Status:
COMPLETED
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00132652
Start Date
February 1 2005
End Date
December 1 2006
Last Update
February 23 2017
Active Locations (14)
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1
San Diego, California, United States
2
New York, New York, United States
3
Philadelphia, Pennsylvania, United States
4
Westmead, Australia