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    Summary
    EudraCT Number:2017-000758-20
    Sponsor's Protocol Code Number:DIV-SCLC-301
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-08
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2017-000758-20
    A.3Full title of the trial
    A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer
    Dvojdielne, otvorené, randomizované klinické skúšanie fázy II/III na porovnanie dinutuximabu a Irinotecanu s Irinotecanom ako liečby druhej línie u účastníkov s relapsujúcim alebo
    refraktérnym malobunkovým karcinómom pľúc
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A two part Open-Label, Randomized, Phase II/III clinical study to examine how safe and how well Dinutuximab works on it’s own or in combination with Irinotecan when treating patients with small cell lung cancer that is unresponsive or no longer responding to previous treatment
    A.4.1Sponsor's protocol code numberDIV-SCLC-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03098030
    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 SponsorUnited Therapeutics Corporation
    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 supportUnited Therapeutics Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrecision Oncology
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street Address200 Route 31 North, Suite 102
    B.5.3.2Town/ cityFlemington
    B.5.3.3Post codeNJ 08822
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908237 3227
    B.5.5Fax number+1908292 1127
    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 nameUnituxin
    D.3.2Product code Dinutuximab
    D.3.4Pharmaceutical form Solution for injection/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 INNDINUTUXIMAB
    D.3.9.2Current sponsor codeDINUTUXIMAB
    D.3.9.4EV Substance CodeSUB130362
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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 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 Irinotecan
    D.2.1.1.2Name of the Marketing Authorisation holderSeacross Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameIrinotecan
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNIrinotecan
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB45873
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.2.1.1.1Trade name Potactasol
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    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 nameTopotecan
    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 INNTOPOTECAN
    D.3.9.1CAS number 123948-87-8
    D.3.9.4EV Substance CodeSUB11191MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 4
    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 Topotecan
    D.2.1.1.2Name of the Marketing Authorisation holderHospira
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameTopotecan
    D.3.4Pharmaceutical form Solution 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 INNTOPOTECAN
    D.3.9.1CAS number 123948-87-8
    D.3.9.4EV Substance CodeSUB11191MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    relapsed or refractory small cell lung cancer (SCLC)
    E.1.1.1Medical condition in easily understood language
    small cell lung cancer that is unresponsive or no longer responding to previous treatment
    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 10041067
    E.1.2Term 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to compare overall survival (OS) in subjects treated with dinutuximab and irinotecan versus subjects treated with irinotecan alone as a second-line treatment for relapsed or refractory small cell lung cancer (SCLC).
    E.2.2Secondary objectives of the trial
    • To compare progression-free survival (PFS), objective response rate (ORR) (complete response [CR] + partial response [PR]) and clinical benefit rate (CR + PR + stable disease [SD]) in subjects treated with dinutuximab and irinotecan versus subjects treated with irinotecan alone.
    • To compare the safety of subjects treated with dinutuximab and irinotecan versus subjects treated with irinotecan alone.
    • To evaluate the pharmacokinetics of subjects treated with dinutuximab.
    • To compare OS, PFS, ORR, and clinical benefit rate (CBR) in subjects treated with dinutuximab and irinotecan versus subjects treated with topotecan alone.

    The exploratory objective of the study is to assess the relationship between selected biomarkers and survival of subjects treated with dinutuximab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Provide a signed informed consent form before any screening procedures.
    • Aged ≥18 years on the date of signing the informed consent form.
    • Have histologically or cytologically confirmed SCLC (undifferentiated small cell carcinoma arising in or consistent with lung cancer origin).
    • Documented (radiographic evidence of) relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
    • No more than 1 prior regimen for SCLC. First-line platinum-based therapy followed by maintenance therapy is considered a single regimen provided there is no intervening disease progression
    • Have no curative therapy available.
    • Have a life expectancy of at least 12 weeks.
    • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Have adequate bone marrow function as assessed by the following laboratory test results:
    − Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (erythropoietin or transfusion permitted)
    − Absolute neutrophil count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L (growth factors permitted)
    − Platelet count ≥100,000/mm3 or ≥100 x 109/L (transfusions or thrombopoietic growth factors permitted).
