A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

Phase 2

• Conditions: Chronic Hepatitis B; Inflammatory and Immune System - Liver

• Registration Number: ACTRN12607000371493
• Lead Sponsor: Gilead

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

To be eligible for participation, at screening subjects with chronic Hepatitis B Virus (HBV) infection [Hepatitis B Surface Antigen (HBsAg) > 6 months or HBsAg positive > 3 months and negative for Immunoglobulin M (IgM), Antibodies to Hepatitis B Core Antigen (anti-HBc) and positive for Immunoglobin G (IgG) anti-HBc], HBV DNA levels > or = 10^8 copies/mL, Alanine Transferase (ALT) levels > or = Upper Limit of Normal (ULN), creatinine clearance > or = 70 mL/min, alpha-fetoprotein < 50 ng/mL.

Exclusion Criteria

Subjects must be naïve to oral HBV therapy and without serological evidence of co-infection with Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), or Hepatitis D Virus (HDV). Previous treatment with interferon must have ended at least 6 months prior to the screening visit. Subjects with decompensated liver disease as well as pregnant or breast-feeding females will be excluded from the study. Regular visits will involve the review of vital signs and collection of blood to perform routine lab tests of serum chemistry, liver tests, hematology and HBV DNA. Tests specific to HBV and a physical examination will be done at specific visits. A sample of urine will also be collected at each visit for urinalysis and a urine pregnancy test will be requested for females of child bearing potential.

Study & Design

• Study Type: Interventional
• Study Design: Not specified