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    Summary
    EudraCT Number:2016-002784-34
    Sponsor's Protocol Code Number:NL69665.091.19
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-02-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002784-34
    A.3Full title of the trial
    Deferoxamine in Aneurysmal Subarachnoid Hemorrhage pilot trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of a chelator in patients with aneurysmal cerebral hemorrhage
    A.3.2Name or abbreviated title of the trial where available
    DASH trial
    A.4.1Sponsor's protocol code numberNL69665.091.19
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    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 supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointH. Boogaarts
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243615085
    B.5.6E-mailjeroen.boogaarts@radboudumc.nl
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointJMC van Dijk
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031050361 28 99
    B.5.6E-mailj.m.c.van.dijk@umcg.nl
    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 desferal
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDeferoxamine mesilate for injection
    D.3.4Pharmaceutical form Solution for injection
    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 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) 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 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
    patients with aneurysmal subarachnoid hemorrhage
    E.1.1.1Medical condition in easily understood language
    patients with cerebral bleeding due to an aneurysm
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10007936
    E.1.2Term Central nervous system aneurysms
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10022758
    E.1.2Term Intracranial aneurysm
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluating safety in patients with aneurysmal subarachnoid hemorrhage.
    and evaluationg the efficacy in preventing delayed cerebral ischemia.
    E.2.2Secondary objectives of the trial
    the occurrence of new cerebral infarcts found on CT scan or MR scan 2 weeks after start treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18-85 years old inclusive,
    Subarachnoid hemorrhage diagnosed by CT on admission,
    No history of possible traumatic origin of subarachnoid hemorrhage,
    Randomizable within 72 hours of subarachnoid hemorrhage,
    Saccular intracranial aneurysm proven by cerebral angiography or CTA,
    Surgical or endovascular obliteration is successfully performed,
    Able to obtain written informed consent from patient or surrogate.
    Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of randomization.
    E.4Principal exclusion criteria
    Pregnancy, as confirmed by routine urine test on admission,
    Abnormal renal function at time of randomization (GFR <60 mL/min)
    Elevated liver function test at time of randomization (AST > 45 U/L and ALT > 35 U/L.)
    History of liver disease or active liver disease, Active renal disease,
    Patients with low ferritine (<1000 ng/mL)
    Hypersensitivity to deferoxamine,
    Patient taking medication not recommended for concomitant use with deferoxamine as per the product label (e.g. high dose vit. C medication).
    Patients not able to complete the study follow-up.
    The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:tachypnea (respiratory rate>30), SpO2<95%, Obesity (BMI>30) Acidosis (pH<7.35), Hypoalbuminemia (albumin<3.5g/dL), Concurrent use of chemotherapy
    -Tachypnea (respiratory rate >30),
    -SpO2 <95%,
    -Obesity (BMI >30)
    -Acidosis (pH <7.35),
    -Hypoalbuminemia (albumin <3.5 g/dL),
    -Concurrent use of chemotherapy


    E.5 End points
    E.5.1Primary end point(s)
    the occurrence of IMP related adverse events
    Number of patients with abnormal renal function
    Number of patients with abnormal hepatic function
    Number of patients with discontinued medication
    number of patients with ARDS
    Anaphylaxis at any time point during DFO infusion
    the occurrence of DCI
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after start study, and 6 months
    E.5.2Secondary end point(s)
    number of patients with of delayed cerebral ischemia
    number of patients with new cerebral infarction at 2 weeks and at 6 months
    mRS after 6 months
    extended Glasgow Outcome Scale
    EQ-5D quality of life score after 6 months.
    any AE prolonging hospital stay, resulting in emergent medical therapy, or resulting in death, regardless of relationship to DFO.
    E.5.2.1Timepoint(s) of evaluation of this end point
    two weeks and 6 months.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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 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
    number of adverse events related to the IMP is judged above acceptable by DSMB
    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 months0
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Included subjects are patients with aneurysmal subarachnoid hemorrhage in good clinical grade (WFNS1-3). Despite the relatively good clinical grade patients may not be full aware. legal representatives are asked.
    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.4.2.2In the whole clinical trial 20
    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
    geen
    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 Decision2019-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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