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   41499   clinical trials with a EudraCT protocol, of which   6826   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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:2018-004248-49
    Sponsor's Protocol Code Number:NL69508.058.19
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004248-49
    A.3Full title of the trial
    Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma (CHOPIN)
    Fase 1b/2 studie naar de combinatie van leverperfusie met ipilimumab en nivolumab voor de behandeling van uitgezaaid oogmelanoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for patients with metastatic uveal melanoma, in which treatment with ipilimumab and nivolumab is combined with hepatic percutaneous perfusion
    Studie voor patiënten met uitgezaaide oogmelanoom waarbij de behandeling van ipilimumab plus nivolumab wordt gecombineerd met percutane leverperfusie.
    A.3.2Name or abbreviated title of the trial where available
    CHOPIN
    A.4.1Sponsor's protocol code numberNL69508.058.19
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportBristol-Myers Squibb
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportDelcath
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointMedical Oncology
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715263486
    B.5.6E-mailh.w.kapiteijn@lumc.nl
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameNivolumab
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MELPHALAN HYDROCHLORIDE
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Institutional LLC
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMelphalan
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrahepatic use (Noncurrent)
    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 Yes
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameIpilimumab
    D.3.2Product code MDX-010
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.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
    Metastatic uveal melanoma
    Gemetastaseerd oogmelanoom
    E.1.1.1Medical condition in easily understood language
    Metastatic uveal melanoma
    Uitgezaaid oogmelanoom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1: To determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended phase II dose (RPTD) of the combination of ipilimumab plus nivolumab and PHP in patients with unresectable, histologically confirmed metastases of uveal melanoma.
    Phase 2: To determine the efficacy of PHP alone versus the combination of PHP with ipilimumab/nivolumab will be determined in the randomized phase II study.
    Fase 1: Om de veiligheid en verdraagbaarheid, de dosisbeperkende toxiciteiten (DLT’s), maximaal getolereerde dosis te bepalen (MTD) en om de dosis voor het fase II deel van de studie met de combinatie van ipilimumab, nivolumab en PHP vast te stellen. Dit alles voor de behandeling van patienten met niet reseceerbaar, histologisch bewezen metastasen van oogmelanoom.
    Fase 2: De werkzaamheid van alleen PHP versus de combinatie van PHP met ipilimumab en nivolumab zal worden bepaald in het gerandomiseerde fase II deel van deze studie.
    E.2.2Secondary objectives of the trial
    - To evaluate best overall response rate according to RECIST 1.1 and iRECIST of patients treated with PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab.
    - To evaluate overall survival of patients treated with PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab.
    - Het evalueren van het beste algemene responspercentage volgens de RECIST 1.1 en iRECIST criteria bij patienten die alleen met PHP werden behandeld versus patienten die met de combinatie van PHP met ipilimumab en nivolumab werden behandeld.
    - Het evalueren van de algehele overleving van patienten die behandeld zijn met alleen PHP versus patienten die behandeld zijn met de combinatie van PHP met ipilimumab en nivolumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age between 18-70 yrs
    World Health Organization (WHO) Performance Status 0 or I
    50% or less histologically or cytologically confirmed unresectable metastatic uveal melanoma in the parenchyma of the liver
    Hepatic metastases, confined to or predominantly in the liver
    No prior systemic treatment (including chemotherapy, vaccine therapy, monoclonal Ab treatment, IL-2)
    Local pre-treatment of uveal melanoma metastases is allowed (resection and/or thermal ablation), except for chemotherapy containing procedures (e.g. chemoembolization) and radio-embolization, and as long as patients have progressed with measurable disease according to RECIST 1.1
    No concurrent immunosuppressive medications (including dexamethasone, prednisolone, azathioprine)
    Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, Creatinine ≤ 2x ULN, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN
    Women of child bearing potential (WOCBP) must agree to use a reliable form of contraceptive as described in the research protocol
    Men must agree to the use of male contraception as described in the research protocol
    Absence of additional severe and/or uncontrolled concurrent disease
    No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical cancer in situ or adequately treated other cancer with eradicative intent for which the patient has been continuously disease-free for > 2 years.
