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    The EU Clinical Trials Register currently displays   41008   clinical trials with a EudraCT protocol, of which   6704   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001048-40
    Sponsor's Protocol Code Number:B1371013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-001048-40
    A.3Full title of the trial
    A phase 2, double-blind, randomized safety and efficacy study of Glasdegib (PF-04449913) versus placebo in patients with Myelofibrosis previously treated with ruxolitinib.
    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 Glasdegib (PF-04449913) versus placebo in patients with Myelofibrosis.
    A.3.2Name or abbreviated title of the trial where available
    Glasdegib (PF-04449913)
    A.4.1Sponsor's protocol code numberB1371013
    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, 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
    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 codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.govcallcentre@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 nameGlasdegib
    D.3.2Product code PF-04449913
    D.3.4Pharmaceutical form Film-coated 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 INNGlasdegib
    D.3.9.2Current sponsor codePF-04449913
    D.3.9.4EV Substance CodeSUB31245
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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 nameGlasdegib
    D.3.2Product code PF-04449913
    D.3.4Pharmaceutical form Film-coated 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 INNGlasdegib
    D.3.9.2Current sponsor codePF-04449913
    D.3.9.4EV Substance CodeSUB31245
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Myelofibrosis
    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 19.0
    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
    Lead-in Cohort

    • To assess the safety and tolerability of PF-04449913 in patients with primary or secondary MF who have been previously treated with ≥1 JAKi.

    Randomized Cohort

    • To compare the effect of PF-04449913 vs. placebo on SVR in patients with primary or secondary MF who have been previously treated with ruxolitinib.
    E.2.2Secondary objectives of the trial
    Lead-in Cohort

    • To assess the effect of PF-04449913 on spleen volume reduction (SVR) in patients with primary or secondary MF who have been previously treated with ≥1 JAKi.
    • To assess the effect of PF-04449913 on patient reported MF symptoms in patients with primary or secondary MF who have been previously treated with ≥1 JAKi.
    • To assess the effect of PF-04449913 on hematologic improvement (peripheral blood) in patients with primary or secondary MF who have been previously treated with ≥ 1 JAKi.
    • To characterize the pharmacokinetics (PK) of PF-04449913.

    Randomized Cohort

    • To compare the symptomatic efficacy of PF-04449913 vs. placebo on patient reported MF symptoms in patients with primary or secondary MF who have been previously treated with ruxolitinib;
    Please refer to Section 2.2.2 of the Protocol for the additional Randomized Cohort Secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

    1. Diagnosis of primary MF (PMF) or secondary MF (PET-MF and PPV-MF) as per WHO 2008 criteria.

    2. Lead-in cohort only: Prior treatment with ≥1 JAKi (must meet one of the following criteria):

    a. Previous treatment with ≥1 JAKi (licensed or experimental) for a minimum duration of ≥4 weeks and failure to achieve or sustain adequate symptomatic control and/or achieve or sustain an adequate reduction of splenomegaly (Investigator’s judgment);

    b. JAKi therapy discontinuation for unacceptable toxicity irrespective of the duration of therapy.

    3. Randomized cohort: At least one of the following criteria for prior ruxolitinib resistance OR intolerance must be met:

    a. Primary Resistance

    i. No reduction in spleen volume (MRI/CT) or size (manual palpation from below left inferior costal margin) following treatment with ruxolitinib for at least 12 weeks.

    b. Secondary Resistance:

    i. Increase in spleen volume (assessed by MRI/CT) from nadir by ≥25% at any time following the start of ruxolitinib therapy; OR

    ii. Appearance for new splenomegaly palpable at least 5cm below the left inferior costal margin; OR

    iii. Increase in spleen size (manual palpation from below the left inferior costal margin) by ≥50% from nadir (or ≥100% if nadir is <5 cm) in the context of worsening splenomegaly-related abdominal pain or other disease-related signs/symptoms at any time following the start of ruxolitinib therapy.

    c. Intolerance

    i. Anaphylaxis or Grade 3/4 allergic reactions following any duration of ruxolitinib therapy; OR

    ii. In accordance with the dose modification guidelines in the ruxolitinib prescribing information, documentation in the medical record of the presence of ruxolitinib-related toxicity/toxicities that resulted in ruxolitinib discontinuation.

