Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35535   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001454-18
    Sponsor's Protocol Code Number:UG1617
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-19
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-001454-18
    A.3Full title of the trial
    T cell therapy for patients with advanced Renal Cell Carcinoma
    T celle terapi til patienter med metastisk renalcelle karcinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    T Cell based treatment for patients with Renal Cell Carcinoma
    Videnskabeligt forsøg med behandling af nyrekræft med spredning med T-celle terapi
    A.4.1Sponsor's protocol code numberUG1617
    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 SponsorCenter for Cancer Immune Therapy
    B.1.3.4CountryDenmark
    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 supportCenter for Cancer Immune Therapy
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportHerlev Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danish Cancer Society / Kræftens Bekæmpelse
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Cancer Immune Therapy
    B.5.2Functional name of contact pointCenter for Cancer Immune Therapy
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.6E-mailmagnus.pedersen@regionh.dk
    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 nameTumor infiltrating Lymphocytes
    D.3.2Product code TIL
    D.3.4Pharmaceutical form 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 INNTIL
    D.3.9.3Other descriptive nameAUTOLOGOUS T-LYMPHOCYTES
    D.3.9.4EV Substance CodeSUB96123
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5000000000 to 200000000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sendoxan (cyclophosphamide)
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameSendoxan
    D.3.4Pharmaceutical form 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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fludara (fludarabin phosphate)
    D.2.1.1.2Name of the Marketing Authorisation holderActavis
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameFludara
    D.3.4Pharmaceutical form 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 INNFLUDARABINE PHOSPHATE
    D.3.9.1CAS number 75607-67-9
    D.3.9.4EV Substance CodeSUB13897MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 Proleukin (aldesleukin)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameProleukin
    D.3.4Pharmaceutical form 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 INNINTERLEUKIN-2
    D.3.9.1CAS number 8000048-25-1
    D.3.9.4EV Substance CodeSUB14225MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number675000000
    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 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
    Advanced Renal Cell Carcinoma
    Metastatisk Nyrecancer
    E.1.1.1Medical condition in easily understood language
    Renal Cell Carcinoma
    Nyrekræft
    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 10038409
    E.1.2Term Renal cell carcinoma NOS
    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
    To evaluate toxicity (according to CTCAE version 4.0) and feasibility.
    At evaluere bivirkninger (ifølge CTCAE version 4.0) og gennemførlighed.
    E.2.2Secondary objectives of the trial
    To evaluate treatment related immune responses
    To evaluate clinical response (according to RECIST 1.1 - response rate,
    progressionfree survival and overall survival)
    At evaluere behandlingsrelateret immunresponser
    At evaluere klinisk respons (ifølge RECIST 1.1 - responsrate,
    progressionsfri overlevelse og samlet overlevelse)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological proven mRCC with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must include a clear cell component with or without a sarcomatoid dedifferentiation.
    2. Metastatic disease irrespective of number of previous treatment lines. Treatment naïve pt’s can be included.
    3. Age: 18 – 70 years.
    4. ECOG performance status of ≤1.
    5. IMDC prognostic group ‘Favorable’ or ‘Intermediary’
    6. Life expectancy of > 6 months.
    7. At least one measurable parameter after surgery in accordance with RECIST 1.1 –criteria’s.
    8. No significant toxicities or side effects (CTC ≤ 1) from previous treatments.
    9. Normal ejection fraction (EF) measured by a multigated acquisition (MUGA) scan.
    10. Crom EDTA clearance >40 ml/min
    11. Sufficient organ function.
    12. LDH ≤ 5 times upper normal limit as a measure of tumor burden
    13. Women in the fertile age must use effective contraception. Likewise, men included in the study, as well as their partners, must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives.
    14. Signed statement of consent after receiving oral and written study information. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research
    15. Willingness to participate in the planned controls.
    1. Histologisk verificeret metastatisk RCC med mulighed for kirurgisk fjernelse af tumorvæv på > 1 cm3. Histologien skal indeholde en clear celle komponent med eller uden sarkomatoid dedifferentiering.
    2. Metastatisk sygdom uanset antallet af tidligere behandlinger. Behandlingsnaive patienter kan inkluderes.
    3. Alder 18-70 år.
    4. ECOG performance status < 1.
    5. IMDC prognostisk gruppe 'Favorabel' eller 'Intermediær'.
    6. Forventet levetid > 6 måneder.
    7. Mindst et målbart parameter efter kirurgi i henhold til RECIST 1.1 kriterierne.
    8. Ingen signifikant toxicitet eller bivirkninger (CTC ≤ 1) fra tidligere behandlinger.
    9. Normal uddrivelsesfraktion (EF) målt ved MUGA
    10. Crom EDTA clearance >40 ml/min
    11. Sufficient organ funktion.
    12. LDH ≤ 5 gange over øvre normalgrænse som mål for tumorbyrde.
    13. Kvinder i den fertile alder skal benytte sikker antikonception. Det samme skal mænd og deres partnere. Dette gælder fra inklusion til 6 måneder efter behandlingen.
