Hepatitis C
Conditions
Interventions
investigational material(s)
Generic name etc : Albinterferon alfa 2b
INN of investigational material :
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ages Eligible for Study : 20 years to 69 years Genders Eligible for Study : Both Inclusion Criteria -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 -IFN treatment-naive or treatment-experienced patients including combination therapy with Ribavirin -Have compensated liver disease results on screening laboratory assessment Exclusion Criteria -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 Other protocol-defined inclusion/exclusion criteria may apply
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes: Safety and tolerability after single dose Secondary Outcome: -Pharmacokinetics of albinterferon alfa 2b -HCV RNA and ALT as pharmacodinamics evaluation | — |
Outcome results
None listed