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    Summary
    EudraCT Number:2011-001354-29
    Sponsor's Protocol Code Number:I10E-0719
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-06
    Trial results Removed from public view
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-001354-29
    A.3Full title of the trial
    An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)
    A.4.1Sponsor's protocol code numberI10E-0719
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/184/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLFB BIOTECHNOLOGIES
    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 supportLFB BIOTECHNOLOGIES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressZA de Courtaboeuf, 3, avenue des Tropiques
    B.5.3.2Town/ cityLes Ulis Cedex
    B.5.3.3Post code91940
    B.5.3.4CountryFrance
    B.5.4Telephone number+33169 82 70 10
    B.5.5Fax number+33169 82 72 72
    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 nameHUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
    D.3.2Product code I10E
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
    D.3.9.2Current sponsor codeI10E
    D.3.9.3Other descriptive namehuman Immunoglobulin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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.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
    ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
    E.1.1.1Medical condition in easily understood language
    treatment of Immune thrombocytopenia (a group of disorders characterized by autoimmune destruction of platelet and insufficient platelet production leading to an increased risk of bleeding)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10023095
    E.1.2Term ITP
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of I10E in increasing platelet count and controlling bleedings in patients suffering from primary Immune ThrombocytoPenia (ITP).
    E.2.2Secondary objectives of the trial
    To assess the biological and clinical safety profile of I10E.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Both genders

    2. Age between 18 to < 80 year old

    3. Chronic Primary ITP
    - ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009):
    ▪ Isolated thrombocytopenia diagnosed with platelet count
    <100 x 10exp9/l and no abnormality of cells of other haematological
    lineage and,
    ▪ Normal bone marrow (if available), or history of response to an
    ITP treatment (corticosteroids, IVIg, anti-D) and,
    ▪ Failure to find any other causes of thrombocytopenia.

    - Chronic ITP with bleeding(s) or an increased risk of bleeding:
    ▪ More than 12 months from diagnosis of ITP and,
    ▪ Platelet counts < 30 x 10exp9/l at the time of inclusion.
    Note: Refractory ITP may be included and is defined by the failure to achieve a response or by the loss of response after splenectomy and the need of treatment (s) to minimize the risk of bleeding considered as clinically
    significant by the investigator.

    4. Written informed consent.
    5. Patient is covered by health care insurance system.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to the active substance or to any of the excipients.

    2. Patient with IgA deficiency except if the absence of anti IgA antibodies is documented.

    3. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, or severe hypertension (systolic blood pressure > or = to160 mmHg and diastolic blood pressure > or = to 100 mmHg).

    4. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months in patients aged < 65 years and at any time in patients aged from 65 to 79 years.

    5. Patient known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.

    6. Treatment that could induce thrombocytopenia within 15 days prior to inclusion.

    7. Recent previous treatment, the action of which may interfere with the assessment of the investigational medicinal product:
    - Initiation of corticosteroids or regular increase in the steroid dose within the last 4 weeks (EMA/CHMP/BPWP/94033/2007 rev.2),
    - IVIg within the last 4 weeks,
    - Anti-D within the last 4 weeks,
    - Cyclosporin A within 4 weeks,
    - Immunomodulator (as vincristin, vinblastin) within the last month,
    - Immunosuppressor (azathioprine, cyclophosphamide) within the last 4 weeks,
    - Anti-CD20 (rituximab) within the last 4 months,
    - Antigonadotropin Hormone (danazol) within the last 6 months,
    - Thrombopoietin receptors agonist (eltrombopag, romiplostim) within the last 4 weeks,

    8. Splenectomy required during the study period or within the two previous months.

    9. Severe haemorrhagic syndrome whether life-threatening or not, such as intracranial haemorrhage, gastrointestinal haemorrhage, gynaecological
    haemorrhage with deglobulisation of more than 2g/dL or major cutaneous-mucosal haemorrhagic syndrome.

    10. Severe bleeding or planned surgery requiring platelets transfusion at time of inclusion, or whole blood transfusion.

    11. Plasma exchange 4 weeks before inclusion.

    12. Concomitant disease that may induce a secondary immune thrombocytopenia, as:
    - Clinical active systemic lupus erythematous with more than 4 American College of Rheumatology criteria,
    - Lymphoproliferative disease or active malignant condition requiring antineoplastic or cytotoxic treatment.

    13. Known hepatic disorder including total bilirubin > 2 x upper limit of normal range, alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 3 x upper limit of normal range.

    14. Prior episode of renal insufficiency or creatinine clearance values < 80 ml/min/1.73 m2 before inclusion (Modified Diet in Renal Disease calculation).

    15. Medical history of haemolysis or haemolytic anaemia during prior IVIg therapy or any other concomitant disease of clotting system (i.e. haemophilia).

    16. Administration of another investigational medicinal product within the last month.

    17. Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient to comply with the protocol requirements.

    18. Pregnant with positive results pregnancy urinary test or breastfeeding woman, or woman of childbearing potential without effective contraception (effective contraception are: injectable, patch or combined
    oral estro-progestative or progestative contraceptives, intra-uterine devices of type 'copper T' and levonorgest releasing IU systems, depot intramuscular medroxyprogesteron, subcutaneous implants of
    progestative contraceptives implants, barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the subject)).

    19. Anticipated poor compliance of patient with study procedures.

    20. Use of loop diuretics within a week prior the inclusion.

    21. History of alcohol or drug abuse.

    22. Previously included /enrolled in this clinical study.

    23. Body mass index >= 40 kg/m2.

    24. Risk factors for blood hyperviscosity such as cryoglobulinemia or hematologic malignancy with monoclonal gammapathy.

    25. History of congenital or acquired thrombphilia

    26. Factors contributing to venous stasis such as long-term bed confinement
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number and percentage of patients with responses (including complete responses) during the investigational period.

    Patients with response (R):
    - Platelet counts > or = to 30 x 10 exp9/l and at least 2-fold increase of baseline platelet count confirmed on at least 2 separate visits at least 7 days apart.
    - And absence of new bleeding.

    · Patients with complete response (CR):
    - Platelet count > or = to 100 x 10 exp9/l, confirmed on at least 2 separate visits at least 7 days apart.
    - And absence of new bleeding.
    E.5.1.1Timepoint(s) of evaluation of this end point
    confirmed on at least 2 separate visits at least 7 days apart during the study period.
    E.5.2Secondary end point(s)
    Efficacy criteria:
    - Number and % of patients with complete response (CR) during the investigational period.
    - Time to response i.e. time from starting treatment to time of platelet response achievement (platelet count > or = to 30 x 10 exp9/l) in the responder
    population.
    - Maximum platelet counts and time to reach the maximum platelet count.
    - Number and % of non-responders patients (NR) during the investigational period.
    - Number and % of patients with a loss of R and CR during the investigational period.
    - Duration of response defined as the number of days from the first day of the response (CR or R) to the first day of the loss of response (CR or R).
    - Number and % of patients with platelet count > or = to 50 x 10 exp9/l at Day 5, Day 6 and Day 7.
    - Evaluation of pre-existing bleedings (Khellaf score and WHO score assessed at baseline, Day 2, Day 14 and Day 30)
    E.5.2.1Timepoint(s) of evaluation of this end point
    see details provided in section E 5.2.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    Ukraine
    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
    End of the study will be last patient last visit
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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 last visit patients will be switched to the normal standard of care for the condition
    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 Decision2011-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-03
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