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    Summary
    EudraCT Number:2012-003123-38
    Sponsor's Protocol Code Number:RPC01-202
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-003123-38
    A.3Full title of the trial
    A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
    A.4.1Sponsor's protocol code numberRPC01-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01647516
    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 SponsorCelgene International II Sàrl (CIS II)
    B.1.3.4CountrySwitzerland
    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 supportCelgene International II Sàrl (CIS II)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointPPD Project Manager
    B.5.3 Address:
    B.5.3.1Street Address929 North Front Street
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeNC 28401-3331
    B.5.3.4CountryUnited States
    B.5.4Telephone number1910558 6748
    B.5.5Fax number1910558 6748
    B.5.6E-mailMartine.Oehling@ppdi.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 name0.25 mg RPC1063
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRPC1063
    D.3.9.2Current sponsor codeRPC1063
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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: 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 name0.5 mg RPC1063
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRPC1063
    D.3.9.2Current sponsor codeRPC1063
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 name1 mg RPC1063
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRPC1063
    D.3.9.2Current sponsor codeRPC1063
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral 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 Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the efficacy of RPC1063 vs placebo for induction of clinical remission at Week 8 in patients with moderately to severely active UC.
    E.2.2Secondary objectives of the trial
    - Compare the efficacy of RPC1063 vs placebo at weeks 8 and 32 as measured by clinical response, clinical remission, and mucosal healing
    - Compare the overall safety and tolerability of RPC1063 vs placebo for the duration of the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or female patients aged 18 to 75 years, inclusive
    2. Have had UC diagnosed at least 2 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence
    3. Have active UC confirmed on endoscopy with ≥ 15 cm involvement
    4. Have active UC defined as Mayo score of 6-12 inclusive with endoscopic subscore of ≥ 2
    5. Have undergone colonoscopy or sigmoidoscopy within the past 2 years for extent of disease, and if the UC has been present for > 10 years, have had a colonoscopy with biopsy to rule out dysplasia
    6. Female patients of childbearing potential:
    Must agree to practice a highly effective method of contraception of the 75-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in
    combination result in a failure rate of a Pearl index of less than 1% per
    year when used consistently and correctly. Acceptable methods of birth
    control in the trial are the following:
    - Combined hormonal (oestrogen and progestogen containing)
    contraception, which may be oral, intravaginal, or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of
    ovulation, which may be oral, injectable, or implantable
    - Placement of an intrauterine device (IUD)
    - Placement of an intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion
    - Vasectomised partner
    - Sexual abstinence
    Male patients:
    Must agree to use a latex condom during sexual contact with women of
    childbearing potential while participating in the study until completion of
    the 75-day Safety Follow-up Visit.
    All patients:
    Periodic abstinence (calendar, symptothermal, post-ovulation methods),
    withdrawal (coitus interruptus), spermicides only, and lactational
    amenorrhoea method are not acceptable methods of contraception.
    Female condom and male condom should not be used
    7. Must be currently receiving treatment with at least 1 of the following therapies:
    a. Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) for at least 6 weeks with the dose stable for at least 3 weeks prior to screening endoscopy
    b. Prednisone (doses ≤ 30 mg) or equivalent for at least 4 weeks and receiving a stable dose for at least 2 weeks
    8. If oral aminosalicylates or corticosteroids have been recently discontinued, they must have been stopped for at least 2 weeks prior to the endoscopy used for baseline Mayo Score
    9. All patients aged 45 years or over must have had a colonoscopy to screen for adenomatous polyps within 5 years of their first dose of investigational drug or must have had a colonoscopy at screening to assess for polyps. The adenomatous polyps must be removed prior to their first dose of investigational drug.
    10. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
    11. Patients must have documentation of positive Varicella Zoster virus (VZV) IgG antibody status or complete VZV vaccination at least 30days prior to randomization.
    12. Documentation of no evidence of chronic lung disease or tuberculosis (TB) on a chest X-ray completed within the 6 months prior to screening. If a chest X-ray was not done in the 6 months preceeding the Screening visit, it may be performed during the Screening visit
    E.4Principal exclusion criteria
    1. Have severe extensive colitis evidenced by:
    - Physician judgment that patient is likely to require colectomy or
    ileostomy within 12 weeks of baseline
    - Current evidence of fulminant colitis,toxic megacolon or bowel
    perforation
    - Previous total colectomy
    - Have 4 or more of the following:
    Temp > 38°C, Heart rate (HR) > 110 (bpm);Focal severe or rebound
    abdominal tenderness;Anemia (hemoglobin [Hgb] < 8.5 g/dL);
    Transverse colon diameter > 5cm on plain X-ray
    2. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
    3. Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested
    4. Have had treatment with cyclosporine, tacrolimus, sirolimus, or
    mycophenolate mofetil (MMF) within 16 weeks of screening
    5. Pregnancy, lactation, or a positive serum beta human chorionic
    gonadotrophin (hCG) measured during screening
    6. Clinically relevant hepatic, neurological, pulmonary,ophthalmological,endocrine, psychiatric or other major systemic disease making implementation or interpretation of the study difficult or that would put the patient at risk
    7. Clinically relevant cardiovascular conditions, including history or
    presence of:
    i. Recent (within the last 6 months) occurrence of myocardial infarction,
    unstable angina, stroke, transient ischemic attack, decompensated heart
    failure requiring hospitalization, Class III/IV heart failure, sick sinus
    syndrome, or severe untreated sleep apnea
    ii. Prolonged QTcF interval (QTcF > 450 msec males, > 470 msec
    females), or at additional risk for QT prolongation (e.g., hypokalemia,
    hypomagnesemia, congenital long-QT syndrome, concurrent therapy
    with QT prolonging drugs)
    iii. Patients with other pre-existing stable cardiac conditions who have
    not been cleared for the study by an appropriate cardiac evaluation by a
    cardiologist
    8. Resting HR less than 55 beats per minute (bpm)
    9. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus
    type 2 with hemoglobin A1c > 7%, or diabetic patients with significant
    co-morbid conditions such as retinopathy or nephropathy
    10. History of uveitis
    11. Known active bacterial, viral, fungal, mycobacterial infection or other infection (including TB or atypical mycobacterial disease [excluding fungal infection of nail beds]) or any major episode of infection that required hospitalization/treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening
    12. History of recurrent or chronic infection (e.g., hepatitis B or C,
    human immunodeficiency virus, syphilis, TB); recurring urinary tract
    infections are allowed
    13. History of cancer, including solid tumors and hematological
    malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved)
    14. History of alcohol or drug abuse within 1 year prior to randomization
    15. History of or currently active primary or secondary immunodeficiency
    16. History of failure to respond to an anti-integrin agent prior to randomization.
    17. History of treatment with a biologic agent within 5 half-lives of that agent prior to randomization.
    18. History of treatment with topical rectal steroids within 2 weeks of screening
    19. Receipt of a live vaccine or attenuated live vaccine within 4 weeks prior to randomization
    20. Previous treatment with lymphocyte-depleting therapies (e.g.,
    Campath,anti-CD4, cladribine, rituximab, ocrelizumab,
    cyclophosphamide, mitoxantrone, total body irradiation,bone marrow
    transplantation, alemtuzumab, daclizumab)
    21. Previous treatment with D-penicillamine,leflunomide or thalidomide
    22. Previous treatment with natalizumab or fingolimod)
    23. History of treatment with IVIg,plasmapheresis,within 3 months
    prior to randomization
    24. Planned concurrent treatment with immunosuppressive agents (e.g., azathioprine, 6-MP, or methotrexate) after randomization. Subjects receiving azathioprine, 6-MP or methotraxate at screening must discontinue treatment with these agents prior to dosing with investigational drug.
    25. Treatment with Class Ia or Class III anti-arrhythmic drugs. QT
    prolonging drugs with a known risk of torsades de pointes (e.g,
    citalopram, chlorpromazine, haloperidol, methadone, and erythromycin),
    or treatment with two or more agents in combination known to prolong
    PR interval
    26. Treatment with any of the following drugs or interventions within the corresponding timeframe:
    - At randomization: CYP2C8 inhibitors (eg, gemfibrozil or clopidgrel) or inducers (eg, rifampicin)
    - Two weeks prior to randomization: Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
    (Please refer to the protocol for the remaining criteria)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in clinical remission, defined as a Mayo score of ≤ 2 points and with no individual subscore of > 1 point
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    Efficacy Endpoints:

