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    Summary
    EudraCT Number:2011-000830-12
    Sponsor's Protocol Code Number:E5501-G000-302
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-08
    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 ConcernedGreece - EOF
    A.2EudraCT number2011-000830-12
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberE5501-G000-302
    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 SponsorEisai Limited
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Incorporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Limited
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressEuropean Knowledge Centre, Mosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408456761400
    B.5.5Fax number+4408456761401
    B.5.6E-mailLmedInfo@eisai.net
    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 nameE5501
    D.3.2Product code E5501
    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 INNAvatrombopag (proposed)
    D.3.9.1CAS number 1254322-84-3
    D.3.9.2Current sponsor codeE5501
    D.3.9.3Other descriptive nameAKR-501, YM-477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.3.11.13.1Other medicinal product typeNot applicable
    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 nameE5501
    D.3.2Product code E5501
    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 INNAvatrombopag (proposed)
    D.3.9.1CAS number 1254322-84-3
    D.3.9.2Current sponsor codeE5501
    D.3.9.3Other descriptive nameAKR-501, YM-477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.3.11.13.1Other medicinal product typeNot applicable
    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 nameE5501
    D.3.2Product code E5501
    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 INNAvatrombopag (proposed)
    D.3.9.1CAS number 1254322-84-3
    D.3.9.2Current sponsor codeE5501
    D.3.9.3Other descriptive nameAKR-501, YM-477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.3.11.13.1Other medicinal product typeNot applicable
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    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
    Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
    E.1.1.1Medical condition in easily understood language
    Low platelet count, which has lasted for more than a year, caused because platelets (and the cells that produce platelets in the bone marrow) are destroyed by antibodies in the blood.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level HLGT
    E.1.2Classification code 10035534
    E.1.2Term Platelet disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10043554
    E.1.2Term Thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10036735
    E.1.2Term Primary thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Core Study
    To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured by durable platelet response

    Extension Phase
    To evaluate the safety and tolerability of long-term therapy with E5501 in subjects with chronic ITP (cITP)
    E.2.2Secondary objectives of the trial
    Core Study
    • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to the efficacy of placebo (in addition to standard of care) as measured by platelet response rate at Day 8
    • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to the efficacy of placebo (in addition to standard of care) as measured by an alternate durable response
    • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to the efficacy of placebo (in addition to standard of care) as measured by the proportion of subjects with reduction in concomitant ITP medication use
    • To evaluate the safety of E5501 compared with placebo

    Extension Phase
    • To demonstrate the effectiveness of long-term therapy with E5501 as measured by platelet response, bleeding, and the use of rescue therapy
    • To assess the reduction in use of steroids and concomitant ITP medication in subjects receiving E5501
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Core Study
    1. Men and women ≥ 18 years of age
    2. Subjects diagnosed with cITP (≥12 months duration) according to the ASH/BCSH guidelines, with an average of two platelet counts < 30 × 109/L (no single count may be >35 × 109/L). In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia (e.g., pseudothrombocytopenia, myelofibrosis). The physical examination should not suggest any disease which may cause thrombocytopenia other than ITP.
    3. Subjects who previously received one or more ITP therapies (including but not limited to corticosteroids, immunoglobulins, azathioprine, danazol, cyclophosphamide, and/or rituximab).
    4. Subjects must have either initially responded (platelet count >50 × 109/L) to a previous ITP therapy or have had a bone marrow examination consistent with ITP within 3 years to rule out myelodysplastic syndrome (MDS) or other causes of thrombocytopenia.
    5. Prothrombin time/International Normalized Ratio and activated partial thromboplastin time must have been within 80% to 120% of the normal range with no history of hypercoagulable state.
    6. A complete blood count (excluding platelet count), within the reference range (with white blood count [WBC] differential not indicative of any significant hematological disorder), with the following exceptions:
    • Hemoglobin: Subjects with hemoglobin levels between 10 g/dL (100 g/L) and the lower limit of normal (LLN) are eligible for inclusion, if anemia is clearly attributable to ITP (excessive blood loss).
    • Absolute neutrophil count (ANC) ≥ 1500/μL (1.5 x 109/L)was required for inclusion (elevated WBC/ANC due to corticosteroid treatment is acceptable).
    • Elevated WBC or ANC (e.g., due to corticosteroid treatment) provided this is discussed with the medical monitor (revised per Amendment 01)