    No aberrant vascular anatomy of the liver that precludes PHP
    Leeftijd: tussen de 18-70 jaar oud
    WHO-score van 0 of 1
    Histologisch of cytologisch bewezen niet-receseerbaar gemetastaseerd oogmelanoom in de lever, dat niet meer dan 50% beslaat
    Levermetastasen, enkel of met name gelokaliseerd in de lever
    Geen eerdere systemische behandeling ontvangen (waaronder chemotherapie, vaccin therapie, monoclonale antilichamen, IL-2)
    Lokale behandeling van oogmelanoom metastasen is toegestaan (resectie en/of thermische ablatie), met uitzondering van chemotherapie bevattende procedures (chemo-embolisatie) en radio-embolisatie, en zo lang de patiënten sindsdien progressie van ziekte hebben ervaren met meetbare lesies volgens RECIST 1.1
    Geen gelijktijdig gebruik van immunosuppressiva (waaronder dexamethason, prednisolon, azathioprina)
    Bloedwaardes bij screenend onderzoek moeten vallen binnen de volgende grenzen: WBC ≥ 2.0x109/L, Neutrofielen ≥ 1.0x109/L, Plaatjes ≥ 100 x109/L, Hemoglobine ≥ 6.5 mmol/L, Creatinine ≤ 2x ULN, ASAT ≤ 2.5 x ULN, ALAT ≤ 2.5 x ULN, Totaal bilirubine ≤ 1.5 X ULN, INR en PTT in normale range, LDH < 2xULN
    Vrouwen die zwanger kunnen worden moeten akkoord gaan met een betrouwbare vorm van anticonceptie, zoals beschreven in het protocol
    Mannen moeten akkoord gaan met het gebruik van anticonceptie, zoals beschreven in het protocol
    Afwezigheid van bijkomende ernstige en/of ongecontroleerde gelijktijdige ziekte
    Geen eerdere, of nog steeds aanwezige maligniteit, met uitzondering van adequaat behandeld basaal cel carcinoom of plaveiselcelcarcinoom, baarmoederhalskanker in situ of een andere vorm van kanker die adequaat en radicaal is behandeld, waarna de patiënt gedurende >2 jaar onafgebroken ziektevrij is geweest
    Geen afwijkende vasculaire anatomie van de lever, die PHP zou uitsluiten
    E.4Principal exclusion criteria
    Cerebral or meningeal metastasized uveal melanoma
    Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
    Prior immunotherapy (tumor vaccine, cytokine, or growth factor)
    Known history of infection with Human Immunodeficiency Virus;
    Active infection requiring therapy, positive serology for Hepatitis B surface antigen and/or Hepatitis C ribonucleic acid (RNA)
    History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
    History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.
    Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events;
    Latex allergy, and known hypersensitivity/allergy to ipilimumab, nivolumab, melphalan or heparin
    Prior Whipple’s Surgery
    Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
    History of or current immunodeficiency disease, splenectomy or splenic irradiation; prior allogeneic stem cell transplantation
    Patients who are unable to be temporarily removed from chronic anti-coagulation therapy
    Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy
    Use of other investigational drugs before study drug administration for systemic malignancy
    Pregnancy or nursing
    Cerebrale of meningeale metastasen van het oogmelanoom
    Patienten met een actieve autoimmuunziekte of in de voorgeschiedenis vastgestelde autoimmuunziekte, of in het verleden een syndroom dat behandeling met systemische corticosteroiden behoefde. Bovenstaande geldt niet voor patienten met vitiligo of inmiddels verdwenen astma/atopie uit de kindertijd.
    Eerdere behandeling met immuuntherapie (tumor vaccin, cytokines of groeifactor)
    Bekende infectie met HIV nu of in het verleden
    Een infectie die behandeld behoeft, positieve serologie voor Hepatitis B oppervlakte antigenen en/of Hepatitis C RNA
    Voorgeschiedenis van congestief hartfalen, actieve hartaandoeningen, inclusief onstabiel coronair syndroom (instabiele of ernstige angina pectoris, recent myocard infarct). Significante aritmieën en ernstige valvulaire ziekten moeten worden beoordeeld op risico’s van het ondergaan van algehele anesthesie.
