Back to resultsTelbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
telbivudine
lamivudine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00131742
First Posted
August 18, 2005
Last Updated
May 8, 2015
Sponsor
Novartis
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00131742
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
telbivudine
Intervention Type
Drug
Intervention Name(s)
lamivudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
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
Facility Information:
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
18080339
Citation
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. doi: 10.1002/hep.22075.
Results Reference
derived
Learn more about this trial
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
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