An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467545

CLDT600AKR02

Details and patient eligibility

About

This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has completed the previous CLDT600A2407 study and is able to immediately enter this extension study with no study drug discontinuation
• Patient is willing and able to comply with the study drug regimen and all other study requirements
• The patient is willing and able to provide written informed consent to participate in the extension study.

Exclusion criteria

• Patient is pregnant or breastfeeding.
• Patient is co-infected with HCV, HDV, or HIV.
• History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)