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    Summary
    EudraCT Number:2017-000206-38
    Sponsor's Protocol Code Number:54767414MMY3012
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-17
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-000206-38
    A.3Full title of the trial
    A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous
    Administration of Daratumumab in Subjects With Relapsed or Refractory
    Multiple Myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to compare the effectiveness and pharmacokinetics (the way the body absorbs, distributes, and gets rid of a drug) of Daratumumab given through the subcutaneous route versus the intravenous route in patients with relapsed or refractory multiple myeloma (blood cancer in the bone marrow)
    A.4.1Sponsor's protocol code number54767414MMY3012
    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 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 Yes
    D.2.1.1.1Trade name DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    D.3.2Product code HuMax-CD38
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 (Daratumumab)
    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 number20
    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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal antibody
    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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab co-formulated with recombinant human hyaluronidase PH20
    D.3.2Product code JnJ 54767414
    D.3.4Pharmaceutical form 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
    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 µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Multiple myeloma
    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
    The main objective of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara-CF) is non-inferior to intravenous (IV) administration of daratumumab (Dara- IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
    E.2.2Secondary objectives of the trial
    - To assess the pharmacokinetics and immunogenicity of Dara-CF and
    Dara-IV
    - To evaluate the safety of Dara-CF and Dara-IV
    - To evaluate the clinical benefit of Dara-CF and Dara-IV
    - To evaluate the immunogenicity of rHuPH20 following Dara-CF
    administration
    - To evaluate patient-reported satisfaction with Dara-CF and Dara-IV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with at least 18 years of age
    2. Subjects who documented with multiple myeloma as defined by the criteria below:
    a)Multiple myeloma diagnosis according to the IMWG diagnostic criteria
    b)Measurable disease at Screening as defined by any of the following:
    i) Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    ii) Light chain multiple myeloma without measurable disease in the serum or the urine:
    Serum immunoglobulin FLC ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
    3. Evidence of a response (partial response [PR] or better based on investigator’s determination of response by IMWG criteria) to at least 1 prior treatment regimen.
    4. Relapsed or refractory disease as defined below:
    a) Relapsed disease is defined as an initial response to previous treatment, followed by confirmed PD by IMWG criteria greater than (>) 60 days after cessation of treatment.
    b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or > 60 days after cessation of treatment.
    5. Received at least 3 prior lines of therapy including a PI (>= 2 cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). 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 4 days) would not be considered prior lines of therapy
    OR
    Refractory to both a PI and an IMiD. For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one.
    6. Eastern cooperative oncology group (ECOG) performance Status score of 0, 1, or 2
    7. Subjects who has pretreatment clinical laboratory values meeting the following criteria during the screening phase:
    a) Hemoglobin >= 7.5 gram per decilitre (g/dL) (>= 5 millimoles per litre [mmol/L])
    b) Absolute neutrophil count >= 1.0 × 10^9/Litre (L)
    c) Platelet count >= 50 × 10^9/L
    d) Aspartate aminotransferase (AST) <= 2.5 × upper limit of normal (ULN)
    e) Alanine aminotransferase (ALT) <= 2.5 × ULN
    f) Total bilirubin <= 2.0 × ULN; except in subjects with congenital bilirubinemia, such as Gilbert syndrome
    g) Estimated creatinine clearance > 20 milliletre per minute (mL/min) per 1.73m^2
    h) Albumin-corrected serum calcium <=14 mg/dL (<= 3.5 mmol/L) or free ionized calcium <= 6.5 mg/dL (<=1.6 mmol/L).
    8. Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to
    dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy.
    9. Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization.
    10. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
    E.4Principal exclusion criteria
    1 Subjects who received daratumumab or other anti-CD38 therapies previously
    2.Subjects who received anti-myeloma treatment within 2weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days)before treatment
    3.Subjects who received autologous stem cell transplant within 12weeks before the date of randomization,or the subject has previously received allogeneic stem cell transplant (regardless of timing)
    4.Subjects who has plans to undergo a stem cell transplant prior to progression of disease on this study
    5.History of malignancy (other than multiple myeloma)if all treatment of that malignancy was completed at least 2years before consent and the patient has no evidence of disease(exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix,or breast,or other non-invasive lesion,that in the opinion of the investigator,with concurrence with the sponsor's medical monitor,is considered cured with minimal risk of recurrence within 3years)
    6.Subjects with clinical signs of meningeal involvement of multiple myeloma
    7.Subjects with either of the following:
    a)Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) is <50% of predicted normal
    b)Known moderate or severe persistent asthma,or a history of asthma within the last 2 years,or currently has uncontrolled asthma of any classification (Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.)
    8.Subjects with any of the following:
    a)Known to be seropositive for human immunodeficiency virus (HIV)
    b)Known to be hepatitis B(hepatitis B surface antigen[HBsAg]positive,or antibodies to hepatitis B surface or core antigens[antiHBs or antiHBc]with hepatitis B virus [HBV]-DNA quantitation positive).Subjects who are positive for antiHBs or antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result at screening. Those who are PCR positive will be excluded
    c)Known to be seropositive for hepatitis C
    9.Subjects with concurrent medical or psychiatric condition or disease (example,active systemic infection,uncontrolled diabetes, acute diffuse infiltrative pulmonary disease)that is likely to interfere with study procedures or results,or that in the opinion of the investigator would constitute a hazard for participating in this study
    10.Subjects with clinically significant cardiac disease,including:
    a) Myocardial infarction within 6months before date of randomization,or unstable or uncontrolled disease/condition related to or affecting cardiac function(eg unstable angina,congestive heart failure, New York Heart Association Class III-IV)
    b)Uncontrolled cardiac arrhythmia(Grade 2 or higher)or clinically significant electrocardiogram (ECG) abnormalities
    c) Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula >470 msec
    11.Subjects with known allergies,hypersensitivity,or intolerance to any of the study drugs,hyaluronidase,mAbs,human proteins,or their excipients,or known sensitivity to mammalian-derived products
    12.Subjects with plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential)or Waldenström's macroglobulinemia or POEMS syndrome(polyneuropathy,organomegaly,endocrinopathy,M-protein, nd skin changes) or amyloidosis.
    13.Subjects with known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder) 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 (eg, compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    14.Subjects who are pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug.
    15.Subjects who has plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.
    16.Subjects who received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study drug (except for investigational anti-myeloma treatments, which cannot be taken within 2 weeks
    before Cycle 1 Day 1)
    17.Subjects with major surgery within 2weeks before randomization, or has not fully recovered from an earlier surgery, or has major 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. Kyphoplasty or vertebroplasty are not considered major surgery
    18.Subjects with plasmapheresis within 28 days before randomization
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall response rate (ORR), defined as the number and proportion of subjects with a partial response (PR) or better according to the international myeloma working group (IMWG) response criteria
    2. Maximum Ctrough, defined as the serum predose concentration of daratumumab on Cycle 3 Day 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 6 months after the last subject has been randomized
    2. Cycle 3 Day 1
    E.5.2Secondary end point(s)
    1. Rate of infusion-related reaction (IRRs)
    2. Progression-free survival (PFS), defined as the time from randomization to the date of disease progression or death due to any cause, whichever occurs first
    3. Rate of very good partial response (VGPR) or better, according to the IMWG response criteria
    4. Rate of complete response (CR) or better, according to the IMWG response criteria
    5. Time to next therapy, defined as the time from randomization to the start of the first subsequent anti-cancer therapy
    6. Overall survival (OS), defined as the time from randomization to the date of death
    7. Patient-reported satisfaction with therapy, defined as the mean of responses to 7 of 9 questions in the modified Cancer Therapy Satisfaction Questionnaire (modified-CTSQ)
    8. Duration of response, defined as date of onset of first response until date of disease progression or death
    9. Time to response, defined as the time from randomization until onset of first response
    E.5.2.1Timepoint(s) of evaluation of this end point
    There is no interim analysis planned for the primary or secondary endpoints. Both sets of endpoints will be analyzed 6 months after the last subject has been randomized.
    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 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
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Multicenter
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Australia
    Brazil
    Canada
    China
    Czech Republic
    France
    Greece
    Israel
    Italy
    Japan
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    Ukraine
    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 study is considered completed approximately 18 months after the last subject is randomized. Data collected through the end of the study will be reported as an addendum to the Clinical Study Report. The sponsor will ensure that subjects benefiting from study treatment can continue to receive treatment after the end of 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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 480
    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)
    it is specified in the protocol
    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 Decision2017-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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