Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

This study has been completed.

Sponsor:

Collaborator:

Novartis

Information provided by:

Idenix Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00131742

First received: August 18, 2005

Last updated: March 1, 2007

Last verified: March 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	August 18, 2005
Last Updated Date	March 1, 2007
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00131742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
Official Title ^ICMJE	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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	Drug: telbivudine Drug: lamivudine
Study Arm (s)	Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT00131742
Other Study ID Numbers ^ICMJE	NV-02B-015
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Idenix Pharmaceuticals
Collaborators ^ICMJE	Novartis
Investigators ^ICMJE	Not Provided
Information Provided By	Idenix Pharmaceuticals
Verification Date	March 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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