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    Summary
    EudraCT Number:2014-001345-24
    Sponsor's Protocol Code Number:B1371012
    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:2015-01-26
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-001345-24
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND PHASE 1B/2 STUDY OF PF-04449913 IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH PREVIOUSLY UNTREATED INTERMEDIATE-2 OR HIGH-RISK MYELODYSPLASTIC SYNDROME, ACUTE MYELOID LEUKEMIA WITH 20-30% BLASTS AND MULTI-LINEAGE DYSPLASIA, OR CHRONIC MYELOMONOCYTIC LEUKEMIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test the safety and efficacy of PF-04449913 with azacitidine versus placebo with azacitidine in patients with Intermediate-2 or high risk myelodysplastic syndrome, acute myeloid leukemia with 20-30% blasts and multi-lineage dysplasia, or chronic myelomonocytic.
    A.4.1Sponsor's protocol code numberB1371012
    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 SponsorPfizer Inc. 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+0018007181021
    B.5.5Fax number+0013037391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-04449913
    D.3.2Product code PF-04449913
    D.3.4Pharmaceutical form Tablet
    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 INNN/A
    D.3.9.2Current sponsor codeB1371012
    D.3.9.3Other descriptive namePF-04449913
    D.3.9.4EV Substance CodeSUB31245
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    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 Yes
    D.2.1.1.1Trade name Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVidaza
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Intermediate-2, High-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia with 20-30% Blasts and Multi-Lineage Dysplasia, or Chronic Myelomonocytic Leukemia.
    E.1.1.1Medical condition in easily understood language
    A bone marrow disorder that disrupts a body's normal production of blood cells
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10028537
    E.1.2Term Myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives for the Phase 1b (Safety Lead-In)
    •To assess the safety and tolerability of PF 04449913 when administered in combination with azacitidine in patients with previously untreated Intermediate-2 or High-Risk MDS, AML with 20%-30% blasts and multi-lineage dysplasia or CMML.

    Primary Objectives for the Randomized Phase 2 Component
    •To demonstrate superior response rate (RR) of azacitidine and PF-04449913 versus azacitidine and placebo in the treatment of patients with previously untreated Intermediate-2 or High-Risk MDS, AML with 20-30% blasts and multi-lineage dysplasia and CMML.
    E.2.2Secondary objectives of the trial
    Secondary Objectives for the Phase 1b (Safety Lead-In)
    • To assess the response rate (RR);
    • To assess other clinical efficacy measures;
    • To assess the rate of treatment emergent transfusion independence in patients who were transfusion dependent at study entry;
    • To characterize the PK of PF 04449913 and azacitidine alone and in combination;
    • To characterize any effects of PF 04449913 alone and in combination with azacitidine on QTc interval.

    Secondary Objectives for the Randomized Phase 2 Component
    • To compare the OS between treatment arms;
    • To compare the survival probabilities at 12, 18, and 24 months between treatment arms;
    • To compare the EFS between treatment arms;
    • To compare other clinical efficacy measures between treatment arms;
    • To compare the rate of treatment-emergent transfusion independence between treatment arms in patients who were transfusion dependent at study entry;
    Refer to Section 2.3 of the Protocol for further information
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study:

    1. Morphologically confirmed diagnosis of one of the following:
    a. MDS according to WHO 2008 classification (See Appendix 1 of the protocol), and bone marrow blasts ≥ 5%
    b. AML with 20-30 % BM or PB blasts and multi-lineage dysplasia, according to WHO 2008 classification(Appendix 1 of the protocol) and WBC < 20x109/L
    c. CMML according to the WHO 2008 classification (Appendix 1 of the protocol) and BM blasts between 10% - 19% and WBC < 13x109/L

    2. MDS patients must have intermediate-2 (1.5 to 2.0 points) or High-Risk (≥2.5 points) disease according to the International Prognostic Scoring System (IPSS).

    3. MDS patients must have normal levels of vitimin B12 within the institutional range of normal as determined within 28 days of study entry.

    4. AML pateients with 20-30% BM blasts and multi-linage dysplasia, must have stable blast counts per Investigator's judgment.

    5. Clinical indication for treatment with azacitidine for MDS, AML or CMML.

    6. Eastern Cooperatve Oncology Group (ECOG) Performance Status ≤2. See Appendix 11 of the protocol.

    7. ≥18 years of age.

    8. Adequate Renal Function:
    a. Serum creatinine ≤1.5 x upper limit of normal (ULN);
    OR
    b. Estimated creatinine clearance ≥60 ml/min (calculated using the standard method for the institution).

    9. Adequate Liver Function:
    a. Total serum bilirubin ≤1.5 x ULN (unless the bilirubin is principally unconjugated and there is strong suspicion of sub-clinical hemolysis or the patient has documented Gilbert's disease);
    b. Aspartate transaminase (AST) and Alanine transaminase ( ALT) ≤2.5 x ULN;
    c. Alkaline phosphatase ≤2.5 x ULN.

    10. Serum amylase or lipase <1.5 x ULN.

    11. Serum or urine pregnancy test (for female patients of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorinic gonadotropom (HCG) negative at screening.

    12. Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for 90 days after the last dose of azacitidine and the last dose of PF-04449913 or placebo, whichever occurs later.

    13. Female patients who are not of childbearing potential (ie, meet at least 1 of the following criteria):
    a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    b. Have medically confirmed overian failure; or
    c. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women.

