A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB).
- Conditions
- Chronic Hepatitis BMedDRA version: 12.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
- Registration Number
- EUCTR2010-024586-45-FR
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 751
Anti-HBV treatment naïve adult 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 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 Objective: The secondary objectives of this study are to evaluate:<br><br>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.
- Secondary Outcome Measures
Name Time Method