Status:
COMPLETED
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
Detailed Description
Patients from 6 feeder trials could be eligible to enter current study CLDT600A2303 ( NCT00142298) if they met inclusion/exclusion criteria. The feeder studies were as follows: * CLDT600A2302 (NV-02B...
Eligibility Criteria
Inclusion
- Patient completed a previous qualifying Idenix-Sponsored trial with telbivudine
- Patient was not discontinued from previous Idenix-Sponsored study
- Other protocol-defined inclusion criteria may apply
Exclusion
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis C, hepatitis D or HIV
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
1869 Patients enrolled
Trial Details
Trial ID
NCT00142298
Start Date
March 1 2005
End Date
November 1 2009
Last Update
August 21 2020
Active Locations (39)
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1
Novartis Investigational Site
Phoenix, Arizona, United States, 85001
2
Novartis Investigational Site
Los Angeles, California, United States, 90001
3
Novartis Investigational Site
Los Angeles, California, United States, 90073
4
Novartis Investigational Site
Pasadena, California, United States, 91103