NCT01121731

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

Typical duration for phase_1

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

2.4 years

First QC Date

May 10, 2010

Last Update Submit

February 4, 2013

Conditions

Chronic Hepatitis C Virus InfectionGenotype 1Treatment-Experienced PatientsRelapses

Keywords

Chronic Hepatitis C Viral InfectionInterferon alfa-5Interferon

Outcome Measures

Primary Outcomes (1)

  • Safe dose level

    PRIMARY ENDPOINTS OF PHASE I * To determine if 3 MIU of IFN-α5 are well tolerated and if not, to find a safe dose level for IFN-α5. * To determine if 1.5 MIU of IFN-α5 in combination with 1.5 MIU of IFN-α2b (IFN-α5 + IFN-α2b) are well tolerated and if not, to find a safe dose level for the combination of IFN-α5 and IFN-α2b. PRIMARY ENDPOINTS OF PHASE II * To analyze IFN-α5 preliminary antiviral efficacy at the dose of 3 MIU, or the safe dose level identified in Phase I. * Primary safety endpoints: Occurrence of AE (classified into mild, moderate and severe)

    29 days of treatment

Secondary Outcomes (1)

  • pharmacodynamic and pharmacokinetic parameters

    29 days of treatment

Study Arms (3)

Interferon α-5

EXPERIMENTAL
Drug: Interferon α-5

Interferon α-5 plus Interferon α-2b

EXPERIMENTAL
Drug: Interferon-α5 plus Interferon-α 2b

Interferon α-2b (INTRON® A)

ACTIVE COMPARATOR
Drug: Interferon α-2b (INTRON® A)

Interventions

Interferon α-5DRUG

3 MIU or safe dose used three times a week (TIW) in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.

Interferon α-5
Interferon-α5 plus Interferon-α 2bDRUG

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.

Interferon α-5 plus Interferon α-2b
Interferon α-2b (INTRON® A)DRUG

3 million IU TIW in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.

Interferon α-2b (INTRON® A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥18 years old,
  • With chronic hepatitis C (CHC) infection diagnosed by seropositivity for anti-HCV antibodies or detectable HCV-RNA, at least 6 months prior to screening.
  • Patients with CHC infection of genotype 1 (1a, 1b or mixed 1a/1b)
  • Defined as relapsers: those CHC patients who had achieved virologic response (HCV-RNA non detectable) at any time during the standard care of treatment for CHC with IFN-α2 or PegIFN-α2 + ribavirin, and maintained it trough the end of treatment at week 48 weeks, but HCV-RNA detection occurs before 6 months post-treatment.
  • In whom liver cirrhosis has been ruled out through fibro-scan or liver biopsy within 24 months prior to study enrolment.
  • With a serum HCV viral load ≥ 100.000 IU/mL at screening
  • With alanine-aminotransferase (ALT) and aspartate-aminotransferase (AST) serum measurements at screening less than 5 times of their upper limits of normal (ULN)
  • With a body mass index (BMI) of at least 18 kg/m2, but not exceeding 36 kg/m2.
  • For female subjects with childbearing potential: use of a known highly effective method of birth control
  • For male subjects with partners of child bearing potential: use of appropriate contraceptive methods.
  • Is able to effectively communicate with the investigator and other testing center personnel.
  • Is able to participate and willing to give written informed consent and comply with the study restrictions.

You may not qualify if:

  • Hepatitis C infection of genotype 2, 3 or 4 or any mixed genotype (1/2, 1/3 and 1/4).
  • A positive ELISA for HIV-1 or HIV-2.
  • Hepatitis B virus (HBV) infection based on the presence of HBsAg.
  • Hepatitis A virus (HAV) infection based on the presence of antiHAV-IgM. (AM 4)Criteria deleted
  • Decompensated liver disease, or history of decompensated liver disease.
  • History or other evidence of a medical condition associated with decompensated renal, immunologically mediated, chronic pulmonary, cardiac, thyroid, severe retinopathy, severe psychiatric, organ transplantation, cancer, seizure disorder or pancreatitis diseases.
  • An active or suspected malignancy or history of malignancy within the last five years.
  • Patients with a documented drug and alcohol addiction free history of at least 12 months who are, in the opinion of the investigator unlikely to relapse, may be enrolled in the study.
  • Haemoglobin \<12.0g/dL for women, and \<13.0g/dL for men at screening.
  • White blood cell count \<2000 cells/mm3 at screening.
  • Absolute neutrophil count \<1500 cells/mm3 at screening.
  • Platelet count \<100.000 cells/mm3 at screening.
  • ALT and AST levels ≥ 5 xULN at screening.
  • Prothrombin time INR prolonged to 1.5xULN at screening.
  • TSH an T4 outside normal limits and not adequately controlled thyroid function at screening.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Centre 013

A Coruña, Spain

Location

Centre 004

Barcelona, Spain

Location

Centre 005

Barcelona, Spain

Location

Centre 008

Barcelona, Spain

Location

Centre 011

Barcelona, Spain

Location

Centre 014

Granada, Spain

Location

Centre 015

León, Spain

Location

Centre 002

Madrid, Spain

Location

Centre 003

Madrid, Spain

Location

Centre 006

Madrid, Spain

Location

Centre 009

Madrid, Spain

Location

Centre 016

Madrid, Spain

Location

Centre 001

Pamplona, Spain

Location

Centre 012

Santander, Spain

Location

Centre 010

Seville, Spain

Location

MeSH Terms

Conditions

Recurrence

Interventions

Introns

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • Jesús Prieto, MD, PhD

    Clínica Universidad de Navarra. Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

ES(15)