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    The EU Clinical Trials Register currently displays   41198   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2018-000588-99
    Sponsor's Protocol Code Number:BLU-285-2203
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-05
    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 number2018-000588-99
    A.3Full title of the trial
    A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis with Symptoms Inadequately Controlled with Standard Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Avapritinib in Patients with Indolent and Smoldering Systemic Mastocytosis
    A.3.2Name or abbreviated title of the trial where available
    PIONEER
    A.4.1Sponsor's protocol code numberBLU-285-2203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03731260
    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 SponsorBlueprint Medicines Corporation
    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 supportBlueprint Medicines Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyneos Health, LLC
    B.5.2Functional name of contact pointProject Director, Global Oncology
    B.5.3 Address:
    B.5.3.1Street Address1030 Sync Street
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1512904 4317
    B.5.6E-mailsara.hoffman@syneoshealth.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2074
    D.3 Description of the IMP
    D.3.1Product nameAvapritinib
    D.3.2Product code BLU-285, C-366, C366, 70C366, X720776, BLU112317
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAvapritinib
    D.3.9.2Current sponsor codeBLU-285
    D.3.9.4EV Substance CodeSUB178877
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2074
    D.3 Description of the IMP
    D.3.1Product nameAvapritinib
    D.3.2Product code BLU-285, C-366, C366, 70C366, X720776, BLU112317
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAvapritinib
    D.3.9.2Current sponsor codeBLU-285
    D.3.9.4EV Substance CodeSUB178877
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Indolent and Smoldering Systemic Mastocytosis (ISM & SSM)
    E.1.1.1Medical condition in easily understood language
    Mastocytosis
    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 PT
    E.1.2Classification code 10042949
    E.1.2Term Systemic mastocytosis
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10056452
    E.1.2Term Indolent systemic mastocytosis
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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
    Part 1 - to determine the RP2D in patients with ISM for use in Part 2 and Part 3 of the study.
    Part 2 - to determine the effect of avapritinib in reducing symptoms in ISM and SSM patients, as compared to placebo.
    Part 3 - to assess the long-term safety and efficacy of avapritinib in ISM and SSM patients.
    E.2.2Secondary objectives of the trial
    Part 1 and Part 2, assess:
    Change in measures of MC burden, cutaneous disease and BSC usage; Change from baseline to wk 12 for ISM-SAF "lead symptom" score, proportion of patients with and time to achieve 5, 10 and 15-pt reductions in TSS and domain scores, and change in individual symptom scores; Change in other PROs based on the MC-QoL, PGIS, SF-12, PGIC and the EQ 5D-5L questionnaires; Change in the frequency of anaphylactic episodes; Safety and tolerability of avapritinib, as assessed by AEs, vital signs, ECGs and lab tests; PK of avapritinib; Correlate exposure with safety and efficacy endpoints

    Part 3, assess:
    Change in the measures of MC burden, cutaneous disease and BSC usage; Change in ISM-SAF "lead symptom" score, TSS, domain scores and individual symptom from Part 3 baseline to wk 12, 24, 36 and 52; Time to achieve those reductions; Change in other PROs as in part 2; Change in the frequency of anaphylactic episodes; Safety and tolerability of avapritinib, as in part 2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who are ≥ 18 years of age.
    2. Patient must have SM, confirmed by Central Pathology Review of BM biopsy, and ISM or SSM subtype, as confirmed by WHO diagnostic criteria. In Part 1 of the study, only patients with a diagnosis of ISM are eligible.
    3. Patient must have moderate-to-severe symptoms based on minimum mean TSS over the 14-day eligibility screening period for assessment of TSS and ≥ 1 symptom in skin or GI domains of the ISM-SAF at Baseline. Minimum TSS for eligibility is ≥ 28.
    4. Patient must have failed to achieve symptom control for 1 or more Baseline symptoms measured by ISM-SAF, as determined by the Investigator, with at least 2 of the following symptomatic therapies administered at optimal (approved) dose and for a minimum of 28 days before starting the ISM-SAF for determination of eligibility: H1 blockers, H2 blockers, proton-pump inhibitors, leukotriene inhibitors, cromolyn sodium, corticosteroids, or omalizumab.
