Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Biological: Albinterferon alfa 2b
- Registration Number
- NCT00724776
- Lead Sponsor
- Novartis
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Albinterferon alfa 2b Open-label treatment with albinterferon alfa 2b escalating single dose
- Primary Outcome Measures
Name Time Method Safety and tolerability after single dose 5 weeks after single dose
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation 5 weeks after single dose
Trial Locations
- Locations (1)
Novartis Pharmaceuticals, Japan
🇯🇵Tokyo, Japan