    Geschiedenis van of bewezen klinische significantie longziekte, bijvoorbeeld ernstige COPD die het ondergaan van algehele anesthesie uitsluit
    Onderliggende medische aandoeningen die, naar mening van de onderzoeker, de toediening van een onderzoeksbehandeling gevaarlijk maken of de interpretatie van toxiciteit of bijwerkingen onduidelijk maken
    Latexallergie en bekende overgevoeligheid/allergie voor ipilimumab, nivolumab, melfalan of heparine
    Eerdere Whipple operatie
    Gelijktijdige medische aandoening die het gebruik van immunosuppressieve medicatie vereist, of immunosuppressieve dosering van systemische of opneembare topicale corticosteroïden
    Geschiedenis of momenteel aanwezige immunodeficiëntieziekte, splenectomie of bestraling van de milt; eerdere allogene stamceltransplantatie
    Patiënten die niet in staat zijn om tijdelijk te stoppen met hun chronische anticoagulantia therapie
    Patiënten met een actieve bacteriële infectie met systemische manifestaties (malaise, koorts, leukocytose) komen niet in aanmerking totdat de juiste antibacteriële therapie is afgerond
    Gebruik van onderzoeksmedicatie voorafgaand aan deze studie voor de behandeling van een systemische maligniteit
    Zwangerschap of borstvoeding
    E.5 End points
    E.5.1Primary end point(s)
    Safety and feasibility of combining percutaneous hepatic perfusion with ipilimumab and nivolumab (phase 1b part).
    Veiligheid en haalbaarheid van het combineren van percutane leverperfusie met ipilimumab en nivolumab (fase Ib deel)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The phase 1b part of the study will test the safety of the combination of PHP and ipilimumab/nivolumab in a 3+3 design, 3 patients per cohort. The study will consist of 2 dose cohorts of each 3 patients, with an interval of 12 weeks before opening the next dose escalation cohort after the last patient having received the PHP+ipilimumab/nivolumab treatment.
    Het fase Ib deel van het onderzoek zal de veiligheid testen van de combinatie van PHP met ipilimumab en nivolumab in een standard 3+3 model. De studie zal bestaan uit 2 dosiscohorten van elk 3 patiënten, met een interval van 12 weken voorafgaand aan het openen van het volgende dosisescalatiecohort, nadat de laatste patiënt de behandeling met PHP en ipililumab en nivolumab heeft ontvangen.
    E.5.2Secondary end point(s)
    Description of response rate and OS.
    Evaluation of baseline biomarkers for outcome (RR and PFS) upon PHP+IPI+NIVO (Cancer Immunogram parameters, IFN-signature, Batf3 signature, T cell inflamed signature, tumor educated platelets, serum parameters).
    Evaluation of changes of immune-infiltrates (IHC, DSP, RNAseq, TCRseq) comparing baseline, week 6, week 12, and biopsies taken at progression.
    Characterization of PBMC (FACS, TCRseq, single cell sequencing) comparing baseline, week 6, week 12, and biopsies taken at progression.
    Beschrijving van het responspercentage en de algehele overleving.
    Evaluatie van baseline biomarkers voor uitkomst (responspercentage en progressie vrije overleving) na behandeling met PHP, ipililumab en nivolumab.
    Evaluatie van veranderingen in het immuuninfiltraat vergeleken met baseline, na week 6, week 12 en in de biopten die worden afgenomen bij progressie
    Karakterisering van PBMC (FACS, TCRseq, sequentiebepaling van afzonderlijke cellen) waarbij baseline, week 6, week 12 en biopten die worden afgenomen bij progressie met elkaar worden vergeleken
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the definition of the MTD further patient inclusion will be in the randomized phase II part of the study. Randomization on a 1:1 basis will take place in the phase II part between PHP versus PHP plus ipilimumab/nivolumab. Description of PFS according to RECIST 1.1. will be evaluated at one year in the PHP-group versus PHP plus ipilimumab/nivolumab group.
    Na het vaststellen van de maximaal tolereerbare dosis in fase Ib zal verder worden gegaan met het gerandomiseerde fase II deel van de studie. Randomisatie vindt plaats op 1:1 basis tussen PHP versus PHP met ipilimumab en nivolumab. Beschrijving van progressie vrije overleving volgens RECIST 1.1 zal plaatsvinden na 1 jaar, om daarmee de PHP groep met de PHP plus ipilimumab en nivolumab groep met elkaar te vergelijken.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase Ib/II study
    Fase Ib/II studie
    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 Yes
    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.8.2.4Number 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 concerned2
    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 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
    LVLS
    Laatste bezoek van de laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state88
    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)
    The patients that have ended participation in the trial will be treated according to standard treatment for their condition.
    Patiënten zullen na beëindiging van hun deelname aan de studie worden volgens het standaard protocol voor hun aandoening worden behandeld.
    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 Decision2020-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-28
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA