Clinical Trial: Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single Arm, Multicenter, Open-label, 52-week, the Omnibus Extension Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated
Brief Summary: This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Proportion of patients experiencing serious adverse events (for all SAEs, and SAEs attributed to study drug). Proportion of patients experiencing adverse events, coded by body system ( all AEs, and AEs attributed to study drug). [ Time Frame: At Baseline, Week 24 and Week 52 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: For HBeAg-positive patients, Maintained Virologic Response, here defined as HBeAg loss and serum HBV DNA PCR negative (COBAS Amplicor PCR < 300 copies/ml) during the whole study period. [ Time Frame: At Baseline, Week 24 and Week 52 ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: March 26, 2008
Date Started: March 2008
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016