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    Summary
    EudraCT Number:2020-002359-39
    Sponsor's Protocol Code Number:213406
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-09-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-002359-39
    A.3Full title of the trial
    A PHASE 1, MULTICENTRE, OPEN-LABEL, DOSE-ESCALATION AND COHORT EXPANSION STUDY OF NIRAPARIB AND DOSTARLIMAB IN PAEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMOURS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab
    in Paediatric Participants With Solid Tumours
    A.3.2Name or abbreviated title of the trial where available
    Storytime
    A.4.1Sponsor's protocol code number213406
    A.5.4Other Identifiers
    Name:Project IDNumber:52699
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/303/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park
    B.5.3.2Town/ cityWest Uxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448007839733
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameDostarlimab
    D.3.2Product code GSK4057190
    D.3.4Pharmaceutical form 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 INNDostarlimab
    D.3.9.1CAS number 2022215-59-2
    D.3.9.2Current sponsor codeGSK4057190
    D.3.9.3Other descriptive nameTSR-042, WBP-285, Anti-PD-1 (Programmed Cell Death Protein 1) mAb, IgG4
    D.3.9.4EV Substance CodeSUB195307
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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.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 nameNiraparib
    D.3.2Product code GSK3985771
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeGSK3985771
    D.3.9.3Other descriptive name niraparib tosylate monohydrate
    D.3.9.4EV Substance CodeSUB177208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Recurrent or refractory solid tumour
    E.1.1.1Medical condition in easily understood language
    cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Part 1A: to establish the recommended Phase 2 dose (RP2D) of the combination of niraparib tablet and dostarlimab in paediatric participants
    • Part 1B: to establish the RP2D of the combination of niraparib age-appropriate oral liquid formulation (AAOLF) and dostarlimab in paediatric participants
    E.2.2Secondary objectives of the trial
    Secondary objectives for Part 1 of this study:
    • to evaluate additional measures of anticancer activity including objective response rate (ORR) and duration of response (DOR)
    • to evaluate the safety and tolerability of the combination of niraparib (tablet or AAOLF) and dostarlimab in paediatric participants
    • to characterise the pharmacokinetics (PK) of the combination of niraparib and dostarlimab in paediatric participants
    • to assess the acceptability and palatability of niraparib tablets and AAOLF in paediatric participants
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    • Supplement A: Expansion cohort of participants with osteosarcoma (the “OS cohort”) to assess the antitumour activity of the combination of niraparib and dostarlimab, assessed primarily by the progression-free survival rate at 6 months using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
    The primary objective of this cohort is as follows:
    - to assess the antitumour activity of the combination of niraparib and dostarlimab, assessed primarily by the progression-free survival rate at 6 months (PFS6) (using Response Evaluation Criteria in Solid Tumours [RECIST] v1.1 criteria)
    The secondary objectives of this cohort are as follows:
    - to evaluate additional measures of anticancer activity, including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS)
    - to evaluate the safety of the combination of niraparib (tablet or age-appropriate oral liquid formulation [AAOLF]) and dostarlimab in paediatric participants
    - to characterise the pharmacokinetics (PK) of the combination of niraparib and dostarlimab in paediatric participants
    - to assess the acceptability and palatability of niraparib tablets and AAOLF in paediatric participants
    The exploratory objective of this cohort is as follows:
    - to assess the correlation between clinical outcome and biomarkers related to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition and/or anti-programmed cell death protein 1 (anti-PD-1) therapy


    • Supplement B: Expansion cohort of participants with neuroblastoma (the “NB cohort”) to assess the antitumour activity of the combination of niraparib and dostarlimab, assessed primarily by ORR using International Neuroblastoma Response Criteria (INRC).
    The primary objective of this cohort is as follows:
    - to assess the antitumour activity of the combination of niraparib and dostarlimab, assessed primarily by objective response rate (ORR) (using International Neuroblastoma Response Criteria [INRC])
    Secondary:
    The secondary objectives of this cohort are as follows:
    - to evaluate additional measures of anticancer activity, including duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS)
    - to evaluate the safety of the combination of niraparib (tablet or age-appropriate oral liquid formulation [AAOLF]) and dostarlimab in paediatric participants
    - to characterise the pharmacokinetics (PK) of the combination of niraparib and dostarlimab in paediatric participants
    - to assess the acceptability and palatability of niraparib tablets and AAOLF in paediatric participants
    The exploratory objective of this cohort is as follows:
    - to assess the correlation between clinical outcome and biomarkers related to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition and/or anti-programmed cell death protein 1 (anti-PD-1) therapy
    E.3Principal inclusion criteria
    1. Participant has recurrent or refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing sarcoma, rhabdomyosarcoma, or any other solid tumour (excluding tumours of the CNS) previously documented to have BRCAness mutational signature (mutational signature 3) on DNA sequencing of tumour obtained in the relapsed/recurrent disease setting, within 6 (preferably 3) months prior to enrolment and must not be eligible for local curative treatment. For participants with documented BRCAness mutational signature: Existing information on molecular profiling of the participant’s tumour tissue must be through a molecular profiling platform such as Individualized Therapy for Relapsed Malignancies in Childhood (INFORM). Molecular profile information must contain information from whole exome sequencing or whole genome sequencing, including the mutation status of breast cancer susceptibility gene (BRCA) 1 and BRCA2 and other homologous recombination DNA repair pathway genes, mutational signatures including signature 3, and tumour mutational burden.
    2. Participant is child or adolescent ≥6 months to <18 years old at the time of informed consent/assent.
    3. In order to be eligible to receive the niraparib tablet formulation, participant must be able to swallow the 100 mg niraparib tablet and have a baseline body weight of ≥20 kg. Participants who are unable to swallow the 100 mg niraparib tablet or who have a baseline body weight <20 kg are eligible to receive the niraparib AAOLF only.
    4. Performance status must be ≥70% on the Karnofsky scale for participants >16 years of age and ≥50% on the Lansky scale for participants ≤16 years of age. Note: Neurologic deficits in participants with brain metastases must have been stable for at least 7 days prior to study enrolment. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance status.
    5. Participant has adequate organ function, defined as follows: Note: CBC should be obtained without transfusion or receipt of colony-stimulating factors in the 2 weeks before obtaining sample.
    a. absolute neutrophil count (ANC) ≥1,500/μL
    b. platelets ≥100,000/μL
    c. haemoglobin ≥9 g/dL or ≥5.6 mmol/L
    d. serum creatinine ≤1.5 × upper limit of normal (ULN) for age or calculated creatinine clearance or radioisotope glomerular filtration rate ≥60 mL/min/1.73 m2
    e. total bilirubin ≤1.5 × ULN or direct bilirubin ≤1 × ULN
    f. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN unless liver metastases are present, in which case AST and ALT must be ≤5 × ULN
    g. international normalised ratio or prothrombin time (PT) ≤1.5 × ULN unless the participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
    h. activated PTT ≤1.5 × ULN unless the participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    a. Is not a woman of childbearing potential (WOCBP). or
    b. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, as described in Appendix 3, from the Screening Visit through at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment.
    - A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 72 hours prior to the first dose of study treatment.

    Please review study protocol for further Part 1 inclusion criteria.
    Inclusion criteria for Part 2 of the study are described in each cohort-specific supplement.
    E.4Principal exclusion criteria
    1. Participation presents unacceptable risk to the prospective participant based on the Investigator’s judgment.
    2. Participant has known hypersensitivity to dostarlimab or niraparib, their components, or their excipients.
    3. Participant has a known history of myelodysplastic syndrome (MDS) or AML.
    4. Participant has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
    5. Participant has known active CNS metastases, carcinomatous meningitis, or both. Note: Participants with previously treated brain metastases may participate provided they are clinically stable (without evidence of progression by imaging [using the identical imaging
    modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at
    least 7 days prior to the first dose of study treatment. Carcinomatous meningitis precludes a participant from study participation regardless of clinical stability.
    6. Participant had a known additional malignancy that progressed or required active treatment within the last 2 years.
    7. Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection that requires systemic therapy. Specific examples include, but are not limited to, history of (noninfectious) pneumonitis that required steroids or current pneumonitis, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining assent/consent).
    8. Participant has a condition (such as transfusion-dependent anaemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participant’s participation for the full duration of the study treatment including the following:
    a. Participants who received a transfusion (platelets or red blood cells) within 6 weeks of the first dose of study drug are not eligible.
    b. Participants who received colony-stimulating factors (eg, granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment are not eligible.
    9. Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the Screening Visit through 180 days after the last dose of study treatment. No data are available regarding the presence of dostarlimab or niraparib or its metabolites in human milk, or on its effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions in breastfed infants from dostarlimab and/or niraparib, female participants should not breastfeed during treatment with dostarlimab and/or niraparib and for 1 month after receiving the final dose.
    10. Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
    11. Participant has a known history of HIV (type 1 or 2 antibodies).
    12. Participant has known active hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected).
    13. Participant is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of study treatment.
    14. Participant has had any known Grade 3 or 4 anaemia, neutropenia, or thrombocytopenia due to prior chemotherapy that persisted >4 weeks related to the most recent prior treatment.

    Please review study protocol for further Part 1 exclusion criteria.
    Exclusion criteria for Part 2 of the study are described in each cohort-specific supplement.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1A and 1B: Assess the incidence of DLTs by study part and cohort for the DLT-evaluable population to establish the RP2D of the combination of niraparib (both tablet in Part 1a and age-appropriate oral formulation AAOF in Part 1b) and dostarlimab.

    Part 2: Please refer to the separate cohort-specific supplements for this information.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The DLT observation period is 42 days following the initiation of study treatment (ie, the first 2 treatment cycles) in Part 1
    E.5.2Secondary end point(s)
    • ORR based on Investigator assessment is defined as the proportion of participants with a BOR of confirmed CR or PR as
    determined by the Investigator using RECIST v1.1 or INRC (for participants with neuroblastoma only).
    • DOR is defined as the time from first documentation of response (CR or PR) until the time of first documented PD by RECIST v1.1 or INRC (for participants with neuroblastoma only) based on Investigator assessment or death (whichever occurs first).

    Part 1: Please refers to main study protocol for further Endpoints
    Part 2: Please refer to the separate cohort-specific supplements for this information.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint is included in each Endpoint
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Toxicity - Tolerability - Acceptability and Palatability - Immunogenecity and Exploratory Biomarkers - ORR - ADA
    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 and cohort expansion study
    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 Yes
    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 trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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 end of the study is defined as the date of the last scheduled procedure for the last participant in any part of the study. A participant is considered to have completed the study if he/she has completed all study assessments, including the last scheduled procedure shown in Table 1 for Part 1 and in the SoAs specific to the cohorts provided in the supplements
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    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: 116
    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: 33
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 33
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 116
    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 Decision2020-10-29
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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