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

Novartis

Status and phase: Completed; Phase 2

Conditions: Hepatitis B

Treatments: Drug: lamivudine; Drug: telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00124241

NV-02B-010

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind