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    Summary
    EudraCT Number:2007-003642-15
    Sponsor's Protocol Code Number:Belimumab bei ITP
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-01-24
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2007-003642-15
    A.3Full title of the trial
    A Randomized, Double-blind Superiority Trial to Evaluate the Safety, Tolerability, and Efficacy of Belimumab in Refractory ITP Subjects
    A.4.1Sponsor's protocol code numberBelimumab bei ITP
    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 SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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.2.1.1.1Trade name Belimumab (LyphoStat-B-TM Antibody)
    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 nameBelimumab
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Yes
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autoimmune thrombocytopenia (ITP) is a common disorder in which platelets are destroyed by autoantibodies.
    BAFF has been shown to be elevated in the serum of ITP patients. Blockage of BAFF has been shown to be efficient in other autoimmune diseases.
    Here, we want to investigate the efficiency and tolerability of Belimumab in the treatment of patients with ITP.


    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of belimumab in refractory ITP subjects when administered every 4 weeks to adult patients with chronic ITP.

    E.2.2Secondary objectives of the trial
    To assess the impact of Belimumab on the incidence and severity of symptoms of thrombocytopenia compared to standard treatment when administered every 4 weeks to adult patients with chronic ITP.

    To assess the impact of Belimumab on the equality of life when administered every 4 weeks to adult patients with chronic ITP.

    To assess the impact of Belimumab on the plasma levels of soluble BAFF in adult patients with chronic ITP.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age 18 – 70 years
    •Gender: male or female
    •Diagnosed ITP for at least 6 months prior to screening, and have a platelet count of <30.000 platelets/mikroliter on Day 1.
    •Refractory patients who have either not responded to one or more prior therapies, or have relapsed within 3 months prior therapy. Previous therapies include corticosteroids, IVIG, anti-D immunoglobulin, azathioprine, danazol, cyclophosphamide, immunomodulators and/or splenectomy. Previous therapies with immunoglobulins, immunomodulators and cyclophosphamide must have been completed at least two weeks prior to randomization.
    •Subjects with maintenance immunosuppressive therapy (corticosteroids, azathioprine, danazol, cyclosporine A, MMF) and inadequate increase of platelets (<30,000/mikroliter).
    •Subjects treated with maintenance immunosuppressive therapy (corticosteroids, danazol, cyclosporine A) must be receiving a dose that has been stable for at least 1 month.
    •Normal protrombin time (PTT) and activated partial thromboplastin time (aPTT).
    •A complete blood count, reticulocyte count, creatinine, ALT, AST, bilirubin within the reference range with the following exceptions:
    •Platelet count < 30.000/mikroliter
    •Hemoglobin: female and male >= 10.0 g/dL are eligible for inclusion.
    •ANC>=1500/mikroliter is required for inclusion; elevated WBC/ANC due to steroid treatment is acceptable.
    •Subject is practicing an acceptable method of contraception (documented in chart). Female subject or female partners of male subjects must either be on non-childbearing potential (hysterectomy, bilateral, oophrenectomy, bilateral tube ligation or post-menopausal >=1 year).
    •Complete abstinence of intercourse
    •Intrauterine device
    •Two forms of barriers contraception
    •Male partner is sterile and the one partner of the female. Contraception: if subject is male – partner is sterile, if female – subject sterile.
    •Systemic contraceptives (combined or progesterone only)
    •Subject is able to understand and comply with the protocol requirements and instructions and intends to complete the study as planned
    E.4Principal exclusion criteria
    •History of thrombosis within the last year.
    •Pre-existing cardiac disease; myocardial infarction in the last three months
    •Female subjects who are nursing or pregnant (positive serum or urine
    •Subject has consumed aspirin, aspirin containing compounds, anti-coagulants or non-steroidal anti-inflammatories for > 3 consecutive days within 2 weeks during the study.
    •Any laboratory or clinical evidence for HIV, Hepatitis C, chronic Hepatitis B infection beta-chorionic gonatrotropin pregnancy test) at screening at pre-dose on Day 1.
    •History of alcohol/drug abuse or dependence within 12 months of the study.
    •Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
    •A complete blood count (CBC) and/or reticulocyte count outside the reference range , with the following exceptions:
    •Platelet count < 30.000/mikroliter is required for inclusion.
    •Haemoglobin: females and males >=10 g/dL are eligible for inclusion.
    •ANC>=1500/mikroliter (1.5 x 109/L) is eligible for inclusion.
    •History of platelet aggregation that prevents reliable measuring of platelet counts.
    •An laboratory or clinical evidence for HIV infection; an clinical history or laboratory evidence for hepatitis C infection; an clinical history or laboratory evidence for hepatitis B infection; or any evidence for active hepatitis at the time of subject screening; if the potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however standard medical practice would suggest evaluation of patients who have risk factors for these infections.
    •Persons who are detained officially or legally to an official institute
    •Women of childbearing age without highly effective contraception (PEARL-Index < 1%)
    E.5 End points
    E.5.1Primary end point(s)
    - Platelet count after 56 days of therapy with belimumab
    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 No
    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 Information not present in EudraCT
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    The recruitment period will last 12 months. The total duration of the study is 18 months. The end of the trial is reached when the last patient has undergone the last study 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 months6
    E.8.9.1In the Member State concerned days0
    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) Yes
    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 state21
    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 Decision2008-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-11-03
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