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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2

Details

• Lead Sponsor: Novartis
• Collaborator: Novartis Pharmaceuticals
• Treatments: Lamivudine; Telbivudine

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.