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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00877149

First received: April 6, 2009

Last updated: May 3, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 6, 2009

Last Updated Date

May 3, 2012

Start Date ^ICMJE

March 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00877149 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion [ Time Frame: weeks 24, 52 and 24 weeks post-treatment ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Compensated Chronic Hepatitis B

Intervention ^ICMJE

Drug: telbivudine/LDT600

Study Arm (s)

Experimental: A

Intervention: Drug: telbivudine/LDT600

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00877149

Other Study ID Numbers ^ICMJE

CLDT600ACN04E1

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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