Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: lamivudine; Drug: telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131742

NV-02B-015

Details and patient eligibility

About

This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented clinical history compatible with chronic hepatitis B infection

Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Patient is pregnant or breastfeeding
• Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
• Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog

Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind