Overview

A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate the antiviral efficacy and pharmacodynamics (PD) of such doses and drugs in treatment-experienced HCV patients with genotype 1 chronic infection, after 29 days of treatment. It is also intended to determine pharmacokinetics (PK) of the safe dose achieved of IFN-α5 in monotherapy.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Digna Biotech S.L.
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons