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    Summary
    EudraCT Number:2017-004246-20
    Sponsor's Protocol Code Number:20810
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-01-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-004246-20
    A.3Full title of the trial
    Bayer 20810 - 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 1/2 study of the investigational treatment Selitrectinib in adults and minors that have a previously treated cancer with a change in a gene called NTRK.
    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 AddressMüllerstraße 178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 30300139003
    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 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
    Phase 1:
    To determine the recommended dose for further study of oral Selitrectinib in 2 patient groups defined as age 12 years and older and age < 12 years with previously treated neurotrophic tyrosine kinase (NTRK) fusion cancers.
    Phase 2:
    To assess objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by an independent radiology review (IRR) in documented NTRK fusion cancer patients previously treated with a TRK inhibitor who have progressed.
    E.2.2Secondary objectives of the trial
    Phase 1:
    -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 RECIST v1.1 as determined by Investigator, in patients with a documented NTRK fusion cancer previously treated with a tropomyosin receptor kinase (TRK) inhibitor.
    -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.

    Phase 2:
    -To characterize the safety and tolerability of selitrectinib at the recommended Phase 2 dose (RP2D) in patients age 12 years and older and patients age < 12 years.
    -To assess ORR determined by RECIST v1.1, as determined by an IRR in patients with NTRK fusion cancers who have discontinued prior TRK therapy due to intolerance and/or nonresponse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Ability to understand and willingness to sign a written informed consent form (ICF). Signed ICF must be obtained prior to any study-specific procedures. Parent/guardian of child or adolescent subjects has the ability to understand, agree to, and sign the study ICF and applicable paediatric 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.documented NTRK fusion and clinical history of relapse following a response to a prior TRK inhibitor
    b.documented NTRK fusion unresponsive to prior TRK inhibitor
    c.documented NTRK fusion and clinical history of intolerance to prior TRK inhibitor 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.
    4.ECOG score ≤ 2 in adults or KPS Score ≥ 50% (age ≥16 years ) or LPS ≥ 50% (age < 16yers)
    5.Evaluable and/or measurable disease by RECIST v1.1, RANO or INRC.
    6.Life expectancy of at least 3 months.
    7.At least 1 mth of age.
    8.Tissue submission. Samples from 2 time points required if available
    9.Adequate hematologic function, for patients without known or suspected bone marrow involvement, defined as:
    a. Hemoglobin (Hb) ≥ 8.0 g/dL
    b. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L
    c. Platelets (Plt) ≥ 100 × 109 /L without need for regular transfusion support
    Patients with known or suspected bone marrow involvement will not be evaluable for hematologic DLT and can enroll with:
    a.Hb ≥8.0 g/dL (transfusions allowed)
    b.ANC ≥0.75 × 109 /L
    c.Plt ≥50 × 109 /L (transfusions allowed)
    10.Adequate hepatic function defined as:
    a.AST and 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
    11. Patients must have adequate blood clotting, as assessed by the following laboratory requirements to be conducted within 14 days before the first dose of study drug:
    - International normalized ration (INR) ≤1.5 X ULN
    - Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤1.5 X ULN
    -Patients on chronic anticoagulation therapy, including direct-acting oral anticoagulants, will be allowed to participate if there is no sign of active bleeding and PT/INR and aPTT or PTT test results are, at the investigator’s discretion, compatible with acceptable benefit-risk ratio
    12.For patients age 18 yrs and older: Adequate renal function defined as serum creatinine ≤2.0 mg/dL or estimated glomerular filtration ≥30 mL/min using CKD-EPI equation. For patients between 1-18 years old: Estimated glomerular filtration rate≥30mL/minute/1.73 m2
    based on the modified Schwartz formula.For patients <1 year old, the serum creatinine should be less than 97.5th percentile (approximately 2 standard deviations).
