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    Summary
    EudraCT Number:2011-000263-27
    Sponsor's Protocol Code Number:IgPro10_4001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-08
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-000263-27
    A.3Full title of the trial
    An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).
    A.3.2Name or abbreviated title of the trial where available
    Privigen® in ITP
    A.4.1Sponsor's protocol code numberIgPro10_4001
    A.5.4Other Identifiers
    Name:--Number:--
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCSL Behring LLC
    B.1.3.4CountryUnited States
    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 supportCSL Behring GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring GmbH
    B.5.2Functional name of contact point(Babette von Hagen) Senior CRA
    B.5.3 Address:
    B.5.3.1Street AddressEmil-von-Behring-Straße 76
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35041
    B.5.3.4CountryGermany
    B.5.4Telephone number496421396763
    B.5.5Fax number496421392870
    B.5.6E-mailbabette.vonhagen@cslbehring.com
    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 Privigen®
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    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.3.1Product namePrivigen®
    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 G (IgG > 98% purity)
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN
    D.3.9.4EV Substance CodeSUB14196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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
    Chronic immune thrombocytopenic purpura (ITP)
    E.1.1.1Medical condition in easily understood language
    The condition of having a low platelet count (thrombocytopenia) of no known cause (idiopathic)
    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 15.0
    E.1.2Level PT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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 of this study is to investigate the specificity of in vivo antibody binding to red blood cells
    (RBCs) in 10 subjects with chronic ITP who have shown signs of hemolysis and who experience clinically
    significant intravascular hemolytic reactions following treatment with IgPro10. The study will explore potential
    mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess other safety and efficacy parameters, including the rates of presumptive
    hemolytic events and clinically significant intravascular hemolytic reactions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of chronic ITP defined by:
    - Failure to find other causes of thrombocytopenia,
    - Platelet count of ≤ 150 x 109/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months;
    • Age of 18 to 65 years;
    • Platelet count of ≤ 30 x 109/L at screening;
    • Written informed consent for study participation obtained before undergoing any study specific procedures.
    E.4Principal exclusion criteria
    • Planned splenectomy throughout the study period;
    • Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening;
    • Drugs that have any pharmacological effect on the blood clotting system within 3 weeks prior to screening
    (i.e., clotting factors, heparin, coumarin derivates, acetylsalicylic acid in high dose, and thrombopoietin receptor agonists [e.g., eltrombopag and romiplostim]);
    • Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. aseptic meningitis, recurrent severe headache, hypersensitivity, intravascular hemolysis);
    • Known hyperprolinemia;
    • Abnormal results in the following laboratory parameters at screening:
    - Hemoglobin < 11 g/dL,
    - Positive DAT,
    - Indirect bilirubin > the upper limit of the normal range (ULN),
    - Serum free haptoglobin < 0.2 g/L,
    - LDH > ULN,
    - Alanine aminotransferase (ALAT) > 2.5 x ULN,
    - Aspartate aminotransferase (ASAT) > 2.5 x ULN,
    - Creatinine > 1.5 x ULN,
    - Reticulocyte count > 1.5 x ULN,
    - Iron < 50% of LLN, ferritin < 50 LLN, vitamin B12 < 50% of LLN;
    • Pregnancy, lactation, or planned pregnancy;
    • RBC transfusion or erythropoietin treatment within the last 14 days;
    • One of the following concomitant diseases:
    - Clinically active systemic lupus erythematosus,
    - Known or suspected HIV infection,
    - Acute hepatitis,
    - Clinically active chronic hepatitis,
    - Lymphoproliferative disease,
    - Sickle cell disease,
    - New York Heart Association (NYHA) grade III or IV heart failure;
    • Febrile illness or acute infection between screening and Day 1 (to be checked on Day 1 prior to dosing);
    • Body temperature ≥ 38°C at screening or prior to treatment on Day 1 (to be checked on Day 1 prior to dosing);
    • History of Evan’s syndrome;
    • Participation in another clinical study during the last 3 months;
    • Alcohol, drug, or medication abuse within one year before the study;
    • Re-entry of subjects previously treated in the present study;
    • Re-screening within 4 weeks after the preceding screening;
    • Suspected inability (e.g., language problems) or unwillingness to comply with study procedures;
    • Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to
    understand the nature, scope and possible consequences of the study) ;
    • Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study;
    • Employee at the study site, or spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the set of antibodies most frequently bound to RBCs in subjects experiencing clinically significant intravascular hemolysis. The presumptive hemolysis cases will be adjudicated by an independent Adjudication Committee to determine if the hemolysis represents clinically significant intravascular hemolysis. Most frequent antibodies are defined as those antibodies that are identified at day 3 as binding specific red cell antigens (determined using an antigen panel) in at least 4 subjects (out of 10 with clinically significant hemolysis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continously
    E.5.2Secondary end point(s)
    Subjects with a platelet response (PR) defined as subjects having a platelet count increases at least once to ≥ 50 x 109/L within 6 days after the first infusion (i.e., up to and including Day 7).
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 days after the first infusion
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Serbia
    Turkey
    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
    Last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 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.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 150
    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)
    The patients' treatment/care will not change after they finish their participation in this study.
    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 Decision2011-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-17
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