Chronic Hepatitis B MedDRA version: 8.1 Level: LLT Classification code 10008910
Conditions
Sponsors
Gilead Sciences Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 treatment group • To determine the incidence and patterns of drug resistance mutations in HBV DNA polymerase in each treatment group;Primary end point(s): The co-primary endpoints to be evaluated among treatment groups in this exploratory study will include the following: • Proportion of subjects experiencing tolerability failure. Tolerability failure is defined as permanent discontinuation of study drug due to a treatment-emergent AE. Any patient that temporarily discontinues study drug due to an AE but does not restart study drug will be considered a tolerability failure. • Proportion of subjects with a confirmed increase in serum creatinine of = 0.5 mg/dL from baseline or a confirmed serum phosphorus < 2.0 mg/dL | — |
Countries
Germany, Greece, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed