Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

Novartis

Status and phase

Completed

Phase 3

Conditions

Chronic Hepatitis B

Treatments

Drug: Telbivudine

Drug: Lamivudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00132652

NV-02B-019

Details and patient eligibility

About

This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented clinical history compatible with chronic hepatitis B
Patient has compensated liver disease
Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis C, hepatitis D or HIV
Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months

Other protocol-defined exclusion criteria may apply.