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

NCT01121731 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-02-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Digna Biotech S.L.

    lead INDUSTRY

Principal Investigators

  • Jesús Prieto, MD, PhD · Clínica Universidad de Navarra. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121731 on ClinicalTrials.gov