    4. Documentation by the Investigator that the patient has exhausted available treatment options (eg, resistant or intolerant to hydroxyurea, etc).

    5. Spleen ≥5 cm below the inferior left costal margin (LCM) as measured by manual palpation.

    6. Active symptomatic MF as defined by the screening MPN-SAD patient reported instrument requiring a severity score of at least 5 on one symptom, or a severity score of ≥3 on at least two of the symptoms (on a 0 to 10 scale) (Appendix 1):
    a. Early satiety;
    b. Abdominal discomfort (pressure or bloating);
    c. Inactivity (including work, home and social activities);
    d. Nights sweats;
    e. Pruritus;
    f. Bone pain (other than arthritis or joint pains);
    g. Pain below the ribs on the left-hand side;
    h. Fatigue;
    i. Shortness of breath.

    7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3.

    8. The following laboratory values:

    a. Absolute Neutrophil Count (ANC) >.75 x 109/L;

    b. Platelet count >50 x 109/L with no evidence of bleeding and not requiring platelet transfusions;

    c. Serum creatinine <1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥-60mL/min (as calculated using the standard method of institution);

    d. Serum amylase or lipase <1.5 x ULN;

    e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤3.0 x ULN (or ≤5x ULN in the case of patients with MF accompanied by hepatic extramedullary hematopoiesis, as manifested by any degree of hepatomegaly).

    f. Total bilirubin values <1.5 x ULN unless the bilirubin is principally unconjugated (in the context of hemolysis) or there is documented Gilbert’s disease.

    g. Serum electrolyte values < Grade 2 (sodium, potassium, calcium, phosphorous and magnesium), .per CTCAE v.4.03.

    9. Recovery to ≤ Grade 1 from all clinically significant adverse events related to prior MF therapy, including transplant related toxicities.

    10. More than 2 months out from allogenic hematopoietic stem cell transplant prior to randomization.

    11. Must be able to undergo MRI of abdomen (spleen and liver). Patients who are contra-indicated for MRI may be enrolled and evaluated by CT scan at the discretion of the Sponsor.

    12. ≥18 years of age.

    13. Male subjects able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method of contraception throughout the study and for 90 days after the last dose of assigned treatment.

    14. Serum or urine pregnancy test (for females of childbearing potential) negative at screening .

    15. 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.

    16. Patients who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:

    1. Prior treatment with a licensed or experimental smoothened inhibitor (SMOi).

    2. Randomized cohort only: Prior treatment with a Janus Kinase (JAK) inhibitor other than ruxolitinib.

    3. Other anti-cancer therapy up to 14 days prior to enrollment, with the exception of hydroxyurea, which can be given up to 4 days prior to enrollment.

    4. Splenic irradiation ≤3 months prior to enrollment.

    5. History of congenital long QT syndrome, or a baseline >470 msec QTcF abnormality (average of the triplicate reading),

    6. Evidence of significant cardiac disease, for example: symptomatic cardiac heart failure (CHF, NYHA ≥ class 3), complete bundle branch block, significant atrial or ventricular tachyarrythmias and any unstable cardiac arrhythmias requiring medication.

    7. History of myocardial infarction or unstable angina within 6 months prior to enrollment.

    8. Uncontrolled inflammatory bowel disease, peptic ulcer disease or history of significant gastro-intestinal bleeding within 6 months of enrollment.

    9. Any condition requiring chronic use of moderate/high dose steroids (equivalent to ≥10 mg QD prednisone).

    10. Hematopoietic growth factor receptor agonists (eg, erythropoietin (Epo)), granulocyte colony stimulating factor (GCSF), romiplostim, eltrombopag within 28 days of enrollment.

