Clinical trials: HBV Infection
Pertussis, Tetanus
Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis
Primary objective: To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus…
- Conditions
- Pertussis, Tetanus, Diphtheria, Poliomyelitis
- Trial name
- NCT02040636
- Testing
- Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV, Hepatitis B vaccine
- Where
- Canada
- Volunteers
- 277 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B.
- Trial name
- NCT00435825
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 55 sites in United States, Australia and 11 more
- Volunteers
- 551 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Disease
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
- Trial name
- NCT00985426
- Testing
- HEPLISAV-B, Engerix-B
- Where
- United States
- Volunteers
- 521 people
- Sponsor
- Dynavax Technologies Corporation
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.
Diphtheria, Tetanus
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781).
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01983540
- Testing
- DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine, Infanrix hexa + Prevenar + Rotarix vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 558 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Hepatitis B
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
- Conditions
- Diphtheria, Hepatitis B, Whole Cell Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00317135
- Testing
- Tritanrix-HepB/Meningitec conjugate vaccine, Tritanrix/Hiberix vaccine
- Where
- Philippines
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis A
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis…
- Trial name
- NCT00289718
- Testing
- Twinrix™ adult
- Where
- Belgium
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.
- Trial name
- B-Focus (NCT06497504)
- Testing
- Bepirovirsen
- Where
- 51 sites in United States, Argentina and 8 more
- Volunteers
- 153 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Healthy
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication.
- Trial name
- NCT04297917
- Testing
- ChAdOx1-HBV
- Where
- 4 sites in United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Barinthus Biotherapeutics
Chronic Hepatitis B
A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B
This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.
- Trial name
- NCT04180150
- Testing
- TQ-A3334, Entecavir Tablet
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c.
- Trial name
- NCT00460850
- Testing
- peginterferon alfa-2a (40KD) [PEGASYS]
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Hoffmann-La Roche
Healthy
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
- Trial name
- NCT02117934
- Testing
- HEPLISAV, Engerix-B
- Where
- 40 sites in United States
- Volunteers
- 8,374 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Liver Fibrosis
ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard).
- Trial name
- NCT02313649
- Where
- 15 sites in China
- Volunteers
- 447 people
- Sponsor
- SuperSonic Imagine
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Chronic Hepatitis B
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.
- Trial name
- NCT00035633
- Testing
- Entecavir
- Where
- 35 sites in United States
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B Virus (HBV) Infection
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection…
- Trial name
- NCT06650852
- Testing
- BRII-179, BRII-835 (VIR-2218), PEG-IFNα
- Where
- 14 sites in China
- Volunteers
- 250 people
- Sponsor
- Brii Biosciences Limited
Infections, Streptococcal
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by…
- Trial name
- NCT01204658
- Testing
- Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2), Synflorix
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 576 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects
- Trial name
- NCT03662568
- Testing
- GLS4, RTV, ETV
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatitis B, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01519960
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 39 sites in United States, Australia and 10 more
- Volunteers
- 165 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine
This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.
- Trial name
- NCT00289796
- Testing
- DTPa-HBV-IPV/Hib
- Where
- Germany
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline