NCT01121731

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

Phase I/II, Multicenter, Randomized, Open,Active-Controlled, ClinicalTrial to Evaluate PK, PD, Safety and Tolerability Of Interferon Alfa 5, S.C. 3 Times Per Week, For 29 Days, To Treat-Experienced Pat. With Genotype-1 Chronic Hepatitis C

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Digna Biotech S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C Virus Infection
• Genotype 1
• Treatment-Experienced Patients
• Relapses

Interventions

Type	Name	Description
DRUG	Interferon α-5	3 MIU or safe dose used three times a week (TIW) in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.
DRUG	Interferon-α5 plus Interferon-α 2b	Interferon-α5 plus Interferon-α 2b. 1.5 MIU each, or safe dose used TIW in alternate days in combined therapy. 29 days of treatment. Subcutaneous injection.
DRUG	Interferon α-2b (INTRON® A)	3 million IU TIW in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2010-05-12
• Last updated: 2013-02-05

Locations

15 sites across 1 country: Spain