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

Novartis

Status and phase: Completed; Phase 4

Conditions: Compensated Chronic Hepatitis B

Treatments: Drug: telbivudine/LDT600

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877149

CLDT600ACN04E1

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

A

Experimental group

Treatment:

Drug: telbivudine/LDT600