    14. Underskrevet samtykke efter mundtlig og skriftlig forsøgsinformation.
    15. Patienten skal være villig til at deltage i de planlagte kontroller og i stand til at håndtere toxicitet.
    E.4Principal exclusion criteria
    1. A history of prior malignancies, exept curatively treated non-melanoma skin cancer and CIS of the cervix uteri. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 3 years after treatment.
    2. Patients with cerebral metastases.
    3. Patients with widespread bone or bone only metastases.
    4. Known hypersensitivity to one of the active drugs or one or more of the excipients.
    5. Severe medical conditions, such as severe asthma/COLD, ischemic hearth disease/significant cardiac disease (e.g. NYHA class ≥2), poorly regulated insulin dependent diabetes mellitus among others, which can interfere with patient compliance and/or significantly increase the risk of side effects upon investigators clinical judgement.
    6. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others.
    7. Severe allergies or previous anaphylactic reactions.
    8. Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosis, Sjögren’s syndrome, sclerodermia, myasthenia gravis, Goodpasteur’s disease, Addison’s disease, Hashimotos thyroiditis, active Graves disease.
    9. Pregnant women and women breastfeeding.
    10. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others).
    11. Simultaneous treatment with other experimental drugs.
    12. Simultaneous treatment with other systemic anti-cancer treatments.
    13. Patients with active and uncontrollable hypercalcaemia.
    1. Tidligere cancer undtagen kurativt behandlet ikke-melanom hudkræft og CIS i cervix uteri.
    2. Patienter med cerebrale metastaser.
    3. Patienter med udbredte knoglemetastaser eller kun knoglemetastaser.
    4. Kendt hypersensitivitet til et af de aktive stoffer eller en/flere af hjælpestofferne.
    5. Alvorlig komorbiditet, som eksempelvis svær astma/KOLD, iskæmisk hjertesygdom/signifikant hjertesygdom, dårligt reguleret insulin-afhængig sukkersyge, som kan påvirke patient compliance og/eller signifikant øge risikoen for bivirkninger efter investigators kliniske vurdering.
    6. Akut/kronisk infektion med HIV, hepatitis, tuberkulose blandt andre.
    7. Alvorlige allergier eller tidligere anafylaktiske reaktioner.
    8. Aktiv autoimmun sygdom, eksempelvis autoimmun neutropeni/trombocytopeni eller hæmolytisk anæmi, lupus erythematosis, sjögrens syndrom, sclerodermi, myasthenia gravis, Goodpasteur’s sygdom, Addison’s sygdom, Hashimotos thyroiditis, aktiv Graves sygdom.
    9. Gravide kvinder og kvinder der ammer.
    10. Samtidig behandling med systemiske immunsupprimerende stoffer
    (herunder prednisolon, methotrexat blandt andre).
    11. Samtidig behandling med andre eksperimentelle stoffer.
    12. Samtidig behandling med andre systemiske anti-cancer
    behandlinger.
    13. Patienter med aktiv og ukontrollerbar hypercalcæmi.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is toxicity (according to CTCAE 4.0).
    Det primære endepunkt er bivirkninger (ifølge CTCAE 4.0).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated before treatment, during
    treatment and at follow-up visits untill 6 months after treatment.
    Det primære endepunkt vil blive evalueret før behandling, under
    behandling og ved opfølgende besøg op til 6 måneder efter behandling.
    E.5.2Secondary end point(s)
    Secondary endpoints are treatment related immune response and clinical response (according to RECIST 1.1 - response rate, progressionfree
    survival and overall survival).
    Sekundære endepunkter er behandlingsrelateret immunrespons og
    klinisk respons (ifølge RECIST 1.1 - responsrate, progressionsfri
    overlevelse og samlet overlevelse).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated after all patients have
    received treatment and clinical response is evaluated. Estimated 1 year
    after treatment of last patient.
    De sekundære endepunkter vil blive evalueret efter at alle patienter har
    modtaget behandling og klinisk respons er vurderet. Estimeret 1 år efter
    sidste patients behandling.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States 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
    Sidste patients sidste besøg
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state6
    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)
    That depends on the condition of the patient at the time.
    Det afhænger af patientens tilstand på det givne tidspunkt.
    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 Decision2016-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-05
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA