Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   43209   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    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) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004246-20
    Sponsor's Protocol Code Number:20810
    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:2018-02-07
    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 number2017-004246-20
    A.3Full title of the trial
    A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers

    Formerly: A Phase 1/2 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers
    A.4.1Sponsor's protocol code number20810
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03215511
    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 SponsorBayer Consumer Care AG
    B.1.3.4CountrySwitzerland
    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 supportBayer Consumer Care AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSelitrectinib
    D.3.2Product code BAY 2731954
    D.3.4Pharmaceutical form Capsule, hard
    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 INNnot available
    D.3.9.1CAS number 2097002-61-2
    D.3.9.2Current sponsor codeBAY 2731954
    D.3.9.3Other descriptive nameSelitrectinib
    D.3.9.4EV Substance CodeSUB189790
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSelitrectinib
    D.3.2Product code BAY 2731954
    D.3.4Pharmaceutical form Capsule, hard
    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 INNnot available
    D.3.9.1CAS number 2097002-61-2
    D.3.9.2Current sponsor codeBAY 2731954
    D.3.9.3Other descriptive nameSelitrectinib
    D.3.9.4EV Substance CodeSUB189790
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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 nameSelitrectinib
    D.3.2Product code BAY 2731954
    D.3.4Pharmaceutical form Powder and solvent for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNnot available
    D.3.9.1CAS number 2097002-61-2
    D.3.9.2Current sponsor codeBAY 2731954
    D.3.9.3Other descriptive nameSelitrectinib
    D.3.9.4EV Substance CodeSUB189790
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    NTRK fusion cancers previously treated with a TRK inhibitor
    E.1.1.1Medical condition in easily understood language
    Solid tumors of all type, including primary CNS tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10049516
    E.1.2Term Malignant tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10007958
    E.1.2Term Central nervous system neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the recommended dose for further study of oral selitrectinib in 2 patient groups with previously treated neurotrophic tyrosine receptor kinase (NTRK) fusion cancers defined as age 12 years and older and age < 12 years.
    E.2.2Secondary objectives of the trial
    • To characterize the pharmacokinetic (PK) properties of selitrectinib
    • To characterize the safety and tolerability of selitrectinib.
    • To assess objective response rate (ORR) according to best response by
    Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    as determined by Investigator.
    • To assess ORR according to best response by Response Assessment in
    Neuro Oncology (RANO), as determined by Investigator, in patients with
    primary central nervous system (CNS) malignancies with NTRK fusion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand and the willingness to sign a written informed
    consent. A signed informed consent must be obtained prior to any studyspecific
    procedures. Parent/guardian of child or adolescent subjects has
    the ability to understand, agree to, and sign the study Informed Consent
    Form and applicable Pediatric Assent Form before initiation of any
    protocol related procedures; subject has the ability to give assent, as
    applicable, at the time of parental/guardian consent.
    2. Advanced solid tumor for which, in the opinion of the Investigator, no
    other standard therapy offers greater benefit.
    3. A solid tumor diagnosis in the setting of:
    a. a documented NTRK fusion and a clinical history of relapse following a
    response to a prior TRK inhibitor
    b. a documented NTRK fusion unresponsive to a prior TRK inhibitor
    c. a documented NTRK fusion and a clinical history of intolerance to a
    prior TRK inhibitor
    A list of agents with known TRK inhibitor activity is provided in Appendix
    A. Other agents not listed may also be considered upon Sponsor review.
    NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified in a
    CLIA-certified (or equivalently-accredited diagnostic) laboratory. If such
    a report cannot be provided, other available certifications/accreditations
    are required and need to be documented. Acceptable methods of
    detection of NTRK fusion include next-generation sequencing (NGS),
    fluorescence in situ hybridization (FISH), real-time polymerase chain
    reaction (RT-PCR) with the following documented in a written report:
    • For NGS, the report indicates that a fusion was detected between an
    NTRK gene (NTRK1, NTRK2, or NTRK3) and a specific partner gene.
    • For FISH, the report indicates that a probe mapping to an NTRK gene
    (NTRK1, NTRK2, or NTRK3) and/or a probe mapping to a specific partner
    gene were found to be colocalized by microscopy.
    • For RT-PCR, the report indicates that a pair of primers targeting an
    NTRK gene (NTRK1, NTRK2, or NTRK3) on one end and a specific partner
    gene on the other end amplified a detectable target.
    If enrolling a patient based on the pan-TRK IHC result, documentation of
    NTRK fusion must be provided using NGS. If enrolling a patient based on
    FISH result, additional documentation of NTRK fusion using NGS is
    preferred.
    Exception: Patients with infantile fibrosarcoma (IFS) or congenital
    mesoblastic nephroma (CMN) may be enrolled based on confirmation of
    an ETV6 aberration without an identified partner gene (for example,
    patients may have been diagnosed with IFS or CMN based on an ETV6+
    FISH test without identifying [or testing] for NTRK3).
    4. Performance Status: Eastern Cooperative Oncology Group (ECOG)
    score ≤ 2 (in adults), Karnofsky Performance Status (KPS) ≥ 50% (age
    ≥ 16 years) or Lansky Performance Score (LPS) ≥ 50% (age < 16
    years).
