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

Novartis Pharmaceuticals80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Compensated Chronic Hepatitis B

Interventions

telbivudine/LDT600DRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (4)

Beijing Ditan Hospital

Beijing, China

First Hospital of Peking University

Beijing, China

Peking University People's Hospital

Beijing, China

Ruijin Hospital, Affiliated to 2nd Medical university

Shanghai, China

Outcomes

Primary Outcomes

To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.

Time frame: Visit 2 (week 1)

Secondary Outcomes

To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment

Time frame: weeks 1, 24, 52 and 24 weeks post-treatment

To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies

Time frame: weeks 24 and 52, 24 weeks post-treatment

To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion

Time frame: weeks 24, 52 and 24 weeks post-treatment

To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015

Time frame: Visit 2 (week 1)

Data from ClinicalTrials.gov

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