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    Summary
    EudraCT Number:2016-000227-71
    Sponsor's Protocol Code Number:ITCC-059
    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:2016-04-28
    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 number2016-000227-71
    A.3Full title of the trial
    A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The safety and efficacy of the medicine Inotuzumab Ozogamicin in children with relapsed/refractory acute lymphatic leukemia (ALL)
    A.3.2Name or abbreviated title of the trial where available
    ITCC-059
    A.4.1Sponsor's protocol code numberITCC-059
    A.5.4Other Identifiers
    Name:NTRNumber:NTR5736
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/304/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorErasmus 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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrincess Maxima Center
    B.5.2Functional name of contact pointTrial and Datacenter
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 25
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CS
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+316 5280 31 32
    B.5.5Fax number+3188 972 9009
    B.5.6E-mailtrialmanagement@prinsesmaximacentrum.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.2.1.1.1Trade name BESPONSA
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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/3/13/1127
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder 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 INNBesponsa
    D.3.9.1CAS number 635715-01-4
    D.3.9.3Other descriptive nameINOTUZUMAB OZOGAMICIN
    D.3.9.4EV Substance CodeSUB33081
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.2 to 1.0
    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) 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
    pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia
    E.1.1.1Medical condition in easily understood language
    Pediatric relapsed Acute Lymphoblastic Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10063625
    E.1.2Term Acute lymphoblastic leukemia recurrent
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective Stratum 1A:
    To establish the maximum tolerated dose of single agent InO when administered in children with CD22-positive relapsed/refractory BCP-ALL.

    Primary objective Phase 2 Cohort:
    To establish the activity (ORR) of single agent InO when administered in children with CD22-positive relapsed/refractory BCP-ALL.

    Primary objective Stratum 2: To explore the safety and tolerability of InO as a single agent in children with relapsed/refractory other CD22 positive B-cell malignancies.
    E.2.2Secondary objectives of the trial
    Stratum 1A and Phase 2 cohort:
    To determine:
    •safety and tolerability of InO as a single agent (during course 1, cumulative toxicity, and after subsequent allo-HSCT).
    •hematological response rate (Stratum 1A only)
    •MRD levels in responding patients, % of patients with complete MRD.
    •durability of response and long-term FUP (relapse-rates, HSCT-nrs, overall survival).
    •serum PK parameters
    •the relationship between CD22 receptor density, WBC-Count at start of treatment, CD22 saturation kinetics, cytogenetics, and in-vitro calicheamicin resistance to clinical response.
    •persistence of B-Cell aplasia and hypogammaglobulinemia in responding patients.
    •nr of patients developing ADAs

    Stratum 2 (Other B-cell malignancies):
    to determine
    •response rates
    •durability of response and long-term FUP (SCT-nrs, relapse, overall survival)
    •serum PK parameters
    •persistence of B-Cell aplasia and hypogammaglobulinemia in responding patients
    •nr of patients developing ADA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age:
    Patients must be ≥ 1 and < 18 years of age at the time of enrollment.
    •The first 3 BCP-ALL patients on dose level 1 must be aged 6-18 yrs.
    •Then at least 2 additional patients must be enrolled from age 1-6 yrs at the same dose level.
    •After this: subsequent dose levels may enroll patients aged 1-18 yrs.
    •In case 2 younger patients are not yet recruited, patients aged 6-18yrs may continue to be enrolled at dose level 1 until a maximum of 6 patients are enrolled.

    Stratum 1A: Diagnosis
    Patients must have either first relapsed BCP-ALL after allo-HSCT or second or greater relapsed or refractory BCP-ALL, or refractory disease and must meet the following criteria:
    •M2 or M3 marrow status (≥ 5% blasts by morphology)
    •CD22 surface antigen positive (either BM or PB)
    •The first 6 patients must have M3 marrow status (≥ 25% blasts by morphology).
    •Refractory is defined as newly diagnosed patients who are induction failures after at least 2 previous regimens without attainment of remission, or patients with refractory first relapse after 1 previous reinduction regimen without attainment of remission.

    Phase 2 Cohort: Diagnosis
    Patients must have either first relapsed BCP-ALL after allo-HSCT or second or greater relapsed or refractory BCP-ALL, or refractory disease as defined below, and must meet the following criteria:
    •M2 or M3 marrow status (≥ 5% blasts by morphology)
    •CD22 surface antigen positive (either BM or PB)
    •Refractory is defined as newly diagnosed patients who are induction failures after at least 2 previous regimens without attainment of remission, or patients with refractory first relapse after 1 previous reinduction regimen without attainment of remission.