    5. Evaluable and/or measurable disease by RECIST v1.1, RANO or
    International Neuroblastoma Response Criteria (INRC).
    6. Life expectancy of at least 3 months.
    7. At least 1 month of age.
    8. Tissue submission. Samples from 2 time points are required if
    available.
    a. Tumor sample obtained after patient progression on therapy with last
    kinase inhibitor with anti TRK activity prior to consenting for this trial. A
    fresh biopsy in this setting is preferred if it can be safely obtained or this
    may be an archived sample. See Section 7.5.4 for specifics.
    b. Archived tumor tissue sample obtained prior to when patient started
    on the first anti-TRK therapy.
    If the site has tissue from both time points, but will only provide tissue
    from 1 time point, the sample obtained post-progression on the last anti-
    TRK therapy is preferred. If no tumor tissue samples from either time
    point are available, the patient may still be eligible with Sponsor
    approval.
    9. Adequate hematologic function, for patients without known or
    suspected bone marrow involvement, defined as in Section 4.1
    10. Adequate hepatic function defined as:
    a. Aspartate aminotransferase (AST) and alanine aminotransferase
    (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN if in the setting
    of liver metastases
    b. Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN if in the setting of liver
    metastases or Gilbert's disease; patients with higher total bilirubin levels
    due to Gilbert's disease or hepatic metastases may be enrolled with
    Sponsor approval
    E.4Principal exclusion criteria
    1. Prior exposure to second generation TRK inhibitor (e.g. selitrectinib,
    repotrectinib (TPX-0005), taletrectinib (DS-6501b/AB-106)). Exception
    is in case patient presented intolerance to the second generation TRK
    inhibitor agent and the duration of exposure was less than 28 days. No
    previous treatment with selitrectinib is allowed.
    2. If received recent therapy, evidence of moderate-severe/uncontrolled
    toxicities that in the opinion of the investigator are limiting of
    subsequent therapy or unstable organ dysfunction due to previous
    treatment.
    3. Concurrent treatment with a strong CYP3A4 inhibitor or inducer (refer
    to Appendix B), consumption of grapefruit juice or Seville orange, or
    drugs associated with QT prolongation. The Investigator should review
    concomitant medications with their site pharmacist as the list can
    change frequently.
    4. Clinically significant active cardiovascular disease or history of
    myocardial infarction within 3 months prior to planned start of
    selitrectinib, cardiomyopathy; current or known history within the past 6
    months of prolonged QT interval corrected for heart rate (QTc interval) >
    480 milliseconds. If there is a known explanation for a limited period of
    a prolonged QT interval (i.e., a medication known to cause prolonged QT
    interval was administered and has since been discontinued with clearly
    documented normal QT interval thereafter), that subject may be
    enrolled. If subject suffers from congestive heart failure, with onset
    more than 3 months prior to planned start of selitrectinib, then New York
    Heart Association (NYHA) classification should be functional capacity I
    at maximum (APPENDIX J).
    5. Major surgery within 7 days of enrollment. Catheter placement,
    endoscopic procedures, and dental surgery are not considered major
    surgery.
    6. Uncontrolled systemic bacterial, fungal or viral infection. Infections
    treated with a stable dose of antimicrobial therapy for at least 7 days are
    allowed. Prophylactic antibiotics are allowed.
    7. Pregnancy or lactation.
    8. Known hypersensitivity to any of the components of the
    investigational agent, selitrectinib or Ora Sweet® SF and OraPlus®, for
    patients who will take the selitrectinib suspension. Please refer to
    Appendix G for the complete list of ingredients for Ora-Sweet® SF and
    Ora-Plus®.
    9. Known history of human immunodeficiency virus (HIV). Refer to
    Section 4.2 Exclusion Criteria of the protocol for additional details.
    10. Hepatitis B (HBV) or C (HCV) infection. Refer to Section 4.2 Exclusion
    Criteria of the protocol for additional details.
    11. Any malabsorption condition.
    12. Substance abuse, medical, psychological, or social conditions that
    may interfere with the patient's participation in the study or evaluation
    of the study results.
    E.5 End points
    E.5.1Primary end point(s)
    MTD and/or recommended dose for further study of selitrectinib in
    patients age 12 years and older and age < 12 years.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every cohort from baseline until disease progression, unacceptable
    toxicity, patient's withdrawal of consent, or death.
    E.5.2Secondary end point(s)
    • Incidence, severity, and duration of AEs, including all, serious, and
    those considered treatment related.
    • Changes from baseline in clinical safety laboratory values and vital
    signs.
    • ORR as determined by the Investigator, in patients with a documented
    NTRK fusion cancer previously treated with a TRK inhibitor using RECIST
    v1.1 for solid tumors.
    • ORR as determined by the treating Investigator using RANO in patients
    with primary CNS malignancies,.
    • To characterize the PK properties of selitrectinib (Cmax, AUC(0-10),
    AUC(0-12) for BID dosing, and AUC(0-24) for QD dosing, if applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK properties of selitrectinib will be determined between C1D6 and C1D8
    EORTC QLQ-C30 and EQ-5D or PedsQL should be conducted at the same
    cycle visits as the disease assessment.
    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 Yes
    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
    Dose escalation
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Hong Kong
    Ireland
    Italy
    Korea, Republic of
    Singapore
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors until their legal majority age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 186
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA