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    Summary
    EudraCT Number:2014-001295-65
    Sponsor's Protocol Code Number:TXC-CD-002-2011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-11-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001295-65
    A.3Full title of the trial
    A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, multi-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease
    A.3.2Name or abbreviated title of the trial where available
    CATS29
    A.4.1Sponsor's protocol code numberTXC-CD-002-2011
    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 SponsorTxCell
    B.1.3.4CountryFrance
    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 supportTxCell
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTxCell
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressAllée de la Nertière - Les Cardoulines
    B.5.3.2Town/ cityValbonne - Sophia-Antipolis
    B.5.3.3Post code06560
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0) 497 218 301
    B.5.5Fax number+33(0) 493 641 580
    B.5.6E-mailclinical@txcell.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOvasave
    D.3.4Pharmaceutical form Suspension for injection
    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 INNOva-Treg
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeOva-Treg
    D.3.9.3Other descriptive nameAutologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10e4
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberOvasave classified as "somatic cel therapy medicinal product", "not combined". Reference: EMA/CAT/765386/2009 (scientific recommendation) and EMA/CAT/38247/2010 (letter)
    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 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 nameOvasave
    D.3.4Pharmaceutical form Suspension for injection
    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 INNOva-Treg
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeOva-Treg
    D.3.9.3Other descriptive nameAutologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10e6
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberOvasave classified as "somatic cel therapy medicinal product", "not combined". Reference: EMA/CAT/765386/2009 (scientific recommendation) and EMA/CAT/38247/2010 (letter)
    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 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 nameOvasave
    D.3.4Pharmaceutical form Suspension for injection
    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 INNOva-Treg
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeOva-Treg
    D.3.9.3Other descriptive nameAutologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10e7
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberOvasave classified as "somatic cel therapy medicinal product", "not combined". Reference: EMA/CAT/765386/2009 (scientific recommendation) and EMA/CAT/38247/2010 (letter)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to severely active Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Moderately to severely active Crohn's Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Controlled versus placebo confirmation of the ability of a single intravenous (i.v.) injection of 1.10^6 cells dose of Ovasave (Ova-Treg cells) to induce a CDAI response (CDAI decrease ≥ 100 points) 6 weeks post administration compared to placebo.
    E.2.2Secondary objectives of the trial
    - Safety assessment of a first and second i.v. injection of Ovasave (CATS29-DB) and of a 3rd and 4th i.v. injection of Ovasave (CATS29-OL).
    - Assessment of different doses (placebo, 1.10^4, 1.10^6 and 1.10^7 cells) and comparison of the efficacy and the safety between doses.
    - Assessment of the safety and efficacy (response and remission) of a second injection of 1.10^6 cells at Week 8.
    - Reduction of steroids treatment of different doses (placebo, 1.10^4, 1.10^6 and 1.10^7 cells) at week 14.
    - Assesment of safety during the 3-year long-term follow-up after first dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At the screening visit (V1):

    1) Willing and able to provide written informed consent (IC);
    2) Male or Female aged between 18 and 70 (inclusive) years of age;
    3) Crohn's Disease diagnosis defined as patients with medical history of signs, symptoms and biological evidence of active bowel inflammation: Documented endoscopic evidence of Crohn's diagnosis at least 1 year prior to V1 (an endoscopy will be perform if the one available has more than 1 year at V1);
    4) Elevated High sensitive C-reactive protein (hs-CRP) > 10 mg/L at V1;
    5) Calprotectin ≥ 250 μg/g;
    6) Failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologic; and had not responded (primarily failure) or responded and then lost response completely (no response or need to increase the dose / secondary failure) or were intolerant to this therapy at a dose indicated for CD (Refer to Appendix 17.6 for the definition of refractoriness);
    7) Documented CDAI (Crohn's Disease Activity Index) ≥ 250 at V1 or within the past 3 months prior to V1;
    8) Total white cell count ≥ 4.0.10^9 / L;
    9) Platelets between 150.10^9 and 600.10^9 / L (included);
    10) Hemoglobin > 8.5 g/dL;
    11) Full blood count (FBC) and biochemistry without any clinically significant abnormalities except if CD-related, at Investigator's discretion;
    12) Normal, or no clinically significant abnormality in the electrocardiogram (ECG) at Investigator's discretion;
    13) Patients willing and able to observe an intake of ovalbumin through the ingestion of a meringue daily after the first administration until the end of the Double-blind phase and during the OL-phase if the patient receives additional administration;

    At the Visit 3 (week-4):

    1) CDAI ≥ 250;
    2) Evidence of inflammation by an elevated hs-CRP value (> 5 mg/L) OR endoscopic / MRI evidence of local intestinal inflammation, OR elevated calprotectin (≥ 250μg/g) to be confirmed before V4 (first administration);

    Between visit 8 (week14) and visit 9 (week16):