    5. Patient must have symptom management optimized with symptomatic therapies (eg, H1 and H2 blockers) and the dose must be stable for ≥ 14 days before starting the ISM-SAF for determination of eligibility.
    6. If the patient is receiving corticosteroids, the dose must be ≤ 20 mg/d prednisone or equivalent, and the dose must be stable for ≥ 14 days before starting the ISM-SAF for determination of eligibility.
    7. Patient must have an Eastern Cooperative Oncology Group Performance Status of 0 to 2.
    8. Patient must give written informed consent.
    E.4Principal exclusion criteria
    1. Patient has been diagnosed with any of the following WHO SM subclassifications: CM only, SM-AHN, ASM, MCL, MC sarcoma.
    2. Patient has been diagnosed with another myeloproliferative disorder.
    3. Patient has any of the following organ damage C-findings attributable to SM: Cytopenia, Hepatomegaly with ascites and impaired liver function, Palpable splenomegaly with hypersplenism, Malabsorption with hypoalbuminemia and significant weight loss, Skeletal lesions: large osteolytic lesions with pathologic fractures, Life-threatening organ damage in other organ systems that is caused by MC infiltration in tissues.
    4. Patient meets any of the following laboratory criteria: Aspartate aminotransferase or alanine aminotransferase > 3.0 × ULN, Total bilirubin > 1.5 × ULN; > 3.0 × ULN if due to Gilbert's disease, Albumin < 1 × LLN, eGFR < 30 mL/min/1.73 m^2 or creatinine clearance calculated by Cockcroft-Gault equation < 40 mL/min, Absolute neutrophil count < 1.5 × 10^9/L, Hemoglobin < 10 g/dL, Platelet count < 100 × 10^9/L.
    5. Patient has received any of the following medications, therapies, or procedures in the timeframes listed: Any prior treatment with avapritinib, Any TKI, including but not limited to masitinib and midostaurin, or investigational agent < 14 days before starting the ISM-SAF for determination of eligibility, Any antineoplastic drug therapy < 28 days before starting the ISM-SAF for determination of eligibility, Radiotherapy or psoralen and ultraviolet A (PUVA) therapy < 14 days before starting the ISM-SAF for determination of eligibility, Any hematopoietic growth factor < 14 days before starting the ISM-SAF for determination of eligibility, Any major surgical procedure < 14 days before starting the ISM-SAF for determination of eligibility.
    6. Patient requires therapy with a concomitant medication that is a strong inhibitor, strong inducer, or moderate inducer of cytochrome P450 3A4 (CYP3A4).
    7. Patient has a history of a malignancy that has been diagnosed or required therapy within 3 years before the first dose of study drug. The following are exempt from the 3-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.
    8. Patient has a QTcF > 450 msec.
    9. Patient has a history of a seizure disorder (eg, epilepsy) or requires antiseizure medication.
    10. Patient has a history of a cerebrovascular accident or transient ischemic attacks within 12 months before the first dose of study drug.
    11. Patient has a known risk or recent history (12 months before the first dose of study drug) of intracranial bleeding (eg, brain aneurysm).
    12. Patient has a primary brain malignancy or metastases to the brain.
    13. Patient has clinically significant, uncontrolled cardiovascular disease, including Grade III or IV congestive heart failure according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months; clinically significant, uncontrolled arrhythmias, or uncontrolled hypertension.
    14. Patient is unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures, including mandatory BM and skin biopsies, and study restrictions.
    15. Female patients who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during the study drug administration period and for at least 30 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during the study drug administration period and for at least 90 days after the last dose of study drug.
    16. Pregnant women, as documented by a β-hCG pregnancy test consistent with pregnancy obtained within 7 days before the first dose of study drug. Women with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written approval of the Sponsor after pregnancy has been excluded. Women of nonchildbearing potential (postmenopausal, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) do not require a serum β-hCG pregnancy test.
    17. Women who are breast feeding.
    18. Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the patient, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results.
    19. Patient is illiterate or otherwise unable or unwilling to complete daily ISM-SAF assessments in the eDiary. Patient must be fluent in the language(s) available for the ISM-SAF and other QoL questionnaires.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1 - RP2D in patients with ISM.
    Part 2 - mean change in ISM-SAF TSS.
