Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	August 18, 2005
Last Updated Date	March 1, 2007
Start Date ^†
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00131742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
Official Title ^†	A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
Brief Summary	This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Chronic Hepatitis B
Intervention ^†	Drug: telbivudine Drug: lamivudine
Study Arms / Comparison Groups
Publications *	Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, Wang Y, Zhu L, He Y, Ren H, Wan M, Chen C, Wu S, Chen Y, Xu J, Wang Q, Wei L, Chao G, Constance BF, Harb G, Brown NA, Jia J. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology. 2008 Feb;47(2):447-54.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Documented clinical history compatible with chronic hepatitis B infection Other protocol-defined inclusion criteria may apply Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog Other protocol-defined exclusion criteria may apply
Gender	Both
Ages	16 Years to 70 Years
Accepts Healthy Volunteers
Contacts ^††
Location Countries ^†	China
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00131742
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Idenix Pharmaceuticals
Collaborators ^††	Novartis
Investigators ^†
Information Provided By	Idenix Pharmaceuticals
Verification Date	March 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.