Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B
1 other identifier
interventional
240
11 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2005
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 18, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 23, 2017
February 1, 2017
1.8 years
August 18, 2005
February 21, 2017
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Novartis Pharmaceuticalscollaborator
Study Sites (14)
Unknown Facility
San Diego, California, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Westmead, Australia
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Beijing, China
Unknown Facility
Nice, France
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Auckland, New Zealand
Unknown Facility
Singapore, Singapore
Unknown Facility
Tainan, Taiwan
Unknown Facility
Chiang Mai, Thailand
Unknown Facility
London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 18, 2005
First Posted
August 22, 2005
Study Start
February 1, 2005
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 23, 2017
Record last verified: 2017-02