    Part 3 - long-term safety and efficacy of avapritinib.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1 - weekly for the first 4 weeks, then every 4 weeks
    Part 2 - from Baseline to Week 12
    Part 3 - weekly for 4 weeks, then every 4 weeks for 5 months, and then every 3 months, for a total of 2 years from C1D1; patients still on study after 2 years will have visits every 6 months (24 weeks) for a total study duration of 5 years, inclusive of Part 1 and Part 2
    E.5.2Secondary end point(s)
    Part 1 and Part 2
    • Change in measures of MC burden:
    o Serum tryptase.
    o KIT D816V allele burden in blood.
    o BM MCs.
    o Skin MCs in patients with baseline CM.
    • Change in percent body surface area (BSA) involved by CM and change in pigmentation of cutaneous lesions in patients with baseline CM.
    • Change in BSC concomitant medication usage.
    • Change in "lead symptom" score of ISM-SAF from Baseline to Week 12.
    • Proportion of patients with at least 5-point, 10-point, and 15-point reductions in TSS and domain scores of ISM-SAF from Baseline to Week 12.
    • Time to achieve 5-point, 10-point, 15-point, and maximum reductions in TSS and domain scores of ISM-SAF.
    • Change in domain scores and individual symptom scores of ISM-SAF from Baseline to Week 12.
    • Change in MC-QoL, PGIS, SF-12, PGIC, and EQ-5D-5L.
    • Change in number of episodes of anaphylaxis, based on epinephrine use.
    • Safety and tolerability of avapritinib, as assessed by AEs, vital signs, ECGs, and laboratory tests.
    • Pharmacokinetics of avapritinib.
    • Correlations between avapritinib exposure and safety and efficacy endpoints.

    Part 3
    • Change in the following measures of MC burden:
    o Serum tryptase.
    o KIT D816V allele burden in blood.
    o BM MCs (optional).
    o Skin MCs in patients with baseline CM (optional).
    • Change in BSA involved by CM and change in pigmentation of cutaneous lesions in patients with baseline CM.
    • Change in BSC concomitant medication usage.
    • Change in "lead symptom" score of ISM-SAF.
    • Change in TSS, domain scores, and individual symptom scores of ISM-SAF from Part 3 baseline (and from Part 1 and Part 2 baseline for patients receiving same dose of avapritinib in both study parts) to Weeks 12, 24, 36, and 52.
    • Time to achieve 5-point, 10-point, and 15-point, and maximum reductions in TSS and domain scores of ISM-SAF from Part 3 baseline (and from Part 1 and Part 2 baseline for patients receiving same dose of avapritinib in both study parts).
    • Changes in MC-QoL, PGIS, SF-12, PGIC, and EQ-5D-5L.
    • Change in number of episodes of anaphylaxis, based on epinephrine use.
    • Safety and tolerability of avapritinib, as assessed by AEs, vital signs, ECGs, and laboratory tests.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Tryptase: Screening, every visit through C3D8 (P1-2); every visit (P3)
    •KIT D816V allele burden: Screening, C1D1/D15, C2D1, C3D8 (P1-2), every 4W until P3 (P1); C1D1, C3D1, every 12W during C6-25, every 24W during C26 through end of study (P3)
    •BM & skin biopsy: Screening, between C3D8 & D15 (P1-2); optional at W52 (P3)
    •Skin photo: Screening, between C3D8 & D15, every 12W until W52 in P3
    •ISM-SAF: daily from baseline to W12 (P1-2); from P3 baseline to W12/24/36/52
    •QoL: each visit through P3 W52
    •Anaphylaxis episode: Screening, throughout study
    •AE & BSC: throughout study
    •Vital signs, hematology & chemistry: every visit until EOT
    •ECG: Screening, C1D1, C2D1, C3D8 (P1-2), between C3D8 & D15, D1 of every C (P1); D1 of every P3 visit
    •PK: before & after study drug dosing (P1-2)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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.8.2.4Number of treatment arms in the trial4
    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 EEA14
    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
    Belgium
    Canada
    Denmark
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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
    The end of the study is defined as the time that the last patient completes his/her last visit (LPLV), including assessments performed as part of safety follow-up.
    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 months7
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 112
    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)
    Normal standard of care.
    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 Decision2018-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
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