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    Summary
    EudraCT Number:2019-001828-36
    Sponsor's Protocol Code Number:ABP-2019
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-30
    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 number2019-001828-36
    A.3Full title of the trial
    Advancing Brigatinib Properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients
    by deep phenotyping
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Advancing Brigatinib Properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients
    by deep phenotyping
    A.3.2Name or abbreviated title of the trial where available
    ABP
    A.4.1Sponsor's protocol code numberABP-2019
    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 SponsorInstitut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Pharmaceutical Company Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    B.5.2Functional name of contact pointIKF
    B.5.3 Address:
    B.5.3.1Street AddressSteinbacher Hohl 2-26
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60488
    B.5.3.4CountryGermany
    B.5.4Telephone number00496976014165
    B.5.5Fax number00496976013655
    B.5.6E-maileickhoff.regina@ikf-khnw.de
    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 Yes
    D.2.1.1.1Trade name Alunbrig
    D.2.1.1.2Name of the Marketing Authorisation holderTakea Pharma
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBrigatinib
    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 INNBRIGATINIB
    D.3.9.3Other descriptive nameBRIGATINIB
    D.3.9.4EV Substance CodeSUB184911
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAlecensa
    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 INNALECTINIB
    D.3.9.1CAS number 1256580-46-7
    D.3.9.3Other descriptive nameALECTINIB
    D.3.9.4EV Substance CodeSUB178557
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameZykadia
    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 INNCeritinib
    D.3.9.1CAS number 1032900-25
    D.3.9.3Other descriptive nameCERITINIB
    D.3.9.4EV Substance CodeSUB130802
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC)
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung 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 PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the efficacy of brigatinib in the 1st-line use to that of any other 2nd-generation TKI (PFS 1st-line treatment)
    E.2.2Secondary objectives of the trial
    · PFS 2nd-line treatment
    · Comparison of the efficacy of brigatinib in the 1st-line use to that of any other TKI as evidenced by TNT 1st line (TNT 1st line, defined as the time from begin of 1st-line treatment until begin of 2nd-line treatment)
    · Comparison of the efficacy of brigatinib in the 1st-line use to that of any other TKI as evidenced by TNT 2nd line (TNT2, defined as time from begin of 2nd line until begin of 3rd-line treatment)
    · Comparison of the efficacy of brigatinib in the 1st-line use to that of any other TKI as evidenced by TNT1/2 (defined as time from begin of 1st-line treatment until begin of 3rd-line treatment)
    · Overall survival (OS)
    · Efficacy in the CNS (“brain control”)
    o intracranial ORR (iORR)
    o intracranial DOR (iDOR)
    o time to intracranial progression (TTiP)
    · QoL with SF-12 and EORTC-QLQ-BN20
    · Safety and tolerability of brigatinib in the 1st-line use to that of any other TK
    · Biomarker analyses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Fully informed written consent and any locally-required authorization (EU Data Privacy Directive) given by the patient
    2. Male or female ≥ 18 years of age
    NOTE: There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.
    3. Histologically confirmed, locally advanced (stage III) and not suitable for curative treatment, i.e. R0 operation or definitive chemo-/radiation, or metastatic (stage IV) ALK+ NSCLC
    NOTE: Documentation of ALK rearrangement by a positive result of any ALK assay approved in Germany [i.e. positivity for at least one of the three: immunohistochemistry (IHC), NGS, fluorescence in situ hybridisation (FISH)] must be available at baseline. Treatment can already be started based on a local ALK+ test result, but subsequent central testing of the baseline biopsy for molecular profiling incl. determination of ALK variant and TP53 status should be made possible for all patients.
    4. No prior therapy for metastatic ALK+ NSCLC including therapy with ALK inhibitors. However, 1 or 2 cycles of chemotherapy as well as cerebral irradiation before inclusion in the study will be allowed.
    5. At least 1 measurable (i.e., target) lesion per RECIST v1.1
    6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    7. Have adequate organ function, as determined by:
    • Total bilirubin ≤1.5x the upper limit of the normal range (ULN)
    (< 3x the ULN if Gilbert’s disease is present)
    • Estimated glomerular filtration rate ≥30 mL/minute/1.73 m2
    (calculated by MDRD or any other validated formula, see Appendix 13.4)
    • Alanine aminotransferase/aspartate aminotransferase ≤2.5x ULN
    NOTE: ≤5x ULN is acceptable if liver metastases are present.
    • Serum lipase ≤1.5x ULN
    • Platelet count ≥75x 109/L
    • Hemoglobin ≥9 g/dL
    • Absolute neutrophil count ≥1.5x 109/L
    8. Willingness and ability to comply with scheduled visit and study procedures
    9. Patient willing to participate in accompanying research program
    10. Collection of current biopsy during screening must be feasible
    NOTE: For each patient a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block must be available for biomarker evaluation. Excisional, incisional or core needle biopsies are appropriate, while fine needle aspirations are insufficient.
    11. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to randomization. Women must not be breastfeeding.
    12. Female patients who
    - Are postmenopausal for at least 1 year before the screening visit, OR
    - Are surgically sterile, OR
    - If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
    Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
    - Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
    - Agree to completely abstain from heterosexual intercourse.
    E.4Principal exclusion criteria
    1. History or presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis
    2. Uncontrolled hypertension, defined as hypertension treated* with anti-hypertensive drugs AND blood pressure ≥ 160 mmHg (systolic) or ≥ 100 mmHg (diastolic) in repeated measurements. Untreated elevated blood pressure is not an exclusion criterion and should receive adequate anti-hypertensive adjustment.
