Status:
UNKNOWN
3E Extension Study
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Major Science and Technology Special Project of China 12th Five-year
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.
Eligibility Criteria
Inclusion
- Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
- Subjects who are willing to participate the extension study.
Exclusion
- Subjects who could not compliance with the protocol judged by investigators
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01834508
Start Date
March 1 2013
End Date
December 1 2016
Last Update
June 19 2014
Active Locations (28)
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1
302 Military Hospital Of China
Beijing, Beijing Municipality, China
2
Beijing Ditan Hospita
Beijing, Beijing Municipality, China
3
Beijing Friendship Hospital Attached To The Capital Medical University
Beijing, Beijing Municipality, China
4
BeiJing YouAn Hospital ,Capital Medical University
Beijing, Beijing Municipality, China