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

August 18, 2005
March 1, 2007
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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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: telbivudine
  • Drug: lamivudine
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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
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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

Both
16 Years to 70 Years
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Contact information is only displayed when the study is recruiting subjects
China
 
NCT00131742
NV-02B-015
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Idenix Pharmaceuticals
Novartis
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Idenix Pharmaceuticals
March 2007

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