Status:
COMPLETED
Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Compensated Chronic Hepatitis B
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00877149
Start Date
March 1 2009
Last Update
May 4 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Ditan Hospital
Beijing, China
2
First Hospital of Peking University
Beijing, China
3
Peking University People's Hospital
Beijing, China
4
Ruijin Hospital, Affiliated to 2nd Medical university
Shanghai, China