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    Summary
    EudraCT Number:2012-002154-23
    Sponsor's Protocol Code Number:UKM_04_12_TCP_ATRA_AML
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002154-23
    A.3Full title of the trial
    Phase I/II pilot trial of ATRA (Tretinoin) and TCP (Tranylcypromine) in patients with relapsed or refractory acute myeloid leukemia (AML) when no intensive treatment is possible
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test the effect of Tranylcypromine (TCP) together with ATRA (Tretionin) in patients with acute myeloid leukemia (AML) when no intensive treatment is possible
    A.3.2Name or abbreviated title of the trial where available
    TCP-AML
    A.4.1Sponsor's protocol code numberUKM_04_12_TCP_ATRA_AML
    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 SponsorMartin-Luther-University Halle-Wittenberg
    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 supportDeutsche Krebshilfe
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Halle
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressErnst- Grube Strasse 40
    B.5.3.2Town/ cityHalle
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.4Telephone number+493455572924
    B.5.5Fax number+493455572848
    B.5.6E-mailcarsten.mueller-tidow@uk-halle.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 Yes
    D.2.1.1.1Trade name Jatrosom 10mg Filmtabeletten
    D.2.1.1.2Name of the Marketing Authorisation holderAristo Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameJatrosom 10mg
    D.3.4Pharmaceutical form 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 INNTRANYLCYPROMINE
    D.3.9.1CAS number 155-09-9
    D.3.9.4EV Substance CodeSUB11218MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 60
    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 Yes
    D.2.1.1.1Trade name Vesanoid 10mg Weichkapseln
    D.2.1.1.2Name of the Marketing Authorisation holderCHEPLAPHARM Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameVesanoid
    D.3.4Pharmaceutical form Capsule, soft
    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 INNTretinoin
    D.3.9.1CAS number 9009-81-8
    D.3.9.3Other descriptive nameTretinoin
    D.3.9.4EV Substance CodeSUB11246MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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: 3
    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 Jatrosom 20mg Filmtabeletten
    D.2.1.1.2Name of the Marketing Authorisation holderAristo Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameJatrosom 20mg
    D.3.4Pharmaceutical form 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 INNTRANYLCYPROMINE
    D.3.9.1CAS number 155-09-9
    D.3.9.4EV Substance CodeSUB11218MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 60
    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
    relapse or refractory AML in patients unfit for an intensive treatment
    E.1.1.1Medical condition in easily understood language
    refrctory acute myeloid leukemia or relapse of AML in patients who cannot tolerate an intensive chemotherapy
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analysis of the cumulative response rate (CR, CRp, CRi, PR) of all AML patients
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of repeated oral administration of Tretinoin and Tranylcypromin to patients with AML.
    • To assess the cumulative incidence and degree of histone methylation of promotor genes in AML blasts after treatment with Tretinoin and tranylcylpromine, and correlation with clinical reponse.
    • To compare in vivo treatment effects onto histone methylation levels and differentiation with TCP/ATRA effects in AML blasts exposed in vitro.
    • To assess overall survival (OS) in relationship to historical control patients
    • To determine the duration of response
    • Identification of molecular biomarkers that determine response to TCP/ATRA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of AML, and the subjects must be willing to comply with treatment and to follow up assessments and procedures
    2. Patients can be included with histologically or cytologically confirmed diagnosis of AML (except AML M3/ APL) in presence of relapsed after or refractory disease after at least one therapy regimen. Relapsed or refractory patients can be included into the clinical trial when no response to other therapy options can be expected or when intensive therapy in these patients cannot be administered. ,
    3. Age ≥ 18 years
    4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤3 (see Appendix, 3.2)
    5. Measurable disease burden (blasts in BM and/or PB, extramedullary blasts [chloroma])
    6. Able to swallow and retain oral medication
    7. A life expectancy of at least 4 weeks
    8. Adequate contraception methods
    ATRA has teratogenic potential if taken during therapy with ATRA and one months after end of treatment. Therefore an effective contraception is necessary to prevent teratology. Pregnancy tests will performed at screening and every 28 days. Only female are eligible to enter and participate in this study if she is of a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, a bilateral oophorectomy (ovariectomy), a bilateral tubal ligation, or who is post-menopausal. Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value <40 pg/mL (<140 pmol/L). For most forms of HRT, at least 2 to 4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female subject is determined not to be post-menopausal, she must use adequate contraception, as defined immediately below. A female is also eligible to enter and participate in this study if she is of b) childbearing potential, including any female who has had a negative serum pregnancy test within one week prior to the first dose of study treatment, preferably as close to the first dose as possible and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are an intrauterine device with a documented failure rate of less than 1% per year, vasectomised partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female, complete abstinence from sexual intercourse for 14 days before exposure to study medication through the dosing period and for at least 28 days after the last dose of study medication, barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide),or oral contraceptives ((mini-pill is not a save contraception method and should be avoid). .
    Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 28 days following the last dose of study drug.
    A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide) or abstinence during the study.
    Patients who reject contraceptive methods are not allowed to take part in this study.
    9. Adequate organ function
    E.4Principal exclusion criteria
    1. Patients with more than 20.000/µl leukocytes in the peripheral blood that cannot be controlled by Hydroxyurea.
    2. Patients with a valid option for intensive chemotherapy and/ or stem cell transplantation. (Patients after allogeneic stem cell transplant must be off immunsuppressive agents for at least 2 weeks prior to study entry and Graft- versus host disease must have resolved to Grade <= 2)
    3. Patients with other available therapy options that are likely to induce remission or to prolong patients´ lives.
    4. Acute promyelocytic leukemia (APL)
    5. History of cancer that according to the Investigator might confound the assessment of the endpoints of the study
    6. Uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
    7. Poorly controlled hypertension (defined as systolic blood pressure (SBP) of ≥140 mmHg). Note: Initiation or adjustment of antihypertensive medication is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/ DBP values from each BP asessment must be <140/90 mmHg in order for a subject to be eligible for he study.
    8. Prolongation of corrected QT interval (QTc) > 480 ms
    9. History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction (MI), unstable angina, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
    10. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
    11. History of cerebrovascular infarction or bleeding, pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti- coagulant agents for at least 6 weeks are eligible
    12. Evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to AML- related thrombocytopenia which will be treated using platelet transfusions). Also, patients with known endobronchial lesions and/ or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
    13. Prior major surgery or trauma within 28 days prior to first dose of study drug
    14. Treatment with an investigational agent within 21 days or 5 half-lifes, whichever is longer prior to the first dose of study drug.
    15. Concurrent cytoreductive chemotherapy except hydroxyurea.
    16. Known immediate or delayed hypertensitivity reaction or idiosyncrasy to Tretinoin, Retinoide, vitamin A, soya, peanuts or Tranylcypromine.
    17. Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
    18. Patients with known epilepsy or patients with known psychiatric affections (bipolar disorder, schizophrenia, suicidal patients)
    19. Pregnant or lactating and actively breastfeeding patients. Patients unwilling to use effective contraception methods (s. 5.2.1; 8.) cannot take part in this study.
    20. Patients who are indignant to comply with nutritional conditions (see Protocol)
    21. Poorly adjusted diabetes mellitus
    22. Patients with hereditary Galaktose-Intolerance, Lactase-Intolerance or Glucose-Galactose-Malabsorption, Fructose- Intolerance
    23. Known drug or alcohol abuse
    24. Phaeochromocytoma or carcinoid tumor
    25. Known cerebral vascular disease or other malformation of vessels (e.g. aneurysma)
    26. Diabetes insipidus
    27. hyperthyreodism or other diseases with risk for hypertensive crisis
    28. Patients taking any of the following prohibited medication due to interaction with a) tretinoin and b) TCP.
    a) Tretinoin Vitamine A,
    Tetracycline,
    Medication inducing P450 enzymes: rifampicine, glucocorticoid, Phenobarbital
    Medication inhibiting P450 enzymes: Ketoconazol, erythromycine, azole, cimetidine, verapamil, diltiazem, ciclosporine, all-trans-retinoic acid
    Antifibrinolytics (Tranexamacid, Aminocapronacid or Aprotinin)
    b) TCP Concurrent medication with serotonin reuptake inhibitors SSRI is prohibited regarding the risk of serotonin syndrome (10 days up to after TCP treatment):
    • Fluoxetin
    • Paroxetin
    • Fluvoxamin
    • Clomipramin
    • Venlafaxin

    Concurrent medication with other serotoninerg is prohibited (risk of hypertensive crisis and serotonin syndrome):
    • Sumatriptane and other triptanes
    • Buspirone
    • Imipramine
    • Amphetamine
    • Indirect Sympathomimetc drugs drugs

    Further concurrent drugs are prohibited:
    • L-Tryptophane (risk of delirium)
    • Disulfiram (unknown interaction)
    • Pethidine, Tramadol, Dextromorphane (risk of circulatory and respiratory instability)
    • ether
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of the cumulative response rate (CR, CRp, CRi, PR) of all AML patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after each cycle, each cycle consists of 28 days
    E.5.2Secondary end point(s)
    • To assess the safety and tolerability of repeated oral administration of Tretinoin and Tranylcypromin to patients with AML.
    • To assess the cumulative incidence and degree of histone methylation of promotor genes in AML blasts after treatment with Tretinoin and tranylcylpromine, and correlation with clinical reponse.
    • To compare in vivo treatment effects onto histone methylation levels and differentiation with TCP/ATRA effects in AML blasts exposed in vitro.
    • To assess overall survival (OS) in relationship to historical control patients
    • To determine the duration of response
    • Identification of molecular biomarkers that determine response to TCP/ATRA
    E.5.2.1Timepoint(s) of evaluation of this end point
    after each cycle, each cycle consists of 28 days
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    first administration of tranylcypromine in AML
    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.8.3 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 concerned4
    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
    end of the trial is defindes as the time point the data bank is locked.
    Justification for this definition: study- specific documentation has to be completed until this time- point.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state16
    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)
    not different from the expected normal treatment of that condition
    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 Decision2014-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-29
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