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    Summary
    EudraCT Number:2015-000221-37
    Sponsor's Protocol Code Number:Pevonedistat-2001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-07
    Trial results View 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-000221-37
    A.3Full title of the trial
    A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous Leukemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Compare the Effectiveness and Safety of Azacitidine Versus Pevonedistate Plus Azacitidine in Adults with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous Leukemia
    A.4.1Sponsor's protocol code numberPevonedistat-2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02610777
    A.5.4Other Identifiers
    Name:P-2001Number:Informal shortened named of protocol code
    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 SponsorMillennium Pharmaceuticals, Inc. (Takeda)
    B.1.3.4CountryUnited States
    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 supportMillennium Pharmaceuticals, Inc. (Takeda)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015107402412
    B.5.5Fax number0018008816092
    B.5.6E-mailmedical@mlnm.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 namePevonedistat
    D.3.2Product code MLN4924 (TAK-924)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPevonedistat Hydrochloride
    D.3.9.1CAS number 1160295-21-5
    D.3.9.2Current sponsor codeMLN4924-003
    D.3.9.4EV Substance CodeSUB179279
    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: 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.2.1.1.1Trade name Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/509, EU/3/01/084
    D.3 Description of the IMP
    D.3.1Product nameAzacitidine
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    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
    Higher-risk myelodysplastic syndromes (MDS),
    Chronic myelomonocytic leukemia (CMML),
    Low-blast acute myelogenous leukemia (AML)
    E.1.1.1Medical condition in easily understood language
    Myelodysplastic syndromes (MDS) are characteristed by changes to blood composition including reductions in red and white blood cells and platelets.
    Leukaemia is cancer of the white blood cells.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054350
    E.1.2Term Chronic myelomonocytic leukemia
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10024348
    E.1.2Term Leukemia myelogenous
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10024330
    E.1.2Term Leukemia acute
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067387
    E.1.2Term Myelodysplastic syndrome transformation
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10009018
    E.1.2Term Chronic myelomonocytic leukaemia
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    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 in patients with higher-risk myelodysplastic syndrome (HR MDS)or CMML and low-blast acute myelogenous leukemia (AML) whether the combination of pevonedistat and azacitidine improves overall survival (OS) when compared to single-agent azacitidine.
    E.2.2Secondary objectives of the trial
    To determine in patients with HR MDS or CMML and low-blast AML, whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared to single-agent azacitidine.
    To determine in patients with HR MDS, CMML and low-blast AML whether the combination of pevonedistat and azacitidine improves 6-month and 1-year survival rates when compared to single-agent azacitidine.
    To determine in patients with HR MDS and CMML whether the combination of pevonedistat and azacitidine delays time to AML transformation when compared to single-agent azacitidine.
    To determine in patients with HR MDS, CMML, and low-blast AML whether the combination of pevonedistat and azacitidine, when compared to single-agent azacitidine, improves the rate of complete remission (CR) (composite CR {CR+CRi} in patients with low-blast AML) , CR plus partial remission (CR+PR) composite CR+PR for patients with low-blast AML, overall response and/or CR (not including CRi) in low-blast AML.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years or older.

    2. Morphologically confirmed diagnosis of MDS, nonproliferative CMML (ie, with WBC <20,000/μL), or low-blast AML based on 1 of the following:
    French-American-British (FAB) Classifications:
    - Refractory anemia with excess blasts (RAEB – defined as having 5% to 20% myeloblasts in the bone marrow).
    - CMML with 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood.
    OR
    World Health Organization (WHO) Classifications:
    - Refractory anemia with excess blasts-1 (RAEB-1 – defined as having 5% to 9% myeloblasts in the bone marrow).
    - Refractory anemia with excess blasts-2 (RAEB-2 – defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood).
    - Chronic Myelomonocytic Leukemia-2 (CMML-2 – defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood).
    - Chronic Myelomonocytic Leukemia-1 (Although CMML-1 is defined as having <10% myeloblasts in the bone marrow and/or <5% blasts in the blood, these patients may enroll only if bone marrow blasts ≥5%).
    - WHO-defined AML with 20% to 30% myeloblasts in the bone marrow (defined in this protocol as “Low-Blast AML”) and < 30% myeloblasts in peripheral blood who are considered by investigator to be appropriate for azacitidine-based therapy.

    3. For patients with MDS and CMML patients, prognostic Risk Category, based on the Revised International Prognostic Scoring System (IPSS-R):
    - Very high (>6 points),
    - High (>4.5 - 6 points), or
    - Intermediate (>3 – 4.5 points): a patient determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of ≥5% bone marrow myeloblasts.
    Patients with indeterminate cytogenetics findings at Screening should be assigned a cytogenetics prognostic variable of 2 points (ie, intermediate) for determining overall Prognostic Risk Category/Score

    4. ECOG performance status of 0 to 2

    5. Clinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug):
    - Albumin >2.7 g/dL.
    - Total bilirubin <upper limit of normal (ULN) except in patients with Gilbert’s
    syndrome. Patients with Gilbert’s syndrome may enroll if direct bilirubin ≤ 1.5 x
    ULN of the direct bilirubin.
    - ALT and AST <2.5 × ULN.
    - Creatinine clearance >50 mL/min
    - Hemoglobin >8 g/dL. Patients may be transfused to achieve this value. Elevated indirect bilirubin due to post-transfusion hemolysis is allowed.

