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

Phase 4

Completed

• Conditions: Compensated Chronic Hepatitis B
• Interventions: Drug: telbivudine/LDT600

• Registration Number: NCT00877149
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2011-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	telbivudine/LDT600	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (4)

Beijing Ditan Hospital; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Peking, China

First Hospital of Peking University; 🇨🇳 Peking, China

Ruijin Hospital, Affiliated to 2nd Medical university; 🇨🇳 Shanghai, China