    1) Upon Investigator recommendation, patient qualification will be based on acceptable safety and tolerability profile of the IMP before continuing to receive intravenous administrations of Ovasave at a dose of 10^6 cells.
    E.4Principal exclusion criteria
    1) Current or recent history (12 preceding months before V1) of major organ or system failure or condition, acute or chronic that in the opinion of the Investigator should preclude enrolment, except Crohn’s Disease;
    2) Current or previous history of malignancy except a local basal cell carcinoma without metastases;
    3) First degree family or personal history of clinically significant venous, arterial or pulmonary thromboembolism events;
    4) History of thrombocytosis over 600.10^9 / L in the previous 12 months prior to V1;
    5) History of major immune deficiency disorder, except Crohn’s Disease;
    6) Concomitant clinically active infection at V1 or V2 or V3 or V4 or V7 or V9 CATS29-OL or V11 CATS29-OL;
    7) History of intestinal resection or intra-abdominal surgery within 6 months prior to V1;
    8) Have complication of Crohn’s Disease such as strictures, stenosis, short gut syndrome, or any other manifestation that might require surgery, could preclude the use of CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with Ovasave;
    9) Patients with intestinal functional fibrotic structuring responsible for the patient’s symptoms or previous major Gastro Intestinal (GI) resection;
    10) Patients with short bowel syndrome or with less than 1.5 m of small bowel;
    11) Presence of actively draining fistula at V3 or V4;
    12) Concomitant abdominal or anal undrained abscess at V3 or V4;
    13) History of documented hypersensitivity or intolerance to chicken eggs;
    14) Parenteral nutrition if not compatible with the meringue intake;
    15) History of known hypersensitivity or intolerance to any component of the IMP (Refer to Appendix 17.7 of the Protocol for the composition of the Drug Product);
    16) Patients with ileostomia or colostomy;
    17) History of tuberculosis (TB) except if documentation of adequate compliance to treatment is provided,
    18) Gamma immunoglobulinaemia < 6 g/L at Screening visit (V1) or Pre-entry visit (V3) or any signs or history of major immune deficiency disorder;
    19) Recent history of contamination by the Epstein-Barr virus (EBV), Cytomegalovirus (CMV) and/or toxoplasma within 6 months prior to V1;
    20) History of human immunodeficiency virus (HIV);
    21) Females of childbearing potential who are either pregnant, breast-feeding or without the use of birth control. Female patients of child-bearing potential must have a negative pregnancy test at screening and must agree to use an acceptable method of birth control with a low failure rate (i.e. less than 1% per year) in a consistent and correct manner for the whole duration of the study treatment period and during the 3 months following the end of the study treatment period (V13/week 32). Abstinence, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, a contraceptive vaginal ring (e.g. NuvaRing or equivalent) or a contraceptive transdermal patch (e.g. EVRA or equivalent) administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly or a subcutaneous implant of etonogestrel (Implanon or equivalent) for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral ovariectomy.
    22) A history of poor clinic attendance or, in the opinion of the Investigator, is considered unlikely to comply with the required visit schedule and other protocol requirements.
    23) Use of any experimental medicinal product within the 3 months prior to Screening, or during the study, except Ovasave and any experimental medicinal product up to the end of the 3-year long-term safety followup.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical efficacy endpoint is the percentage of patients with a CDAI response (CDAI decrease from baseline ≥ 100 points) in the active group of 10^6 Ova-Treg cells, 6 weeks after 1 Ovasave administration (Week 6= V6) compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 Weeks after 1 Ovasave administration
    E.5.2Secondary end point(s)
    - CDAI:

    • Percentage of patients with a CDAI remission and response (CDAI decrease from baseline ≥ 100 points) 6 weeks after the second administration (week 14) for the 4 groups,
    • Percentage of patients with a CDAI response at each other post-baseline visit for the 4 groups,
    • Percentage of patients achieving a CDAI remission (CDAI < 150 points) at each post-baseline visit,
    • Raw value in CDAI total score at each post-baseline visit for the 4 groups
    • Raw value in each CDAI sub-score at each post-baseline visit for the 4 groups
    • Change from baseline in CDAI total score at each post-baseline visit for the 4 groups

    - Steroids sparing effect

    • Steroid decrease from week 8 will be recorded at week 14 (including the daily dose taken at each week between visit 7 and visit 8)
    • Percentage of patient by decrease steroids dose (decrease in total of 20, 15, 10, 5 or 0 mg/day) at week 14.

    - Inflammatory markers:

    • Raw value in hs-CRP at each post-baseline visit;
    • Change from baseline in hs-CRP at each post-baseline visit;
    • Raw value in Calprotectin at each post-baseline visit;
    • Change from baseline in Calprotectin at each post-baseline visit

    - Investigator’s opinion on the investigational product

    • Qualify the investigational product
    • Would you like to test the investigational product again?
    E.5.2.1Timepoint(s) of evaluation of this end point
    - CDAI:

    • At week 14
    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit

    • Steroids sparing effect:

    • At week 14
    • At week 14

    - Inflammatory markers:

    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit
    • At each post-baseline visit

    - Investigator’s opinion on the investigational product:

    • At weeks 16 and 32
    • At weeks 16 and 32
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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