Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in selected patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Telbivudine

Criteria

Inclusion Criteria:

• Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug.

• Patient was not discontinued from the previous CLDT600ACN04 study.

• Adult patients with CHB (HBeAg positive or HBeAg negative).

• HBV DNA PCR undetectable in recent 12 months.

Exclusion Criteria:

• Pregnant or breastfeeding, or has plan of pregnant during study period.

• Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit.

• Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.

Other protocol-defined inclusion/exclusion criteria may apply.