    • Have calculated creatinine clearance (CrCL) ≥30 mL/minute (using Cockcroft and Gault's formula) or serum creatinine ≤1.5 times below the ULN.
    • Have adequate hepatic function, as assessed by the following laboratory test results:
    − Total bilirubin ≤1.5 times the ULN. (Subjects with Gilbert's Syndrome or other benign congenital hyperbilirubinemia may be eligible at the Investigator's discretion in consultation with the Medical Monitor.)
    - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times ULN in subjects without liver metastases or ≤5.0 times ULN in subjects with liver metastases.
    • Women of reproductive potential must have a negative urine or serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 days prior to the first dose of study treatment (dinutuximab and/or chemotherapy)
    − Women not of reproductive potential are female subjects who are postmenopausal or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
    • Women of reproductive potential must agree to consistently use one form of highly effective contraception plus one additional form of contraception simultaneously or to practice complete abstinence from vaginal intercourse. The requirement for two forms of contraception or complete abstinence from vaginal intercourse applies from the time of
    informed consent until 90 days following the last dose of all study drugs.
    Male subjects who are sexually active with a woman of reproductive potential must agree to use a condom from the time of informed consent until 90 days following the last dose of all study drugs.
    The following are examples of highly effective and additional methods of contraception:
    Highly effective methods (must use one):
    • Hormonal associated with inhibition of ovulation (oral, injectable, implantable, intravaginal, transdermal)
    • Intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Tubal ligation
    • Vasectomy for partner
    Additional effective methods (must use one):
    • Male or female condom with or without spermicide
    • Cap, diaphragm or sponge with spermicide
    • Combination of male condom with either cap, diaphragm or sponge
    with spermicide (double barrier methods)
    E.4Principal exclusion criteria
    • Candidate for re-treatment with original platinum-based regimen as second-line therapy.
    • Prior treatment with irinotecan, topotecan or dinutuximab.
    • Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation. Subjects in whom steroids are being tapered may be eligible with prior approval of the Medical Monitor.
    • Have mixed small-cell and non-small-cell histologic features.
    • Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated <3 years ago.
    • Have a history or current evidence of uncontrolled cardiovascular disease including but not limited to the following conditions:
    − Congestive heart failure of New York Heart Association (NYHA) grade 3 or greater.
    − Unstable angina (symptoms of angina at rest) or newonset angina within 6 months.
    − Arterial thrombosis, deep vein thrombosis, or pulmonary embolism within 6 months.
    − Myocardial infarction or stroke within 6 months.
    − Pericarditis (any CTCAE v.4.03 grade), pericardial effusion (CTCAE v4.03 Grade ≥2).
    • Have a history of atypical thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS).
    • Women who are pregnant or breast-feeding.
    • Have not recovered from prior surgery, significant trauma, systemic anticancer therapy (eg chemotherapy, biologic therapy, immunotherapy), radiation therapy or investigational therapy to Grade 1 or better toxicity prior to enrollment (Part 1) or randomization (Part 2).
    • Have had organ allograft or hematopoietic transplantation.
    • Known to be human immunodeficiency virus (HIV) positive.
    • Have an active infection requiring treatment or one that is clinically serious in the Investigator's opinion.
    • Have received a live vaccine within 6 months of enrollment (Part 1) or randomization (Part 2).
    • Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
    • Have any clinical condition that is considered unstable or might jeopardize the safety of the subject and / or influence the subject's compliance in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is overall survival (OS)

    E.5.1.1Timepoint(s) of evaluation of this end point
    Through out the trial.
    E.5.2Secondary end point(s)
    Secondary endpoints will be tested in the following sequence:
    • PFS
    • ORR
    • CBR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through out the trial.
    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 No
    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) 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) Yes
    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 trial3
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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
    Bulgaria
    Canada
    France
    Georgia
    Germany
    Hong Kong
    Hungary
    Italy
    Korea, Republic of
    Lithuania
    Malaysia
    New Zealand
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Thailand
    Ukraine
    United Kingdom
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 370
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 485
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-27
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