A phase 2, double-blind, multicenter, 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 B with decompensated liver disease
MedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2005-004096-37-IT

Lead Sponsor: Gilead Sciences Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

-Seruma HBV DNA >=100000 copie/mL -Child-Pugh-Turcotte (CPT) score of 7-12 8inclusive) -Serum ALT < 10X ULN -Calculated creatinine clearance (Cockcroft-Gault) >= 50 mL/min - Hemoglobin >= 7.5 g/dL - alpha-fetoprotein (AFP)<=20 ng/mL and ultrasound or other imaging with no evidence of HCC, or alpha-fetoprotein of 21-50 ng/mL and CT/MRI with no evidence of HCC, within 3 months of screening.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy or breast-feeding - Solid organ or bone marrow transplant - Prior use of tenofovir DF or entecavir

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate, emtricitabine plus tenofovir disoproxil fumarate, and entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease.;Secondary Objective: - To provide a preliminary assessment of the relative efficacy of tenofovir disoproxil fumarate, emtricitabine plus tenofovir disoproxil fumarate, and entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease; - To determine the probability of remaining free from HBV recurrence post-transplantation in each tratment group; - To determine the incidence and patterns of drug resistance mutations in HBV DNA polymerase in each treatment group.;Primary end point(s): -CPT ( Child-Pugh-Turcotte) scores - serum HBV DNA levels - ALT levels Model for End Stage Liver Disease (MELD) scores - HBeAg, HbeAb; HBsAg; HBsAb

Secondary Outcome Measures