Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Biological: Albinterferon alfa 2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00724776

CABF656A1202

Details and patient eligibility

About

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients

Enrollment: 30 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

Open-label treatment with albinterferon alfa 2b escalating single dose

Treatment:

Biological: Albinterferon alfa 2b