 2 more
- Volunteers
- 80 people
- Sponsor
- F-star Therapeutics, Inc.