    6. For patients with CMML : WBC count <20,000/μL before administration of the first dose of study drug on Cycle 1 Day 1; patients must have been off hydroxyurea for at least 1 week prior to WBC count assessment.

    7. Ability to undergo the study-required bone marrow sample collection procedures.

    8. Suitable venous access for the study-required blood sampling (ie, including PK and biomarker sampling).

    9. 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 1 highly effective method
    and 1 additional effective (barrier) method 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 practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)

    Male patients, even if surgically sterilized (ie, status postvasectomy), 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 practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)

    10. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
    E.4Principal exclusion criteria
    1. Previous treatment with decitabine or azacitidine or other hypomethylating agent.

    2. Acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis.

    3. Eligible for allogenic stem cell transplantation.

    4. Patients with MDS, CMML, or low-blast AML, whose only site of disease is
    extramedullary, eg, the skin.

    5. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of study procedures or could limit patient expected survival to less than 6 months.

    6. Treatment with any anti-leukemic/anti-MDS therapies (eg, lenalidomide, cytarabine, anthracyclines, purine analogs) or with any investigational products within 14 days before the first dose of any study drug.

    7. Known hypersensitivity to mannitol.

    8. Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.

    9. Major surgery within 14 days before first dose or a scheduled surgery during study period; insertion of a venous access device (eg, catheter, port) is not considered major surgery.

    10. Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.

    11. Life-threatening illness unrelated to cancer.

    12. Prothrombin time (PT) or aPTT > 1.5 ULN or active uncontrolled coagulopathy or bleeding disorder.

    13. Known human immunodeficiency virus (HIV) seropositive.

    14. Known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Patients who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.

    15. Known hepatic cirrhosis or severe pre-existing hepatic impairment.

    16. Known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association [NYHA] Class III or IV; see Section 15.3), and/or myocardial infarction within 6 months prior to first dose, or severe pulmonary hypertension. As an example, well-controlled atrial fibrillation would not be an exclusion whereas uncontrolled atrial fibrillation would be an exclusion.

    17. Treatment with strong CYP3A inhibitors or inducers within 14 days before the first dose of pevonedistat.

    18. Systemic antineoplastic therapy or radiotherapy for other malignant conditions within
    12 months before the first dose of any study drug, except for hydroxyurea.

    19. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.

    20. Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s).

    21. Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s).
    E.5 End points
    E.5.1Primary end point(s)
    OS (Overall Survival)
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS will be calculated from date of randomization to the date of patient death.
    E.5.2Secondary end point(s)
    - EFS (Event-free survival); for patients with HR MDS or CMML, an event is defined as death or transformation to AML; for patients with low-blast AML, an event is defined as death.
    - Six-month and 1-year survival rates.
    - Time to AML transformation in patients with HR MDS or CMML;
    - CR (CR for HR MDS and CMML; CR + CRi [composite CR] for low-blast AML), CR (CR for HR MDS and CMML; CR + CRi for low-blast AML) + PR, overall response (CR + PR + HI for HR MDS and CMML; CR + CRi + PR for low-blast AML), CR (not including CRi) in low-blast AML.
    - CR (CR for HR MDS and CMML; CR + CRi [composite CR] for low-blast AML), CR (CR for HR MDS and CMML; CR + CRi for low-blast AML) + PR, overall response (CR + PR + HI for HR MDS and CMML; CR + CRi + PR for low-blast AML) by Cycle 4, CR (not including CRi) in low-blast AML by Cycle 4.
    - Duration of CR (CR for HR MDS and CMML, CR + CRi [composite CR] for lowblast AML), CR (CR for HR MDS and CMML; CR + CRi for low-blast AML) + PR, overall response (CR + PR + HI for HR MDS and CMML; CR + CRi + PR for low-blast AML), and duration of CR (not including CRi) in low-blast AML.
    - Time to first CR (CR for HR MDS/CMML and low-blast AML; CR + CRi [composite CR] for low-blast AML) or PR for HR MDS/CMML and low-blast AML.
    - Time to subsequent therapy.
    - RBCs and platelet-transfusion independence.
    - Percentage of patients with at least 1 inpatient hospital admission related to HR MDS or CMML (collected through transformation to AML or until initiation of subsequent therapy, whichever occurs first) or low-blast AML (collected through AML progression or until initiation of subsequent therapy, whichever occurs first).
    - Time to PD, relapse, or death.
    - AEs and serious adverse events (SAEs), abnormal clinical laboratory values, Eastern Cooperative Oncology Group (ECOG) performance status, ECGs, and vital sign measurements.
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS will be calculated from date of randomization to the date of patient death.
    Six-month survival rate is defined as the percentage of patients who are still alive six months after randomization.
    One-year survival rate is defined as the percentage of patients who are still alive one year after randomization.
    Time to AML transformation is defined as time from randomization to documented AML transformation.
    Time to first CR or PR is defined as time from randomization to first documented CR or PR, whichever occurs first.
    Time to subsequent therapy is defined as time from randomization to the date of the first subsequent therapy.
    Time to PD, relapse , or death is defined as the time from randomization until disease progression, or relapse, or death
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Ireland
    Israel
    Italy
    Netherlands
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV - Patients will be considered to have completed the study if they are followed until death or until the sponsor terminates the study.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 101
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 117
    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 subjects have ended participation in the study, they will be treated as per local standard of care.
    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 Decision2016-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-23
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