    Stratum 2: Diagnosis
    Patients must have first relapsed BCP-ALL after allo-HSCT or second or greater relapsed or refractory CD22-positive B-cell malignancy including but not limited to diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), Burkitt lymphoma, Burkitt leukemia or B-cell precursor lymphoblastic lymphoma:
    • histologic verification of disease at original diagnosis or subsequent relapse.
    •Patient must have evaluable or measurable disease documented by radiographic criteria or bone marrow disease present at study entry.
    • CD22 surface antigen positive (in either biopsy material, BM or PB)

    Performance Level and Life Expectancy:
    •Karnofsky > 60% for patients > 16 years of age and Lansky > 60% for patients ≤ 16 years of age.
    •life expectancy of at least 6 weeks.

    Prior Therapy:
    Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy defined as resolution of all such non-hematologic toxicities to ≤ Grade 2 per the CTCAE 4.03.
    •Chemotherapy: At least 7 days wash-out; except for hydroxyurea, 6-mp and steroids (wash-out 48 hrs) and intrathecal therapy (no wash-out). Patients who relapse while receiving maintenance chemotherapy will not be required to have a waiting period.
    •Radiotherapy: At least 28 days must have elapsed since any prior radiation therapy.
    •Hematopoietic Stem Cell Transplant: At least 90 days must have elapsed since previous allo-HSCT. No evidence of active GVHD; not receiving GVHD prophylaxis or treatment.
    •Hematopoietic growth factors: At least 7 days wash-out of therapy with GCSF or other growth factors. At least 14 days wash-out of pegfilgrastim (Neulasta®).
    •Immunotherapy: At least 42 days wash-out of any type of immunotherapy, e.g. CART therapy. No prior CD22-targeted therapy or tumor vaccines permitted.
    •Monoclonal antibodies: wash-out of at least 3 half-lives of the antibody (ie: Rituximab = 66 days, Epratuzumab = 69 days), with the exclusion of blinatumomab. Patients must have been off blinatumomab infusion for at least 14 days and all drug-related toxicity must have resolved to grade 2 or lower.
    •Investigational drugs: At least 7 days or 5 drug half-lives (whichever is longer) must have elapsed since prior treatment with any experimental drug (with the exception of monoclonal antibodies).
    •no prior treatment with a calicheamicin-conjugated antibody (e.g. gemtuzumab ozogamicin).
    Renal and Hepatic Function:
    •serum creatinine ≤ 1.5 x ULN according to age. If the serum creatinine is > than 1.5 xULN, the patient must have a radioisotope GFR ≥ 70mL/min/1.73m2.
    •AST and ALT ≤ 2.5 x ULN.
    •total bilirubin ≤ 1.5 x ULN (unless patient has documented Gilbert syndrome &AST and ALT are <=2.5 x ULN).
    Cardiac Function:
    •shortening fraction ≥ 30% by ECG or an ejection fraction > 50% by MUGA.
    Reproductive Function:
    •If applicable, negative urine or serum pregnancy test confirmed prior to enrollment.
    •If applicable, agree not to breastfeed while on this study.
    •If applicable, agree using effective method of contraception during the study and for 90 days after the last dose of InO.
    E.4Principal exclusion criteria
    Isolated extramedullary relapse:
    •Patients with isolated extramedullary disease are excluded (not applicable to lymphoma patients except for isolated CNS-relapse)

    VOD/SOS:
    •Patients with any history of prior or ongoing VOD/SOS per the modified Seattle criteria are excluded, as specified in appendix 3, or prior liver-failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)].

    Infection:
    Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient may not have:
    •A requirement for vasopressors;
    •Positive blood culture within 48 hours of study enrollment;
    •Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.
    •A positive fungal culture within 30 days of study enrollment.
    •Active fungal, viral, bacterial, or protozoal infection requiring IV or oral treatment. Chronic prophylaxis therapy to prevent infections is allowed.

    Other anti-cancer therapy:
    •Patients will be excluded if there is a plan to administer non-protocol anti-cancer therapy including but not limited to chemotherapy, radiation therapy, or immunotherapy during the study period.

    Allergic reaction:
    •Patients with prior Grade 3/4 allergic reaction to a monoclonal antibody are excluded.

    Concurrent disease:
    •Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, interfere with consent, study participation, follow up, or interpretation of study results.
    •Patients with Down syndrome are excluded for the phase 1 dose finding part (stratum 1A), but not in the stratum 1 phase 2 cohort.

    E.5 End points
    E.5.1Primary end point(s)
    Stratum 1A:
    Dose-limiting toxicities (DLTs) during the first course of therapy.

    Phase 2 cohort:
    Overall Response Rate (ORR), defined as CR, CRi, CRp, measured as best response during InO treatment (see Appendix 2 for definitions).

