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Chronic Hepatitis C Virus InfectionPhase 1/2NCT01121731

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

A Phase 1/2 study testing Interferon α-5, Interferon-α5 plus Interferon-α 2b and Interferon α-2b (INTRON® A) in people with Chronic Hepatitis C Virus Infection and Genotype 1, run by Digna Biotech S.L. at 15 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interferon α-5, Interferon-α5 plus Interferon-α 2b and Interferon α-2b (INTRON® A)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
15 sitesSpain
Study dates
May 2010to Jan 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Positive results for drug abuse at screening.Occasional use of cannabis previously to randomization is not an exclusion criteria -under investigator team criteria-. The patient should be advised of abstinence during the trial (AM 6)
  • 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.
  • Poorly controlled diabetes mellitus as evidenced by HbA1c >7.5% at screening.
  • Alfa-fetoprotein value >100ng/mL at screening.
  • Total bilirubin >1.5xULN with ratio of direct/indirect >1, at screening unless predominantly conjugated and reflecting Gilbert's disease
  • Estimated creatinine clearance of 30 mL/minute or less at screening.
  • Women who are confirmed to be pregnant
  • People with known hypersensitivity to any ingredient of the investigational agents
  • Patients who are at risk of bleeding.
  • Haemoglobinopathy
  • Screening ECG QTc value ≥ 450ms and/or clinically significant ECG findings.
  • History of clinically significant drug allergies.
  • Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration.
  • Any chronic viral (including HSV), bacterial, mycobacterial, fungal, parasitic, or protozoal infection.
  • Requirement for chronic systemic corticosteroids.
  • Receiving systemic antivirals, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrollment.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • 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

Other trials in Spain

About this study

Official title: 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

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.

Being tested
Interferon α-5, Interferon-α5 plus Interferon-α 2b, Interferon α-2b (INTRON® A)
Keywords
Chronic Hepatitis C Viral Infection, Interferon alfa-5, Interferon
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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-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-2b (INTRON® A)Drug

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

Study groups in NCT01121731
Study groupRoleWhat they receive
Interferon α-5ExperimentalNot described
Receives: Drug: Interferon α-5
Interferon α-5 plus Interferon α-2bExperimentalNot described
Receives: Drug: Interferon-α5 plus Interferon-α 2b
Interferon α-2b (INTRON® A)Active comparatorNot described
Receives: Drug: Interferon α-2b (INTRON® A)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 29 days of treatment

Secondary outcomes (1)

  1. pharmacodynamic and pharmacokinetic parameters

    SECONDARY ENDPOINTS OF PHASE I

    • To obtain pharmacokinetic parameters of IFN-α5 in monotherapy after single and multiple dose administration
    • To obtain pharmacodynamic parameters of IFN-α5 in monotherapy and in combination with IFN-α2b

    SECONDARY ENDPOINTS OF PHASE II

    • To analyze IFN-α5 + IFN-α2b preliminary antiviral efficacy and comparison between IFN-α5 in monotherapy, IFN-α5 + IFN-α2b and IFN-α2b in monotherapy.
    • To obtain pharmacodynamic parameters after treatment with IFN-α5, IFN-α5 + IFN-α2b or IFN-α2b.

    Measured: 29 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01121731
Sponsor's protocol ID
NAHE001-CHC-01
Other IDs
2009-012924-10, 2009
Status last verified
Feb 2013
First submitted
10 May 2010
Last updated
5 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Interferon α-5, Interferon-α5 plus Interferon-α 2b and Interferon α-2b (INTRON® A) in people with Chronic Hepatitis C Virus Infection and Genotype 1, run by Digna Biotech S.L. at 15 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safe dose level (time frame: 29 days of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01121731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.

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