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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2015-001035-20
    Sponsor's Protocol Code Number:PIPL002a
    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:2015-07-27
    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 number2015-001035-20
    A.3Full title of the trial
    Phase III, randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components (Capture).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III, randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components.
    A.3.2Name or abbreviated title of the trial where available
    Capture trial
    A.4.1Sponsor's protocol code numberPIPL002a
    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 SponsorDRK-Blutspendedienst NSTOB
    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 supportMacopharma
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportBlood services of the german red cross
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRK-Blutspendedienst NSTOB
    B.5.2Functional name of contact pointHead R&D
    B.5.3 Address:
    B.5.3.1Street AddressEldagsener Str. 38
    B.5.3.2Town/ citySpringe
    B.5.3.3Post code31832
    B.5.3.4CountryGermany
    B.5.4Telephone number+495041772455
    B.5.5Fax number+495041772184
    B.5.6E-mailAxel.Seltsam@bsd-nstob.de
    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 nameTheraflex UV-Platelets
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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) 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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeallogeneic human platelets
    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 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 nameUntreated plasma reduced platelet concentrates stored in SSP+additive solution
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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) 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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeallogeneic human platelets
    D.IMP: 3
    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 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 nameGamma-irradiated plasma reduced platelet concentrates stored in SSP+additive solution
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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) 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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeallogeneic human platelets
    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
    Thrombocytopenia
    E.1.1.1Medical condition in easily understood language
    Thrombocytopenia
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10043555
    E.1.2Term Thrombocytopenias
    E.1.2System Organ Class 100000004851
    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 the trial is to demonstrate the non-inferiority of UVC-treated plasma reduced platelet concentrates (UVC-PCs) in comparison to untreated plasma reduced platelet concentrates (Control-PCs) stored for up to 5 days in adult patients with hematologic or oncologic diseases and thrombocytopenia based on the 1 hour CCI of not more than 30% below the control.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objective:
    - To compare the post- transfusion PLT recovery, measured by platelet count increments
    (24 hour CCI, 1 hour and 24 hour CI) between treatment Groups;*
    - To compare PLT and RBC transfusions support between treatment Groups;*
    Secondary safety objective:
    - Rate of bleeding ≥ WHO grade 3 and grade 4;*
    - Rate of clinical refractoriness;*
    - Rate of immunologic refractoriness;*
    - Frequency of alloimmunization to neoantigens on PLTs;**
    - Rate of PLT transfusion-related adverse events (AEs) and serious adverse events (SAE).**

    * assessed during Treatment period only, ** assessed during Treatment and follow-up periods
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Haemato-oncological patients with thrombocytopenia or expected to become
    thrombocytopenic;
    - Expected to receive ≥ 1PLT transfusions during their hospital stay;
    - Age ≥ 18 years;
    - Written Informed Consent.
    E.4Principal exclusion criteria
    - Known immunological refractoriness to PLT transfusions, i.e. HLA and/or HPA
    alloimmunization (documented in the patient’s medical record);
    - History or diagnosis of an autoimmune disease affecting haemostasis;
    - Acute or chronic Disseminated Intravascular Coagulation (DIC);
    - History or diagnosis of Thrombotic Thrombocytopenic Purpura or Haemolytic Uremic Syndrome;
    - Severe uncontrolled infection;
    - Positive serum or urine pregnancy test;
    - Lactation;
    - Simultaneous participation in another interventional Trial;
    - Previous inclusion in this trial;
    - Acute promyelocytic leukemia (AML, FAB subtype M3)
    - Active bleeding at time of enrolment requiring one or more RBC transfusions and/or therapeutic platelet transfusions;
    - Splenomegaly defined as a palpable spleen felt more than 4 cm below costal margin;
    - History of severe anaphylactic transfusion criteria;
    - Legal incapacity or other circumstances preventing the patient from understanding the nature, meaning and implications of the clinical Trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is to demonstrate the non-inferiority of UVC-PCs in comparison to untreated or gamma-irradiated platelet concentrates (control PCs) assessed by the 1-hour CCI calculated for each PLT transfusion on a maximum of 8 PLT transfusions, stored for up to 5 days, per patient during the treatment period.
    Definition of the non-inferiority value: Up to a 30% reduction in CCI (test Group vs. controll) will be considered as not inferior.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On a maximum of 8 PLT transfusions per patient during the treatment period of max. 28 days
    E.5.2Secondary end point(s)
    - Mean 24-hour CCI, mean 1-hour CI and mean 24-hour CI calculated for each PLT transfusion on a maximum of 8 PLT transfusion;*
    - Mean number of PLT transfusion episodes and Units;*
    - Mean interval between PLT transfusions (days);*
    - Mean number of RBC transfusion episodes and Units;*
    - Rate of bleeding events ≥ WHO grade 3 and grade 4;*
    - Rate of clinical refractoriness defined as consecutive two consecutive transfusions with 1 hour CCI < 7.5;*
    - Rate of immunologic refractoriness defined as consecutive two consecutive transfusions with 1 hour CCI < 7.5 and serologic conversion to positive tests for HLA-and/or HPA alloantibodies or antibodies to UVC-related neoantigens;*
    - Frequency of alloimmunization to neoantigens on PLTs**
    - Rate of PLT transfusion-related adverse events (AEs) and serious adverse events (SAE).**

    * assessed during treatment period only; ** assessed during treatment and follow-up periods
    E.5.2.1Timepoint(s) of evaluation of this end point
    see remarks under E.5.2 secondary endpoints.
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days26
    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: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state166
    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)
    none
    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 Decision2016-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-11
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