    Stratum 2: Safety and tolerability:
    • AEs, as characterized by type, frequency, severity (as graded using CTCAE version, v4.03), timing, seriousness, and relation to study therapy, during the first and subsequent courses of therapy.
    • Occurrence of toxic death; i.e., death attributable to InO therapy.
    • Occurrence of hepatic VOD/SOS during or after therapy with InO.
    • Laboratory abnormalities as characterized by type, frequency, severity and timing.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After course 1
    E.5.2Secondary end point(s)
    Stratum 1A:
    1. Safety and tolerability:
    • AEs (type, frequency, severity, timing, seriousness, and relation to study therapy.
    • Occurrence of toxic death
    • Occurrence of hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) during or after therapy with InO.
    • Laboratory abnormalities (type, frequency, severity and timing).
    2. Measures of anti-leukemic activity:
    • Overall Response Rate (ORR), defined as CR, CRi, CRp , best response over multiple courses
    • MRD levels, incl. % of patients who become MRD-negative (defined as an MRD-level < 1x10-4), after course 1, as well as the best response (MRD-negativity) over multiple courses.
    • Duration of response (time between achieving response (CR, CRi or CRp) after starting study treatment and documented relapse or death).
    • Number and percentage of patients being transplanted after treatment with Ino.
    • Event-free survival (EFS), defined as the time between start of study treatment and first event including failure to achieve CR/CRp/CRi (calculated as an event on day 0), relapse, death of any cause and second malignancies.
    • Overall survival, defined as time to death following start of study treatment.
    3. Serum pharmacokinetic parameters of InO and unconjugated calicheamicin.
    4. Pharmacodynamic parameters:
    • Relationship between response (ORR) and CD22 expression levels, WBC, CD22 saturation kinetic, calicheamicin sensitivity.
    • Clonal evolution (CD22-negativity) and relation to loss of response.
    5. Other endpoints
    • % of patients responding to InO (ORR) without adequate recovery of CD19-positive B-cells or immunoglobulins following 4 wks, 10 wks, 3, 6 and 12 mnths after treatment (excl. HSCT patients).
    • % of patients with anti-drug antibodies (ADA).

    Phase 2 cohort:
    Safety:
    • AEs (type, frequency, severity, timing, seriousness, and relation to study therapy)
    • Occurrence of toxic death
    • Occurrence of VOD/SOS during or after therapy with InO.
    • Laboratory abnormalities (type, frequency, severity and timing).

    2. Other measures of anti-leukemic activity:
    • Overall Response Rate (ORR) after course 1.
    • Minimal residual disease levels, including the percentage of patients who become MRD-negative , after course 1, as well as the best response (MRD-negativity) over multiple courses.
    • Duration of response (time between achieving response (CR, CRi or CRp) after starting study treatment and documented relapse or death).
    • Number and percentage of patients being transplanted after treatment with Ino.
    • Event-free survival (EFS), defined as the time between start of study treatment and first event including failure to achieve CR/CRp/CRi (calculated as an event on day 0), relapse, death of any cause and second malignancies.
    • Survival, defined as time to death following start of study treatment.
    3. Serum pharmacokinetic parameters of InO and unconjugated calicheamicin.
    4. Pharmacodynamic parameters:
    • Relationship between response (ORR) and CD22 expression levels, WBC, CD22 saturation kinetics and calicheamicin sensitivity.
    • Clonal evolution (CD22-negativity) and relation to loss of response.
    5. Other endpoints
    • The percentage of patients responding to InO (ORR) without adequate recovery of CD19-positive B-cells or immunoglobulins following 4 wks, 10 wks, 3, 6 and 12 months after treatment with InO, (excl. HSCT patients from HSCT date)
    • Percentage of patients who exhibit ADA.

    Stratum 2 secondary endpoints:
    1. Measures of anti-tumor activity:
    • Overall remission rate (CR and PR) both after course 1 as well as overall best response in patients receiving multiple courses of InO therapy (see Appendix 2 for definitions).
    • Duration of response (time between achieving response (CR and PR) after starting study treatment and documented relapse or death).
    • Number and percentage of patients being transplanted after treatment with Ino.
    • Event-free survival (EFS), defined as the time between start of study treatment and first event including failure to achieve CR/PR (calculated as an event on day 0), relapse, death of any cause and second malignancies.
    • Overall survival, defined as time to death following start of study treatment.
    2. Serum pharmacokinetic parameters of InO and unconjugated calicheamicin.
    3. Other endpoints:
    • The percentage of patients responding to InO (ORR) without adequate recovery of CD19-positive B-cells or immunoglobulins following 4 wks, 10 wks, 3, 6 and 12 mths after treatment, (excl HSCT patients from HSCT date).
    • Percentage of patients who exhibit ADA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After course 1, after each subsequent course of therapy, and at 4wks, 10wks, 3months, 6 months and 9 months of FUP
    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 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
    First administration in pediatric population
    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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Austria
    Czech Republic
    Denmark
    France
    Germany
    Ireland
    Israel
    Italy
    Netherlands
    Spain
    Sweden
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 111
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 67
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 32
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 111
    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
    G.4.1Name of Organisation ITCC
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-02
    P. End of Trial
    P.End of Trial StatusOngoing
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