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

Novartis

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Hepatitis B

Interventions

telbivudineDRUG

lamivudineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (4)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Toronto, Canada

Unnamed facility

Hong Kong, China

Unnamed facility

Paris, France

Data from ClinicalTrials.gov

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