    11. Currently active malignancy (other than MF). Prior malignancies are allowed so long as there is no evidence of disease recurrence within the last 2 years (with the exception of fully excised, non-complicated basal cell carcinoma which can have been active within the prior 2 years, and certain localized, non-invasive fully excised skin, cervical, breast, prostate or bladder tumors).

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

    13. 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.

    14. Active graft versus host disease (GVHD) with other than grade 1 skin involvement or GVHD requiring immunosuppressive treatment.

    15. Uncontrolled disseminated intravascular coagulation.

    16. Current (including their administration within 3-days prior to study entry) use or anticipated need for food or drugs that are strong CYP3A4 inhibitors. Please refer to Appendix 8 for a list of strong inhibitors.

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

    18. Patients who are investigational site staff members directly involved in the conduct of the trial 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 trial.

    19. Participation in other clinical trials with investigational agents (Phases 1-4) within 28 days prior to first dose of study treatment.

    20. Other severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior as judged by the treating physician or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

    21. Pregnant female patients; breastfeeding female patients; male subjects able to father children and female patients of childbearing potential who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product or longer, based upon the compound’s half-life characteristics.
    E.5 End points
    E.5.1Primary end point(s)
    Lead-in Cohort:
    Adverse events (AEs) 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.
    Laboratory abnormalities as characterized by: type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing.

    Randomized Cohort
    Proportion of patients achieving SVR ≥35% at Week 24 as measured
    by MRI (or CT, in patients unable to tolerate an MRI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be reached at Week 24
    E.5.2Secondary end point(s)
    Lead-in Cohort
    • Proportion of patients achieving SVR ≥35% at Week 24 as measured by MRI (or computed tomography (CT) in patients unable to tolerate an MRI);
    • Proportion of patients achieving ≥50% reduction in total symptom score (TSS) at Week 24, as measured by the Myeloproliferative Neoplasms Symptom Assessment Diary (MPN-SAD);
    • Overall total symptom score (TSS) as measured by MPN-SAD;
    • Proportion of patients with improvement in peripheral blood counts, as defined by the Revised IWG-MRT Response Criteria13 (Appendix 6);
    • Pharmacokinetic parameters of PF-04449913, including but not limited to Cmax, Tmax, AUC and Cavg.

    Randomized Cohort
    • Proportion of patients achieving ≥50% reduction in TSS at Week 24, as measured by the MPN-SAD;
    • Overall TSS at Week 24, as measured by MPN-SAD;
    • Proportion of patients with improvement in peripheral blood counts, as defined by the Revised IWG-MRT Response Criteria13 (Appendix 6);
    • Patient Reported Outcome (PRO) of health-related quality of life as measured by the European Organisation for Research and Treatment of Cancer (EORTC QLQ-30), Health status as measured by the EuroQol EQ-5D Self-Report Questionnaire (EQ-5D-5L) and Patient Global Impression of Change (PGIC);
    • Duration of spleen volume reduction;
    • OS;
    • 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;
    • Pharmacokinetic parameters of PF-04449913, including but not limited to Cmax, Tmax, AUC and Cavg;
    • Psychometric validation of the MPN-SAD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be reached at Week 24
    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 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) No
    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 EEA56
    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
    Belgium
    France
    Germany
    Israel
    Italy
    Japan
    Netherlands
    Spain
    United Kingdom
    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
    End of Study in a Member State of the EU is defined as the time at which it is deemed that sufficient patients have been recruited and completed the study as stated in the regulatory application and ethics application in the Member State. Poor recruitment by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.

    End of Study in all other participating countries is defined as Last Patient Last Visit.
    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 months4
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 133
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 157
    F.4.2.2In the whole clinical trial 222
    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)
    N/A
    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 Decision2014-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-31
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