An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients 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: Hepatitis B
Intervention: telbivudine (Drug); lamivudine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Idenix Pharmaceuticals
Summary
This is an extension study for patients who have previously completed Idenix Study
NV-02B-003. This study is being conducted to compare the safety and effectiveness of
treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug
currently approved for the treatment of hepatitis B.
Clinical Details
Official title: A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has completed protocol NV-02B-003 without a serious adverse event attributed
to study drug
- Patient remains seropositive for hepatitis B surface antigen (HBsAg)
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breast-feeding
- Patient has signs of decompensated chronic hepatitis B
Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Toronto, Canada
Hong Kong, China
Paris, France
Los Angeles, California, United States
Additional Information
Last updated: March 1, 2007
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