Chronic Hepatitis C
Conditions
Keywords
Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
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
Interventions
BIOLOGICALAlbinterferon alfa 2b
recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
Sponsors
Novartis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
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. * Age 20 to 69 years * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability after single dose | 5 weeks after single dose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation | 5 weeks after single dose |
Countries
Japan
Outcome results
None listed