Clinical trials: Hepatitis B Vaccine
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
Chronic Hepatitis B
Phase 3 and Extensional Study of Besifovir
To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or…
- Trial name
- NCT01937806
- Testing
- besifovir 150mg, tenofovir 300mg
- Where
- 20 sites in South Korea
- Volunteers
- 197 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
Hepatitis B Vaccine
Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B
The purpose of this study is to assess the long-term protection against HBV infection in adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30 years ago
- Trial name
- NCT02901951
- Testing
- Engerix-B
- Where
- 4 sites in Belgium, Canada
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bacterial Infections, Virus Diseases
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
- Trial name
- NCT01340937
- Testing
- V419, PENTACEL™, Prevnar 13™
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
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, Chronic
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV).
- Trial name
- NCT00436163
- Testing
- Peginterferon alfa-2a
- Where
- 9 sites in Estonia, Latvia and 1 more
- Volunteers
- 39 people
- Sponsor
- Hoffmann-La Roche
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
Hepatitis B, Chronic
Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy.
- Trial name
- HBVQuant (NCT02167113)
- Where
- 90 sites in United States, Australia and 8 more
- Volunteers
- 331 people
- Sponsor
- Hologic, Inc.
Hepatitis B, Chronic Disease
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
- Trial name
- NCT00096785
- Testing
- entecavir, adefovir
- Where
- 24 sites in United States, Canada and 6 more
- Volunteers
- 69 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients
REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection.
- Trial name
- NCT02646189
- Testing
- REP 2139-Ca, Zadaxin, Pegasys
- Where
- Bangladesh
- Volunteers
- 12 people
- Sponsor
- Replicor Inc.
Diptheria Immunization, Tetanus Immunization
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing…
- Conditions
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization, Hepatitis B Immunization
- Trial name
- NCT06413121
- Testing
- Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV, Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV
- Where
- 11 sites in Bangladesh, India
- Volunteers
- 1,557 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Chronic Hepatitis B
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the…
- Trial name
- NCT00115245
- Testing
- Telbivudine (LdT), Adefovir Dipivoxil
- Where
- 15 sites in United States, Australia and 7 more
- Sponsor
- Novartis
Chronic Hepatitis B
Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
This Phase 1b trial will assess the dose-related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B.
- Trial name
- NCT02401737
- Testing
- NVR 3-778, Pegasys
- Where
- 10 sites in United States, China and 3 more
- Volunteers
- 58 people
- Sponsor
- Novira Therapeutics, Inc.
Hepatitis B Virus
A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants
This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.
- Trial name
- NCT03570658
- Testing
- RO7049389
- Where
- China
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic…
- Trial name
- NCT00507507
- Testing
- Tenofovir DF, FTC
- Where
- 45 sites in United States, Australia and 9 more
- Volunteers
- 126 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients
This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.
- Trial name
- HBV (NCT03485534)
- Testing
- Tenofovir Disoproxil Fumarate, Tenofovir Disoproxil
- Where
- South Korea
- Volunteers
- 189 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Hepatitis B
Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy…
- Trial name
- NCT05330455
- Testing
- GSK3965193, Bepirovirsen
- Where
- 14 sites in Canada, France and 4 more
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against…
- Trial name
- NCT02697474
- Testing
- Euvax B®: Hepatitis B vaccine
- Where
- 2 sites in Thailand
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company