An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

Completed · Phase 2

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID

NCT00124241

Run by

Novartis

Expected to finish

2005-11-01

Last updated by the study team

2015-05-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient is pregnant or breast-feeding
• Patient has signs of decompensated chronic hepatitis B
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Toronto, Canada
• Study site — Hong Kong, China
• Study site — Paris, France

Full record on ClinicalTrials.gov

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