Back to resultsAn Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
telbivudine
lamivudine
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria: Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug Patient remains seropositive for hepatitis B surface antigen (HBsAg) Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breast-feeding Patient has signs of decompensated chronic hepatitis B Other protocol-defined exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00124241
First Posted
July 25, 2005
Last Updated
May 8, 2015
Sponsor
Novartis
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00124241
Brief Title
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
Official Title
A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
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
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
Patient remains seropositive for hepatitis B surface antigen (HBsAg)
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patient is pregnant or breast-feeding
Patient has signs of decompensated chronic hepatitis B
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Toronto
Country
Canada
City
Hong Kong
Country
China
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
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