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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-018146-38
    Sponsor's Protocol Code Number:MFN09/15
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-03-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2009-018146-38
    A.3Full title of the trial
    Multicenter randomized controlled study comparing the efficacy and safety of natural Multi-subtype interferon alpha (Multiferon) in association with ribavirin versus retreatment with pegylated interferon-alpha 2a and ribavirin in non-responding genotype 1 hepatitis C patients.
    A.3.2Name or abbreviated title of the trial where available
    Must Have
    A.4.1Sponsor's protocol code numberMFN09/15
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSwedish Orphan International AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Multiferon
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan International AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeA biological product containing purified human leukocyte interferon alpha. The interferon is produced in human leukocytes after addition of Sendai virus.
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeProduced by recombinant DNA technology
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeSynthetic nucleoside analog
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatitis C
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of natural Multi-subtype interferon-alpha (Multiferon) 6 MIU per day in combination with ribavirin (Copegus) to a retreatment with pegylated interferon-alpha 2a and ribavirin in non-responding genotype 1 hepatitis C patients as measured by the proportion of patients reaching complete viral response (undetectable viral load) after 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of natural Multi-subtype interferon-alpha (Multiferon) 6MIU per day in association with ribavirin (Copegus) to a retreatment with pegylated interferon-alpha 2a in the defined patient population:
    - On the reduction of the viral load at weeks 12 from baseline
    - On the proportion of patients reaching partial viral response (decrease of at least 2 log of the viral load) after 4, 8 and 12 weeks of treatment.

    The evaluation of the efficacy will also be performed in different subgroups, including:
    • Patients having reached complete clearance during their previous treatment with recombinant interferon (breakthrough patients)
    • Patients who never reached complete clearance during their previous treatment with recombinant interferon (non responders patients)
    • Patients having received at least 80% of the prescribed dose of study medication (defined as the Per Protocol population in the protocol)


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between 18 and 65 years of age
    2. Patient with documented genotype 1 chronic hepatitis C infection with detectable HCV RNA (> 25 IU/mL) in serum
    3. Previous non response to peg-interferon plus ribavirin treatment, defined as patients with documented response of at least a 1 log decrease of their viral load at week 12 to a prior course of SOC who did not achieve undetectable HCV-RNA at the end of treatment. Can be included both:
    3.1. Patient who had an undetectable HCV RNA level during prior course of Peg-IFN/ribavirin therapy but regained detectable HCV RNA before therapy ended (breakthrough patients);
    or
    3.2. Patients presenting, after 12 weeks of treatment with a viral decrease less than 2 log
    or
    3.3. Patients who did not achieve a negative viral load after 24 weeks of given treatment
    4. Well-documented previous SOC treatment with peg-interferon and ribavirin with HCV RNA levels measured at baseline, at week 12, and at the end of the treatment period.
    5. Patients who showed a compliance to previous treatment with peg-interferon and ribavirin of at least 80%
    6. Patient has had a liver biopsy and/or Fibroscan evaluation within 1 year prior to study inclusion showing a metavir score of F3 or less or less than 10 kPA.
    7. Screening laboratory values of the following variables must meet the acceptable values defined below: Laboratory Variable Acceptable Range
    • Absolute neutrophil count ≥ 1500/mm3
    • Platelet count ≥ 100000/mm3
    • Haemoglobin ≥ 12 g/dL for females ≥ 13 g/dL for males
    • Creatinine clearance > 50 ml/min
    • Uric acid within normal range
    • All other hematology and clinical chemistry results (except for transaminases) within normal limits or showing no clinically significant abnormalities
    8. All fertile males must accept effective contraception for both themselves and their partners during treatment and during 7 months after the treatment ends and for the female partners to undergo pregnancy tests monthly during the same period. .
    9. All fertile females must accept effective contraception for both themselves and their partner during treatment and during 4 months after the treatment ends and to undergo pregnancy tests monthly during the same period.
    10. Patient is able to read and understand, and is willing to sign the Informed Consent Form (ICF) voluntarily before first trial-related activity
    11. Patient agrees to not participate in other clinical trials
    E.4Principal exclusion criteria
    1. Patients having an hypersensitivity to interferon-alpha or ribavirin or any of the excipients used in Multiferon, Copegus or Pegasys
    2. Patient having intolerance or side effects during previous peg-interferon plus ribavirin treatment leading to discontinuation of at least one of the two drugs
    3. Women who are pregnant, planning to become pregnant, or breastfeeding, and males whose partner plans to become pregnant
    4. Patients having been treated by immunosuppressive agents within 6 months
    5. Patients having received HCV antiviral drugs or any investigational drug within 12 weeks prior to study inclusion
    6. Patient having an history of organ transplants that requires chronic immunosuppression
    7. Epilepsy if not well controlled by conventional medication
    8. Patients co-infected with HIV and/or hepatitis B
    9. Suspicion of alcohol, barbiturate, or amphetamine recreational or of narcotic drug use, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with study procedures
    10. Patient has a concomitant medical condition that in the opinion of the investigator could influence the results of the trial or that could represent an additional risk for the administration of the study drugs to the subject
    11. Patient has medical contraindication to the administration of Peg-IFN alfa-2a or ribavirin, including, but not limited to:
     abnormal thyroid function not controlled effectively with conventional treatment;
     history of clinically significant pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous 6 months
     evidence of autoimmune disease;
     history of hemoglobinopathies(e.g. thalassemia, sickle-cell anaemia).
    12. Pre-existing psychiatric condition that could interfere with the patient’s participation and completion of the study, including but not limited to:
     severe depression or hospitalization for depression;
     history of severe depression during the previous treatment with pegIFN and ribavirin
     schizophrenia, bipolar illness, severe anxiety or personality disorder;
     a period of disability or impairment due to a psychiatric disease within the past 5 years.
    13. Subject has history of decompensated liver disease: history of ascites,hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results:
     International Normalized Ratio (INR) of ≥ 1.5;
     Serum albumin < 3.3 g/dL;
     Serum total bilirubin > 1.8 times the upper limit of normal (ULN), unless isolated and for subjects with Gilbert’s Syndrome.
    14. Any evidence of significant liver disease in addition to hepatitis C, which may include, but is not limited to, hepatitis B virus (HBV) infection, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, or primary biliary cirrhosis.

    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients reaching complete early viral response (EVR) after 12 weeks of treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study, patients in the Multiferon arm with at least a 2 log decline of HCV RNA levels from baseline will be eligible for inclusion in a follow-up study. Further management of all other patients is under the discretion of the investigator.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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