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Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131742
First Posted: August 19, 2005
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis
August 18, 2005
August 19, 2005
May 12, 2015
July 2004
January 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00131742 on ClinicalTrials.gov Archive Site
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Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: telbivudine
  • Drug: lamivudine
Not Provided
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.
 
Completed
Not Provided
January 2007
January 2007   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
16 Years to 70 Years   (Child, Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00131742
NV-02B-015
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Novartis
Novartis Pharmaceuticals
Not Provided
Novartis
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP