Status:
COMPLETED
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine
Eligibility Criteria
Inclusion
- Male or female, at least 18 years of age.
- Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.
Exclusion
- Co-infection with HCV, HDV, or HIV.
- Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
- History of hepatic decompensation
- History of malignancy
- Patient has one or more additional known primary or secondary causes of liver disease
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00640588
Start Date
March 1 2008
End Date
December 1 2009
Last Update
March 28 2017
Active Locations (1)
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1
Novartis Investigative Site
Barcelona, Spain