A Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon alfa-2a (Pegasys) versus Tenofovir Disoproxil Fumarate or Peginterferon alfa-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects.

Phase 1

• Conditions: on-cirrhotic subjects with HBeAg-positive or HBeAg-negative chronic hepatitis B; MedDRA version: 14.1Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024586-45-IT
• Lead Sponsor: GILEAD SCIENCE INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-13
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

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 > 60 U/L and = 400 U/L for men and > 40 U/L and = 300 U/L for women; - Creatinine clearance rate greater than or equal to 80 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 705
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Known bridging fibrosis or cirrhosis and/or decompensated liver disease. 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 severe depression or severe psychiatric disease. Thyroid dysfunction. Co-infection with HIV, HCV or HDV . Ongoing therapy with any of the following: - Nephrotoxic agents; - Hepatotoxic agents; - Competitors of renal excretion; - Systemic chemotherapeutic agents; - Systemic corticosteroids; - Interleukin-2 (IL-2) and other immunomodulating agents; - Investigational agents. Administration of any of the above mentioned medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified