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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-004203-41
    Sponsor's Protocol Code Number:54767414MMY2040
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-02
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2017-004203-41
    A.3Full title of the trial
    A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination with Standard Multiple Myeloma Treatment Regimens
    Multicentrické klinické hodnocení fáze 2 hodnotící subkutánní podání daratumumabu v kombinaci se standardními režimy léčby mnohočetného myelomu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the safety, effectiveness and pharmacokinetics of Daratumumab given through the subcutaneous route in combination with standard bone marrow cancer treatment regimens
    A.4.1Sponsor's protocol code number54767414MMY2040
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03412565
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
    D.3.2Product code JnJ-54767414
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJnJ-54767414
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant human hyaluronidase PH20 (Vorhyaluronidase Alfa)
    D.3.9.1CAS number 757971-58-7
    D.3.9.2Current sponsor coderHuPH20 (Gen1, HZ201, HUA) or (Gen2, HZ202, HUB) PH20
    D.3.9.3Other descriptive namePEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
    D.3.9.4EV Substance CodeSUB180813
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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 Yes
    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
    Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Bone marrow cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in subjects with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
    E.2.2Secondary objectives of the trial
    - To evaluate safety and pharmacokinetics (PK) of SC administration of daratumumab in combination with standard MM regimens
    - To evaluate additional clinical benefit of SC daratumumab administered in combination with standard MM regimens in subjects with MM
    - To characterize the immunogenicity of daratumumab and rHuPH20 following SC administration
    - To evaluate minimal residual disease (MRD) negativity rate in the D-VMP (daratumumab SC in combination with bortezomib, melphalan, and prednisone), D-Kd (daratumumab SC in combination with carfilzomib and dexamethasone), and D-Rd (daratumumab SC in combination with lenalidomide and dexamethasone) cohorts.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.>18 years of age (or the legal age of consent if it is higher than 18 years of age in the jurisdiction in which the study is taking place)
    2.MM diagnosed according to the IMWG diagnostic criteria
    3.Measurable,secretory disease as defined by any of the following:
    -Serum M-protein level ≥1.0 g/dL;or
    -Urine M-protein level ≥200 mg/24 hours; or
    -Light chain MM, for subjects without measurable disease in the serum or urine: serum Ig free light chain (FLC) ≥10 mg/dL and abnormal FLC ratio
    4.a.For inclusion into the D-VRd cohort for newly diagnosed disease: - Newly diagnosed MM by IMWG criteria and eligible/planned for high dose therapy and ASCT
    4.b.For inclusion into the D-VMP cohort: - Newly diagnosed and previously untreated MM by IMWG criteria and not considered a candidate for high-dose chemotherapy with ASCT due to:Being age ≥65years, or in subjects <65 years: presence of important comorbid condition(s) will make stem cell transplant intolerable for the subject
    4.c.For inclusion into the D-Rd cohort for relapsed or refractory disease: •Subject must have received at least 1 prior line of therapy for MM•Subjects must have progressed from or be refractory to their last line of treatment•Subject must have achieved a response (PR or better based on investigator’s evaluation of response by the IMWG criteria) to at least 1 prior treatment regimen
    4.d. For inclusion in the D-Kd cohort for relapsed or refractory disease:
    -Subject must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
    -A single line of therapy may consist of 1 or more agents,and may include induction,hematopoietic stem cell transplantation, and maintenance therapy.Radiotherapy, bisphosphonate,or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 mg/day for 4days)would not be considered prior lines of therapy.
    -Subject must have achieved a response (PR or better based on investigator’s evaluation of response by the IMWG criteria) to the first treatment regimen
    -Subject must have progressed from or be refractory to the first line of treatment. •Relapsed disease is defined as progression of disease after an initial response to previous treatment, more than 60 days after cessation of treatment •Refractory disease is defined as confirmed PD by IMWG criteria during previous treatment or ≤60 days after cessation of treatment
    5.ECOG Performance Status grade of 0,1,or2
    6.Pre-treatment clinical laboratory values during the Screening Phase(all cohorts):
    a.hemoglobin ≥7.5g/dL (≥4.65mmol/L); D-Kd cohort 8.0 g/dL (without prior RBC transfusion within 7days before the laboratory test;recombinant human erythropoietin use is permitted)
    b.absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted)
    c. platelet count for D-Rd,D-Kd and D-VRd cohorts: >75×109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells;otherwise platelet count >50×109/L (transfusions are not permitted within 7days of testing to achieve this minimum platelet count);for the D-VMP cohort:platelet count ≥70x109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells;otherwise platelet count >50×109/L (transfusions are not permitted within 7 days of testing to achieve this minimum platelet count
    d.aspartate aminotransferase ≤2.5×ULN
    e.alanine aminotransferase ≤2.5×ULN
    f.For the D-Rd cohort: total bilirubin ≤2.0×ULN; except in subjects with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤2.0×ULN is required); for the, D-Kd, D-VMP, and D-VRd cohorts: total bilirubin ≤1.5×ULN; except in subjects with congenital bilirubinemia,such as Gilbert syndrome (in which case direct bilirubin ≤1.5 × ULN is required);
    g. estimated creatinine clearance ≥40 mL/min(D-VMP cohort) or ≥30 mL/min (for D-VRd and D-Rd cohorts);or ≥20mL/min (D-Kd cohort)
    h.corrected serum calcium ≤13.5 mg/dL(≤3.4 mmol/L)or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
    7.1 D-VRd and D-Rd cohorts: A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at screening, the first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing
    D-VMP and D-Kd cohorts: A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days prior to dosing
    8.Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse, or to use one highly effective form of contraception and one additional effective contraceptive.Male subjects of reproductive potential who are sexually active with females of reproductive potential must always use a latex or synthetic condom during the study and for 3 months after discontinuing study treatment

    For an overview of all inclusion criteria please see Protocol
    E.4Principal exclusion criteria
    1.Prior or concurrent exposure to any of the following:
    -Daratumumab or other anti-CD38 therapies
    -Approved or investigational treatments for MM within 2 weeks of Cycle 1 Day 1
    -Maximum of 40 mg dexamethasone daily for a maximum of 4 days up to 21 days prior to the 1st dose
    -Investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives before Cycle 1 Day 1, or is currently enrolled in another investigational study
    -ASCT within 12 weeks before the date of administration of study treatment, or allogeneic stem cell transplant (regardless of timing) for the D-Rd and D-Kd cohorts
    -For D-Rd cohort, only: Refractory to lenalidomide, or who are intolerant to lenalidomide while on lenalidomide treatment are not eligible for the lenalidomide-containing cohorts
    -For D-Kd cohort, only: Subject has previously received carfilzomib
    2.History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease.
    3.Exhibits clinical signs of meningeal involvement of MM.
    4.Either of the following:
    -Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is <50% of predicted normal.
    -Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification
    For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension.
    5.Any of the following:
    -Known to be seropositive for human immunodeficiency virus;
    -Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or
    antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using realtime polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects
    with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
    6.Known to be seropositive for hepatitis C (anti-HCV antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
    7.Concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
    8.Clinically significant cardiac disease, including:
    -myocardial infarction within 6 months before Cycle 1 Day 1, or an unstable or uncontrolled disease/condition related to or affecting cardiac;
    -uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities; or screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTc) >470 msec.
    For D-Kd cohort only:
    -Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%
    -Uncontrolled hypertension, defined as an average systolic blood pressure >159 mmHg or diastolic >99 mmHg despite optimal treatment
    9. Allergies,hypersensitivity, or intolerance to any of the study drugs,hylauronidase, monoclonal antibodies,human proteins, or their excipients or known sensitivity to mammalian-derived products.
    For D-Kd cohort only: allergy, hypersensitivity, or intolerance to Captisol
    10.Plasma cell leukemia, Waldenström’s macroglobulinemia, POEMS syndrome, or amyloidosis
    11.Unable to comply with the study or the subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol specified assessments
    12.Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug
    13.Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
    14.Major surgery within 2 weeks before administration of study treatment, or has not fully recovered from surgery,or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration
    15.Plasmapheresis within 28 days before Cycle 1 Day 1
    16.For D-VRd and D-VMP cohorts: Received a strong CYP3A4 inducer within 5 half-lives prior to randomization.For D-VMP arm: neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI CTCAE Version 4.03.
    17.For D-VMP cohort: Neuropathy or neuropathic pain Grade 2 or higher, as defined by NCI CTCAE Version 4.03.
    For D-Kd cohort: Neuropathy or neuropathic pain Grade 3 or higher, as defined by NCI CTCAE Version 4.03
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall Response Rate (ORR), defined as the proportion of subjects with a partial response or better as defined by the International Myeloma Working Group (IMWG) response criteria (for D-VMP, D-Kd and D-Rd cohorts)
    2. Very Good Partial Response (VGPR) or better rate, defined as the proportion of subjects with a VGPR or better rate as defined by the IMWG response criteria (for D-VRd cohort)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At the end of each treatment cycle in D-VMP, D-Kd and D-Rd cohorts
    2. At the end of each treatment cycle in D-VRd cohort
    E.5.2Secondary end point(s)
    1. Serum concentrations of daratumumab
    2. Rate of Infusion-related Reaction (IRRs)
    3. VGPR or better rate as defined by the IMWG response criteria (for D-Kd, D-VMP and D-Rd cohort), and ORR as defined by the IMWG response criteria (for D-VRd cohort)
    4. Complete Response (CR) or better rate, as defined by the IMWG response criteria
    5. Duration of response (DOR), defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP and D-Rd cohorts, or VGPR or better for D-VRd cohort) to the date of first documented evidence of progressive disease or death due to progressive disease (PD)
    6. Incidence of anti-drug antibodies against daratumumab or rHuPH20
    7. Minimal residual disease (MRD) negativity rate in the D-Kd, D-VMP and D-Rd cohorts
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Predose on Day(D)1 of Cycle(C)1,C3,C4,postdose on D4 ofC1,C4(D-VRd cohort)Predose on D1 ofC1,C2,C3,C6,C9,postdose on D4 ofC1,C2(D-VMP)Predose on D1 ofC1,C3,C6,C9,C12,postdose on D4 ofC1,C3(D-Rd) &post-treatment visit at 30 Days (EOT)&at 8wks (FUP)after last dose of study drug in all cohorts
    2.Throughout study at the time of daratumumab administration in all cohorts
    3&4.At screening &when CR is suspected or maintained throughout treatment phase&30-days post-treatment
    5.At the date of first documented evidence of progressive disease(PD) or death due to PD
    6.Predose on D1 ofC1,C4(D-VRd)Predose on D1 ofC1,C3,C6,C9(D-VMP)Predose on D1 ofC1,C3,C6,C9,C12(D-Rd)&EOT&FUP
    7.At screening, at the time of suspected CR,&in patients who maintain CR, at 12,18,24months(M)&every 12M thereafter
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Biomarker analyses
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Brazil
    Czech Republic
    France
    Germany
    Israel
    Japan
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 study is considered completed approximately 18 months after the last subject is enrolled or when the sponsor decides to stop the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 180
    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)
    Patients who have completed participation in the trial will be eligible to receive further treatment off protocol as per local 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 Decision2018-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
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