    *Please note: In case of treatment, at least 3 anti-hypertensive drugs should have been used with the intention to control hypertensive disease
    3. Systemic treatment with strong cytochrome P-450 (CYP) 3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers or treatment with any investigational systemic anticancer agents, chemotherapy or radiation therapy (except for stereotactic radiosurgery or stereotactic body radiation therapy) within 14 days of randomization
    4. Treatment with antineoplastic monoclonal antibodies within 30 days of randomization
    5. Major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.
    6. Current spinal cord compression (symptomatic or asymptomatic) as detected by radiographic imaging. Patients with leptomeningeal disease without cord compression are allowed.
    7. Significant or uncontrolled cardiovascular disease, specifically including, but not restricted to the following:
    • If an acute coronary syndrome has ensued in the past 6 months, successful reperfusion has to be documented and the patient has to be free of symptoms.
    • New York Heart Association Class III or IV heart failure within 6 months prior to randomization
    • Any history of clinically significant ventricular arrhythmia
    8. Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose of study drug
    9. Malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug
    10. Active severe or uncontrolled chronic infection, including but not limited to, the requirement for intravenous antibiotics for longer than 2 weeks
    11. History of HIV infection. Testing is not required in the absence of history.
    12. Chronic hepatitis B (surface antigen-positive) or chronic active hepatitis C infection. Testing is not required in the absence of history.
    13. Any serious medical condition or psychiatric illness that could, in the investigator’s opinion, potentially compromise patient safety or interfere with the completion of treatment according to this protocol
    14. Known or suspected hypersensitivity to brigatinib or other TKI or their excipients
    15. Life-threatening illness unrelated to cancer
    16. Involvement in the planning and/or conduct of the study (applies to both Takeda staff and/or staff of sponsor and study site)
    17. Patient who might be dependent on the sponsor, site or the investigator
    18. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG]
    19. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG]
    20. Legal incapacity or limited legal capacity
    21. Females who are pregnant or breastfeeding
    22. Patients who have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.
    23. Rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
    E.5 End points
    E.5.1Primary end point(s)
    PFS 1st-line treatment is defined as the time from the first dosing date of any study medication to the date of the first objectively documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause. Subjects who did not progress or die will be censored on the date of their last tumor assessment. Subjects who did not have any on study tumor assessments and did not die will be censored on the first dosing date of study medication. Subjects who started 2nd-line treatment or any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After LPLV, approx. Q3 / 2025
    E.5.2Secondary end point(s)
    · PFS 2nd-line treatment (RECIST v1.1) is defined as the time from the first dosing date of any 2nd-line TKI to the date of the objectively documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause. Subjects who did not progress or die will be censored on the date of their last tumor assessment. Subjects who did not have any on study tumor assessments and did not die will be censored on the first dosing date of study medication. Subjects who started 2nd-line treatment or any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy.
    · TNT 1st line (TNT1, i.e. time-to-next treatment for the 1st line, defined as the time from begin of 1st-line treatment until begin of 2nd-line treatment)
    · TNT 2nd line (TNT2, i.e. time-to-next treatment for the 2nd line, defined as time from begin of 2nd line until begin of 3rd-line treatment)
    · TNT1/2 (time-to-next treatmemt for the 1st and 2nd line together, defined as time from begin of 1st-line treatment until begin of 3rd-line treatment)
    · Overall survival (OS), defined as the time from treatment start in the 1st line to the date of death (due to any cause). Subjects without death events will be censored at the last date known alive.
    · Efficacy in the CNS (“brain control”) of 1st- and 2nd-line treatment assessed by applying RECIST v1.1 criteria
    o intracranial ORR (iORR), defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented intracranial tumor progression per RECIST criteria or the date of subsequent therapy or death, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination.
    o intracranial DOR (iDOR), defined as the time from documentation of CR or PR according to RECIST v1.1 (whichever is first recorded) until the first date that the intracranial PD is objectively documented or until death (whichever occurs first).
    o time to intracranial progression (TTiP), defined as the time from start of 1st-line treatment until the occurrence of a new CNS lesion or progression of pre-existing CNS lesions (adjusted for the two competing events “death” and “extracranial progression inducing a change in ALK inhibitor treatment")
    · QoL assessed with SF-12 and EORTC-QLQ-BN20
    (EORTC-QLQ-BN20 in case of brain metastases, only)
    · Safety and tolerability including type, incidence and severity of AEs, SAEs

    Exploratory Endpoints:
    · Capturing ALK fusion variants, TP53 mutation status and „acquired resistance“ mutations via standardized NGS-based multiplex analysis
    · Efficacy of treatment according to ALK fusion variant and TP53 status
    · Molecular resistance patterns after 1st-line failure
    · Impact of 2nd-line treatment after failure of 1st line as defined
    · Clinical utility of cerebrospinal fluid ctDNA analysis in “brain-only” progression
    E.5.2.1Timepoint(s) of evaluation of this end point
    After LPLV, approx. Q3 / 2025
    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 No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 Yes
    E.8.1.7Other No
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state116
    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)
    After the end of study, patients will be treated according to standard-of-care at the descrition of the investigator.
    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 Decision2020-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status of studies in GB is no longer updated from 1.1.2021
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