Clinical Trial: A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-arm, Multinational, Two Year Study Evaluating the Efficacy and Safety of lead-in Telbivudine for 24 Weeks With or Without Tenofovir Treatment Intensification in Adult Patients With HBeAg-posi

Brief Summary: This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: The primary objective of the study is to determine if telbivudine early non-responders can achieve an antiviral response with the addition of tenofovir. [ Time Frame: at week 52 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To estimate the rate of virologic breakthrough up to week 48 and week 104 To assess the rate of treatment-emergent genotypically confirmed HBV resistance associated with viral breakthrough up to weeks 48 and 104 and 104 [ Time Frame: at week 52 and 104 ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: March 18, 2008
Date Started: February 2008
Date Completion:
Last Updated: March 6, 2014
Last Verified: March 2014