Status:
COMPLETED
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with te...
Eligibility Criteria
Inclusion
- The patient has completed the previous CLDT600A2407 study and is able to immediately enter this extension study with no study drug discontinuation
- Patient is willing and able to comply with the study drug regimen and all other study requirements
- The patient is willing and able to provide written informed consent to participate in the extension study.
Exclusion
- Patient is pregnant or breastfeeding.
- Patient is co-infected with HCV, HDV, or HIV.
- History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00467545
Start Date
April 1 2007
End Date
September 1 2009
Last Update
June 23 2017
Active Locations (6)
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1
Novartis Investigative Site (705-035)
Daegu, South Korea
2
Novartis Investigative Site , (420-717)
Gyeonggi-do, South Korea
3
Novartis Investigative Site , (405-760)
Incheon, South Korea
4
Novartis Investigative Site , (136-705)
Seoul, South Korea