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

A Single-arm, Multicenter, Open-label, 52-week Treatment, Extension Study to CLDT600ACN04 Study to Evaluate the Efficacy (Including Histological Improvement) and Safety in Fourth to Sixth Year of Telbivudine Treatment in Patients With Chronic Hepatitis B

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00877149

Enrollment

Registered

2009-04-07

Start date

2009-03-31

Completion date

Unknown

Last updated

2012-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compensated Chronic Hepatitis B

Keywords

Chronic HBV

Brief 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

Interventions

DRUGtelbivudine/LDT600

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.	Visit 2 (week 1)

Secondary

Measure	Time frame
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	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	weeks 24 and 52, 24 weeks post-treatment
To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion	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	Visit 2 (week 1)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026