Clinical trials: HBV
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
End Stage Renal Disease on Hemodialysis (Diagnosis)
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
- Trial name
- NCT03934736
- Testing
- HEPLISAV-B®
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Dynavax Technologies Corporation
Hepatitis B
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB.
- Trial name
- TDF in CHB (NCT01300234)
- Testing
- Tenofovir disoproxil fumarate (TDF) tablets, Adefovir dipivoxil (ADV) tablets
- Where
- 20 sites in China
- Volunteers
- 512 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment
The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.
- Trial name
- NCT01063036
- Testing
- Entecavir, Tenofovir
- Where
- 28 sites in France, Germany and 5 more
- Volunteers
- 144 people
- Sponsor
- Bristol-Myers Squibb
Haemophilus Influenzae Type b, Tetanus
Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a…
- Conditions
- Haemophilus Influenzae Type b, Tetanus, Hepatitis B, Whole Cell Pertussis
- Trial name
- NCT01106092
- Testing
- GSK2036874A vaccine, Zilbrix™/Hib vaccine, Poliorix™
- Where
- Philippines
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis D Infection
Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection
Randomized open-label substudy of daily Myrcludex B (MXB) plus pegylated interferon-alpha-2a (PEG-INF-a) in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B virus (HBV) co-infected with hepatitis delta…
- Trial name
- NCT02637999
- Testing
- PEG IFN alfa-2a, Myrcludex B
- Volunteers
- 24 people
- Sponsor
- Hepatera Ltd.
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
Immunologic Tests
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
- Trial name
- NCT01098006
- Testing
- Blood withdrawal
- Where
- 2 sites in Belgium
- Volunteers
- 99 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
- Trial name
- NCT00142298
- Testing
- Telbivudine (LdT)
- Where
- 39 sites in United States, Australia and 19 more
- Volunteers
- 1,869 people
- Sponsor
- Novartis Pharmaceuticals
Infections, Streptococcal
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK…
- Trial name
- NCT00547248
- Testing
- Synflorix, Tritanrix-HepB, Hiberix
- Where
- 7 sites in Philippines, Poland
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis A, Hepatitis B
Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult
This study will evaluate the persistence of the immune response to HAV (hepatitis A virus) antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with Twinrix Adult in the primary study, HAB-032…
- Trial name
- NCT01037114
- Testing
- Blood sampling, Engerix-B, Havrix
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis A
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis…
- Trial name
- NCT00289731
- Testing
- TWINRIX™, Engerix™-B, HAVRIX™
- Where
- 9 sites in Belgium, Czechia and 1 more
- Volunteers
- 596 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cirrhosis, Hepatitis B
FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy
This study will examine the effectiveness of the FibroScan device in differentiating fibrosis in patients with hepatitis B and C.
- Conditions
- Cirrhosis, Hepatitis B, Hepatitis C
- Trial name
- NCT00125762
- Testing
- FibroScan
- Where
- 3 sites in United States
- Volunteers
- 907 people
- Sponsor
- Afdhal, Nezam, M.D.
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
Hepatitis B, Chronic
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV).
- Trial name
- NCT01095835
- Testing
- Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg, Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg, Lamivudine (LAM)
- Where
- 22 sites in Italy
- Volunteers
- 131 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV…
- Trial name
- NCT02791269
- Testing
- Peginterferon alfa-2a
- Where
- 6 sites in New Zealand
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old.
- Trial name
- NCT00511095
- Testing
- HEPLISAV
- Where
- 7 sites in United States
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
HIV Infections
Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more…
- Trial name
- NCT00447902
- Testing
- tipranavir, ritonavir
- Where
- 30 sites in United States, Argentina and 5 more
- Volunteers
- 11 people
- Sponsor
- Boehringer Ingelheim
Hepatitis B
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
- Trial name
- INSIGHT (NCT04585789)
- Testing
- JNJ-73763989, JNJ-56136379, Entecavir (ETV)
- Where
- 10 sites in United States, Belgium and 7 more
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC