Status:
COMPLETED
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the ...
Eligibility Criteria
Inclusion
- Male or female 16 to 65 year of age
- Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
- Willing and able to comply with the study drug regimen
- Written informed consent before any assessment
Exclusion
- Patient has a history of/or clinical signs/symptoms of hepatic decompensation
- Patient has a history of HCC or findings suggestive of possible HCC
- Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
- History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
- Patient has received IFN or other immunomodulatory treatment with 12 months before screening
- Previous treatment history with NRTIs
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2010
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT00781105
Start Date
August 1 2008
End Date
September 16 2010
Last Update
February 23 2017
Active Locations (1)
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1
Novartis Investigative Site
Beijing, China