Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
Information source: Idenix Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: Lamivudine (Drug); Telbivudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Idenix Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Westmead, Australia
Beijing, China
Nice, France
Tel Aviv, Israel
Auckland, New Zealand
Singapore, Singapore
Tainan, Taiwan
Chiang Mai, Thailand
London, United Kingdom
San Diego, California, United States
New York, New York, United States
Toronto, Ontario, Canada
Philadelphia, Pennsylvania, United States
Montreal, Quebec, Canada
Additional Information
Last updated: November 14, 2007
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