    13.At least 5 half-lives since most recent larotrectinib or entrectinib dose. At least 5 halflives OR at least 7 days (whichever is longer) since last dose of other tyrosine kinase inhibitor. In case the most recent anticancer therapy was chemotherapy, immunotherapy, monoclonal antibody, other non kinase inhibitors or other anticancer treatment types, then the wash-out period should be 5 half-lives OR at least 21 days since last systemic anticancer therapy (whichever is shorter).
    14. Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of selitrectinib and there has been no change in steroid dose, if taking steroids to manage CNS symptoms, for 7 days prior to the first dose of selitrectinib. The patient can be receiving any dose of steroids as long as dosing meets specifications noted above.
    15. Negative serum pregnancy test prior to C1D1 study drug if a woman of child-bearing potential. Pregnancy tests are not required for pre-pubertal (Tanner 1) girls, surgically sterilized women or post-menopausal women.
    16. Agreement to adequate contraception in male and female patients with reproductive potential for the duration of treatment and for 3 mths following study completion.
    17. Ability to swallow capsules or liquid suspension orally or receive liquid enterally via a naso- or gastro-feeding tube, and comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
    E.4Principal exclusion criteria
    1.Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib (TPX0005), 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, 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 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 NYHA should be functional capacity I at maximum.
    5. Major surgery within 7 days of enrollment. Catheter placement, endoscopic procedures, and dental surgery are not considred 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 receive Selitrectinib suspension.
    9. Known history of human immunodeficiency virus (HIV) infection. If previous test was collected more than 3 months prior to the first dose of study drug, then a new test must be performed up to 28 days prior to the study drug start using a blood test for HIV according to local regulations.
    10. Hepatitis B (HBV) or C (HCV) infection. If previous test was collected more than 3 months prior to the first dose of study drug, then a new test must be performed screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel.
    a. Patients positive for hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy.
    b. Patients positive for anti-HCV antibody will be eligible if they are negative for HCVRNA.
    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)
    Phase 1:
    Identification of MTD and/or recommended dose for further study of Selitrectinib in patients age 12 years and older and age < 12 years.
    Phase 2:
    ORR as determined by IRR using RECIST v1.1 in patients age 12 years and older and age < 12 years with documented NTRK fusion cancers and demonstration of progression following (or during receipt of) previous treatment with a TRK inhibitor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1:
    Every cohort from baseline until disease progression,unacceptable toxicity, patient's withdrawal of consent, or death.
    Phase 2:
    Approximately every 8 weeks for the first 12 cycles, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed.
    E.5.2Secondary end point(s)
    Phase 1:
    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 1.1 for solid tumors.
    ORR as determined by the treating Investigator using RANO in patients with primary CNS malignancies.
    Overall survival (OS) defined as the number of months from the initiation of Selitrectinib to the date of death due to any cause.
    To characterize the PK properties of Selitrectinib (Cmax, AUC(0-10), AUC(0-12) and AUC(0-24), if applicable..
    Phase 2:
    Incidence, severity, and duration of AEs, including all, serious, and those considered treatment related in patients age 12 years and older and age < 12 years
    Changes from baseline in clinical safety laboratory values and vital signs.
    ORR using RECIST v1.1 as determined by IRRin Cohort 2
    ORR using RECIST v1.1 or RANO criteria as appropriate by Investigator in Cohort 1 and Cohort 2
    Duration or response (DOR) will be determined for patients with best overall response of confirmed CR or PR by 1) an IRRand 2) the treating Investigator; DOR is defined as the number of months from the start of CR or PR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease is documented, or death.
    Progression-free survival (PFS) as determined by IRRand Investigator.
    Overall survival (OS) Clinical benefit rate (CBR) as determined by IRR and Investigator.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1:
    PK properties of Selitrectinib will be determined between C1D6 and C1D8

    Phase 1 and Phase 2: 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 months8
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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.1.1Number of subjects for this age range: 36
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    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 Decision2019-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-10
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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