Back to resultsSwitching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lamivudine
Telbivudine
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 Patient has compensated liver disease Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C, hepatitis D or HIV Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months Other protocol-defined exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00132652
First Posted
August 18, 2005
Last Updated
February 21, 2017
Sponsor
Novartis
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00132652
Brief Title
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
Official Title
A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (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 safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.
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
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Telbivudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented clinical history compatible with chronic hepatitis B
Patient has compensated liver disease
Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis C, hepatitis D or HIV
Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
San Diego
State/Province
California
Country
United States
City
New York
State/Province
New York
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Westmead
Country
Australia
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Beijing
Country
China
City
Nice
Country
France
City
Tel Aviv
Country
Israel
City
Auckland
Country
New Zealand
City
Singapore
Country
Singapore
City
Tainan
Country
Taiwan
City
Chiang Mai
Country
Thailand
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
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