A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects with Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantatio
- Conditions
- Chronic Hepatitis BMedDRA version: 8.1Level: LLTClassification code 10008910
- Registration Number
- EUCTR2005-004096-37-ES
- Lead Sponsor
- Gilead Sciences Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
• Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
• 18 through 69 years of age (inclusive)
• Serum HBV DNA = 10000 copies/mL (PCR method)
• Decompensated liver disease with all of the following:
- CPT score of 7-12 (inclusive)
- Serum ALT < 10 × ULN
- Hemoglobin = 7.5 g/dL
- Total WBC count = 1,500/mm3
- Platelet count = 30,000/mm3
• a-fetoprotein = 20 ng/mL and ultrasound or other imaging with no evidence of HCC, or a-fetoprotein of 21-50 ng/mL and CT/MRI with no evidence of HCC, within 3 months of screening
• Calculated creatinine clearance (CLcr) = 50 mL/min using the Cockcroft-Gault equation
• Negative HIV, HCV, and HDV serologies
• Less than 24 months of total prior adefovir dipivoxil exposure
• Willing and able to provide written informed consent
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
• Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
• Males and females of reproductive potential who are unwilling to use an effective” method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used
• Prior use of tenofovir DF or entecavir
• History of variceal bleeding, hepatorenal syndrome, hepatic encephalopathy, or spontaneous bacterial peritonitis within 60 days of screening
• History of solid organ or bone marrow transplant
• Current use of hepatotoxic drugs, nephrotoxic drugs, or drugs that interfere with renal tubular secretion
• Current therapy with immunomodulators (e.g., corticosteroids, IL-2, etc.) or investigational agents
• Diagnosis of proximal tubulopathy
• Use of any investigational agent within 30 days prior to the screening visit
• Known hypersensitivity to tenofovir DF (or tenofovir), emtricitabine, entecavir, or formulation excipients of any of the study drug products
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method