Status:
COMPLETED
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
Lead Sponsor:
Novartis
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
20-69 years
Phase:
PHASE1
Brief Summary
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients
Eligibility Criteria
Inclusion
- Have a clinical diagnosis of CHC established on the basis of a detectable viral load as measured by a serum HCV RNA test at least 6 months before and during the screening period.
- Age 20 to 69 years
- Have compensated liver disease results on screening laboratory assessment
Exclusion
- Evidence of decompensated liver disease and/or liver cirrhosis.
- Body weight \< 50 kg.
- A history of immunologically mediated disease.
- A history or other clinical evidence of interstitial lung disease
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00724776
Start Date
July 1 2008
Last Update
December 8 2020
Active Locations (1)
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1
Novartis Pharmaceuticals, Japan
Tokyo, Japan