    • Proportion of patients with a clinical response at Week 8, defined as a reduction from baseline in Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
    • Change from baseline in Mayo score at Week 8
    • Proportion of patients with mucosal healing at Week 8, defined by an endoscopy subscore of ≤ 1 point
    Proportion of patients in clinical remission at Week 32 defined as Mayo score of ≤ 2 points with no individual subscore of > 1 point
    • Proportion of patients with a clinical response at Week 32, defined as a reduction from baseline in Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
    • Proportion of patients with mucosal healing at Week 32, defined by an endoscopy subscore of ≤ 1 point

    Safety Endpoints:

    • The incidence and type of AEs, SAEs, AEs leading to discontinuation of study treatment, target AEs of special interest, laboratory abnormalities, vital signs, ECG, and physical exam abnormalities

    PK and PD Endpoints:

    • PK assessments will include PK sampling to determine plasma concentration of RPC1063 and active metabolites at scheduled assessments during the treatment period (see Table 1 [IP and MP] and Table 2 [OLP] Schedule of Events)
    • Absolute lymphocyte count (ALC) derived from blinded hematology laboratory results
    • Plasma protein biomarkers (cytokines, chemokines, other inflammatory proteins)
    • Stool analysis for fecal biomarkers – fecal lactoferrin and calprotectin
    • Total immunoglobulins (Igs) - IgA, IgG, IgM
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Optional open-label treatment period
    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 trial3
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Belgium
    Bulgaria
    Greece
    Hungary
    Israel
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Slovakia
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 86
    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)
    Standard of care
    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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-30
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