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

Compensated Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877149
• Other study ID #: CLDT600ACN04E1
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2009
• Last updated: May 3, 2012
• Start date: March 2009

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Compensated Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• telbivudine/LDT600

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing
China	First Hospital of Peking University	Peking
China	Peking University People's Hospital	Peking
China	Ruijin Hospital, Affiliated to 2nd Medical university	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion		weeks 24, 52 and 24 weeks post-treatment	No
Secondary	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)	No