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    Summary
    EudraCT Number:2007-002139-94
    Sponsor's Protocol Code Number:IPH1101-203
    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:2007-04-27
    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 number2007-002139-94
    A.3Full title of the trial
    Multiple dose Phase II study of IPH1101 in monotherapy or associated with a low dose of IL2 (2MIU) in non previously treated hepatitis C patients
    A.4.1Sponsor's protocol code numberIPH1101-203
    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 SponsorInnate Pharma
    B.1.3.4CountryFrance
    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 No
    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.3.1Product namePhosphostim 200
    D.3.2Product code IPH1101
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 876060-87-6
    D.3.9.2Current sponsor codeIPH1101
    D.3.9.3Other descriptive namebromohydrin pyrophosphate (BrHPP)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.IMP: 2
    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 Proleukin 18MUI
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma S.A.S. (Formerly holder Chiron France)
    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.3.1Product nameProleukin 18 MUI
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALDESLEUKIN
    D.3.9.1CAS number 110942024
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 typeRecombinant DNA product
    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
    Non previously treated Hepatitis C patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    The primary objective is to assess the effect on viral load of IPH1101 administered in monotherapy or in association with a low dose of IL2 (2 MIU) in naïve hepatitis C patients.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to:
    - Confirm the safety profile of the dose regimen in this population
    - Assess the impact on viral load clearance kinetics (timing and duration of antiviral response) of IPH1101 alone or in association with a low dose of IL2
    - Evaluate the biological activity: Gamma Delta T cells amplification, cytokines release, and soluble antiviral factors release (such as Serum neopterin, beta2 microglobulin) after IPH1101 in monotherapy or in association with IL2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent prior to any protocol-specific procedures
    2. Patient has hepatitis C genotype 1, 2, 3 or 4 diagnosed on the following criteria
    a. Positive HCV antibody
    b. Serum HCV RNA superior to >10 000 IU/ml
    3. HCV treatment naïve.
    4. At least one elevated ALT value since diagnosis of HCV infection
    5. No or mild liver fibrosis (as estimated by biopsy or non-invasive means within the last 6 months)
    6. Aged between 18 and 65 years
    7. At screening, Body Mass Index (BMI) within the range of > 18 and < 32 kg/m² at screening visit
    8. Adequate bone marrow, hepatic and renal function as follows:
    a. White blood cells (WBC) ≥ 4 x 109/L, neutrophils ≥ 2.5 x 109/L, lymphocytes ≥ 1000/µL
    b. Platelets ≥ 150 x 109/L,
    c. Haemoglobin ≥ 12 g/dL or 7.44 mmol/L,
    d. Total bilirubin ≤ 2 x upper limit normal (ULN) and transaminases (AST/SGOT, ALT/ SGPT) ≤ 5 x ULN
    e. GGT ≤ 3 x ULN
    f. Serum Creatinin ≤ 2 x ULN
    9. Negative serology for hepatitis B surface antigen and HIV antibody
    10. QTc (Bazett’s correction) interval duration < 430 ms for men, < 450 ms for women
    11. Subject affiliated to the French Social Security
    12. Patients (male and female) who accept and are able to use recognised highly effective contraception methods (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) throughout the study and up to 12 months after last dose of study drug, if applicable.
    E.4Principal exclusion criteria
    1. Patients who received any antiviral treatment within 6 months preceding the inclusion in the study
    2. Patients having any organ transplantation and/or having received immunosuppressor treatment such as corticosteroids, cyclosporine and derivative within the last 30 days
    3. Pregnant or lactating women
    4. Any known hypersensitivity to one of the study treatments
    5. Patients having any following abnormality:
    a. Known auto immune disease: positive result on any anti-DNA, anti-tissue, anti-thyroglobulin, anti-microsome, anti-TSH receptor, anti-thyroperoxidase
    b. Abnormality of free T4 or TSH assay
    6. Current other active infection; serious concurrent, uncontrolled medical disorder such as diabetes, autoimmune disease
    7. Cardiovascular disease:
    a. Stage III or IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. Note: patients with NYHA stage I or II CHF may be included provided they do not have arrhythmia requiring treatment or fulfil any other exclusion criteria
    b. Myocardial infarction within the previous 6 months, or
    c. Symptomatic cardiac arrhythmia requiring treatment
    8. Major surgery within the 4 weeks preceding screening
    9. History of general anaesthesia within the previous 30 days before the request for randomisation
    10. Concomitant treatment with bisphosphonates, methadone or buprenorphine within the 30 days preceding screening or planned during the study
    11. Evidence of alcohol abuse (> 25 units per week) within 12 months prior to the request for randomisation or by a positive alcohol breath test or patients who have consumed alcohol within the 48 hours prior to the first dose of study medications, and/or are unwilling to abstain from these products while on study
    12. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
    13. Evidence of current intravenous drug toxicomania
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the viral load. Serum HCV RNA will be evaluated by a standardized reverse-transcription PCR. Viral load will be assessed by quantitative HCV RNA detection. Efficacy for this exploratory proof of concept study will be defined by response corresponding to a diminution of ½ log in viral load from baseline on at least one blood sample over 12 weeks.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Gene expression pattern of the HCV and HCV genotype
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Association versus monotherapy
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state28
    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 Decision2007-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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