A study in people with long-lasting hepatitis B to assess the effectiveness and safety of a combination of the two drugs Viread and Pegasys compared with each drug given on its own.
- Conditions
- Chronic Hepatitis BMedDRA version: 14.0Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-024586-45-GR
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
Anti-HBV treatment naïve subjects (Subjects who have taken less than 12 weeks of oral anti-HBV nucleoside therapy with the last dose greater than or equal to 24 weeks prior to screening are also eligible).
HBV DNA > 10^5 copies/mL for HBeAg- and > 10^6 copies/mL for HBeAg+ subjects
ALT > 2x ULN < 10x ULN
Creatinine clearance rate greater than or equal to 70 mL/min
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 706
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
Known cirrhosis and/or decompensated liver disease
Evidence of hepatocellular carcinoma
Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta,
osteochrondroses, multiple bone fractures)
Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
History of depression or psychiatric disease
Thyroid dysfunction
Co-infection with HIV, HCV or HDV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Efficacy of TDF (48 weeks) plus PEG (16 weeks) combination therapy versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined by loss of HBsAg<br><br>Serological responses (HBeAg loss and seroconversion, and HBsAg seroconversion)<br><br>Biochemical responses (ALT<ULN);Primary end point(s): The proportion of subjects with HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone.;Timepoint(s) of evaluation of this end point: Week 72;Main Objective: The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon a-2a (PEG) combination therapy for 48 weeks versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined by loss of HBsAg.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The proportion of subjects with HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone<br><br>The proportion of subjects who experience HBsAg loss at Week 96 and Week 120<br><br>The rate of quantitative HBsAg decline during the study<br><br>The proportion of subjects with virological response (HBV DNA level < 400 copies/mL) at Weeks 72, 96 and 120<br><br>The proportion of subjects with serological response (HBeAg loss and seroconversion, and HBsAg seroconversion) at Weeks 72, 96 and 120<br><br>The proportion of subjects who experience biochemical response (ALT<ULN) at Weeks 72, 96 and 120<br><br>The proportion of subjects who require re-initiation or change of therapy while on therapy or post-treatment;Timepoint(s) of evaluation of this end point: Weeks 72, 96 and/or 120<br>