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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Compensated Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

telbivudine/LDT600

Intervention Type DRUG

Interventions

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telbivudine/LDT600

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No