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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

October 31, 2012

Study Completion Date

January 31, 2013

Conditions
Chronic Hepatitis C Virus InfectionGenotype 1Treatment-Experienced PatientsRelapses
Interventions
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.

Trial Locations (15)

Unknown

Centre 013, A Coruña

Centre 004, Barcelona

Centre 005, Barcelona

Centre 008, Barcelona

Centre 011, Barcelona

Centre 014, Granada

Centre 015, León

Centre 002, Madrid

Centre 003, Madrid

Centre 006, Madrid

Centre 009, Madrid

Centre 016, Madrid

Centre 001, Pamplona

Centre 012, Santander

Centre 010, Seville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Digna Biotech S.L.

INDUSTRY