    14. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

    15. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures (including BM assessments).
    E.4Principal exclusion criteria
    Patients with any of the following may not be included in the study:

    1. Patients with AML who are candidates for standard induction chemotherapy as first line treatment.

    2. Therapy-related (secondary to radiation or chemotherapy) MDS or
    AML.

    3. Prior hypomethylating agents or cytotoxic chemotherapy for MDS,
    AML or CMML (prior immunosuppressive therapy and hydroxyurea are permitted provided that treatment is stopped within 8 and 2 weeks from study entry, respectively).

    4. Previous hematopoietic stem cell transplant.

    5. Prior treatment with a licensed or experimental smoothened inhibitor
    (SMOi) and/or hypomethylating agent (HMA).

    6. Participation in a clinical study involving an investigational drug(s) (Phases 1-4) within 4 weeks prior to study entry.

    7. Major surgery or radiation within 12 weeks prior to study entry.

    8. Patients known to be refractory to platelet or packed red cell transfusions as per institutional guidelines, or who are known to refuse or who are likely to refuse blood product support.

    9. Treatment with hematopoietic growth factors including:
    erythropoietin, granulocyte colony stimulating factor (G-CSF), and granulocyte macrophage colony stimulating factor (GM-CSF), or
    thrombopoietin receptor agonists within 3 weeks prior to study entry.

    10. Any ongoing medical condition requiring chronic use of moderate to igh dose steroids (defined as ≥10 mg/day of prednisone or equipotent dose of another corticosteroid).

    11. Any anti-cancer treatment within 2 weeks prior to study entry.

    12. Current use or anticipated requirement for drugs that are known
    strong CYP3A4/5 inducers.

    13. Diagnosis of any malignant disease other than MDS, AML or CMML
    within the prior 12 months, with the exception of adequately treated: (i)
    in-situ carcinomas, (ii) basal or squamous cell carcinoma, or (iii) nonmelanoma
    skin cancer.

    14. Known malabsorption syndrome or other condition that may impair the absorption of the study drug (eg, gastrectomy, lap band, Crohn's
    disease) and inability or unwillingness to swallow tables or capsules.

    15. Patients with active, uncontrolled bacterial, fungal or viral infection,
    including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.

    16. Known uncontrolled central nervous system (CNS) involvement.

    17. Known moderate to severe chronic obstructive pulmonary disease,
    interstitial lung disease, or pulmonary fibrosis.

    18. Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, hepatic tumors, non-alcoholic steatohepatitis [NASH]).

    19. Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient
    ischemic attack or symptomatic pulmonary embolism; as well as
    bradycardia defined as <50 bpms .

    20. Active cardiac dysrhythmias of NCI CTCAE Grade ≥2 (eg, atrial fibrillation) or
    QTcF interval >470 msec.

    21. Pregnant or breastfeeding female patients.

    22. Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.

    23. Documented or suspected hypersensitivity to azacitidine or mannitol.

    24. Other severe acute or chronic medical or psychiatric conditions, including recent (within the past year) or active/ongoing suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or investigational product
    administration or may interfere with the interpretation of study results and that in the judgment of the investigator, would make the patient inappropriate for entry into the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints for the Phase 1b (Safety Lead-In)
    • Adverse events as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.4.03), timing, seriousness and relationship to study therapy and laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing.

    Primary Endpoints for the Randomized Phase 2

    • Response rate (Percentage of Patients achieving CR + PR) as defined by modified IWG criteria (2006)
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    E.5.2Secondary end point(s)
    Secondary Endpoints for the Phase 1b (Safety Lead-In)

    • Response rate (Percentage of Patients achieving Complete Remission CR) + Partial Remission (PR)) as defined by modified IWG criteria (2006);

    • Other efficacy measures HI, mCR, Cytogenetic Response, and SD as defined by modified IWG criteria (2006);

    • Proportion of patients becoming transfusion independent on-study in patients who were transfusion dependent at the time of study entry;

    • PK parameters of PF-04449913 and azacitidine, including but not limited to Cmax, Tmax and AUC;

    • QTc interval.

    Secondary Endpoints for the Randomized Phase 2
    • OS;
    • Survival probabilities at 12, 18, and 24 months;
    • lEFS;
    • Efficacy measures of HI, mCR, Cytogenetic Response, and SD as defined by modified
    IWG criteria (2006);
    •Proportion of patients becoming transfusion independent on-study in patients who were transfusion dependent at the time of study entry;
    • Duration of response;
    • Duration of HI;
    • Time to first response or any HI;
    • Time to best response or any HI;
    • Time to reaching >30% bone marrow blasts;
    • Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03), timing, seriousness and relationship to study therapy;
    • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing;
    • PROs of HRQOL as measured by the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) questionnaire and health status as measured by the EuroQol EQ-5D-5L self-report questionnaire Appendix 9 and Appendix 10;

    • Ctrough for PF-04449913;

    • QTc interval.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 18 and 24 months.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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) Yes
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Australia
    Austria
    Belgium
    Canada
    France
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Spain
    Taiwan
    United Kingdom
    United States
    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
    End of trial in a Member State of the EU is defined as the time at which it is deemed that a sufficient number of patients have been recruited and completed the study as stated in the regulatory application (ie, clinical trial application [CTA]) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 170
    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)
    Not Applicable
    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 Decision2015-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    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
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