Status:
COMPLETED
EFFicacy Optimization Research of Telbivudine Therapy
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Major Science and Technology Special Project of China Eleventh Five-year
Novartis
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
Eligibility Criteria
Inclusion
- Male or female, from 18 (inclusive) to 65 (inclusive) years of age
- HBsAg and HBeAg positive for over six months
- Patient is willing and able to comply with the study drug regimen and all other study requirements
- Patients must give written informed consent before any assessment is performed
Exclusion
- Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
- Patient has a history of or clinical signs/symptoms of hepatic decompensation
- Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT00962533
Start Date
August 1 2009
End Date
August 1 2012
Last Update
January 31 2013
Active Locations (24)
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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