    Extension Phase
    1. Subjects who have completed 6 months of study treatment in the Randomization Phase or
    2. Subjects who discontinue the Core Study early due to lack of treatment effects. (see Study Drug Discontinuation)
    3. No significant safety or tolerability concerns with the subject’s
    participation of Randomization Phase as determined by the investigator.
    E.4Principal exclusion criteria
    Core Study
    1. Subjects with known secondary immune thrombocytopenia (e.g., with known Helicobacter pylori-induced ITP, subjects infected with known human immunodeficiency virus [HIV] or hepatitis C virus [HCV] or subjects with known systemic lupus erythematosus) (Revised per Amendment 01)
    2. Subjects considered unable or unwilling to comply with the study protocol requirements or give informed consent, as determined by the investigator
    3. Subjects with significant medical conditions that may impact the safety of the subject or interpretation of the study results (e.g., acute hepatitis, active chronic hepatitis, lymphoproliferative disease myeloproliferative disorders, leukemia)
    4. History of MDS
    5. History of gastric atrophy (added per Amendment 01)
    6. History of pernicious anemia or subjects with vitamin B12 deficiency (defined as <LLN) who have not had pernicious anemia excluded as a cause (added per Amendment 01)
    7. Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), and more than
    two of the following risk factors: estrogen-containing hormone replacement or contraceptive therapies, smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.), or any other family history of arterial or venous thrombosis
    8. Subjects with a history of significant cardiovascular disease (e.g., congestive heart failure [CHF] New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events [e.g., atrial fibrillation], subjects with a QTc > 450 msec, angina, coronary artery stent placement, angioplasty, coronary artery bypass grafting)
    9. Subjects with a history of cirrhosis, portal hypertension, and chronic active hepatitis
    10. Subjects with concurrent malignant disease
    11. Use of immunoglobulins (IVIg and anti-D) within 1 week of randomization
    12. Splenectomy or use of rituximab within 12 weeks of randomization
    13. Use of romiplostim or eltrombopag within 4 weeks of randomization
    14. Subjects who are currently treated with corticosteroids or azathioprine but have not been receiving a stable dose for at least 4 weeks prior to randomization or have not completed these therapies more than 4 weeks prior to randomization
    15. Subjects who are currently treated with MMF, CsA, or danazol
    but have not been receiving a stable dose for at least 12 weeks prior to randomization or have not completed these therapies more than 4 weeks prior to randomization
    16. Use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of randomization.
    17. Subjects who are currently treated with proton pump inhibitors (PPIs) or H2 antagonist therapy but have not been receiving a stable dose for at least 6 weeks prior to randomization or have not completed these therapies more than 2 weeks prior to randomization
    18. Fasting gastrin-17 blood levels exceeding the upper limit of normal (ULN) at Screening for subjects not on PPIs or H2 antagonists (revised per Amendment 01)
    19. Fasting gastrin-17 blood levels exceeding 1.5 times the ULN at Screening for subjects on PPIs or H2 antagonists (added per Amendment 01)
    20. Blood creatinine exceeding ULN by more than 20% OR total albumin below the lower
    limit (LLN) of normal by 10% (revised per Amendment 01)
    21. Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) levels exceeding 3 times the ULN OR total bilirubin exceeding 2 times the ULN (revised per Amendment 01)
    22. Subjects with a history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy. Subjects with a history of ITP treatment with cytotoxic chemotherapy are still eligible for enrollment.
    23. Females who are pregnant (positive beta-human chorionic gonadotropin positive [β-hCG] test) or breastfeeding
    24. Subjects with a known allergy to E5501 or its excipients
    25. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study
    conduct
    26. Any history of or concomitant medical condition thatwould compromise the subject’s ability to safely complete the study
    27. Subjects who have participated in another investigational trial within 30 days prior to Day 1 Baseline/Randomization

    Extension Phase
    1. Subjects for whom participation in the Extension Phase is considered unsafe, based on the investigator’s judgment.
    2. Subjects considered unable, or unwilling to comply with the study protocol requirements or give informed consent, as determined by the investigator.
    3. Subjects requiring the following drugs or treatments at the time of enrollment in the Extension Phase:
    a) Rituximab
    b) Splenectomy
    c) Other TPO agonists
    E.5 End points
    E.5.1Primary end point(s)
    Core Study
    Proportion of subjects who have at least 6 of 8 (i.e., ≥75%) weekly platelet responses during the last 8 weeks of treatment (i.e., Visits 15 to 22, inclusive) over the 6-month treatment period in the absence of rescue therapy.

    Subjects using rescue therapy at any time during the 6-month treatment period will be considered to not have a durable platelet response

    A platelet response will be defined as a platelet count of ≥ 50 x 109/L and nonresponse will be defined as a platelet count < 50 x 109/L.

    Missing platelet assessments at any given time point will be
    considered to be a nonresponse at that time point. Subjects who discontinue the study or who are lost to follow-up before 6 months
    will have all subsequent unobserved scheduled platelet assessments at the scheduled time points as having “missing” platelet values.

    All analyses of platelet counts will be based on local laboratory
    results.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the last 8 weeks of treatment (i.e., at Visits 15 to 22, inclusive) over the 6-month treatment period in absence of rescue therapy.
    E.5.2Secondary end point(s)
    • Platelet response rate at Day 8 (as defined by the proportion of subjects with a platelet response ≥50 x 109/L at Day 8). Subjects with missing platelet counts at Day 8 or use of a rescue therapy before or on Day 8, will be considered platelet nonresponders.
    • Alternative durable platelet response as defined by: proportion of subjects with at least 75% of platelet assessments between ≥ 50 x 109/L and ≤ 400 x 109/L from the time of first response over a 6-month treatment period in the absence of rescue therapy (durability by flexible period)
    • Proportion of subjects with a reduction in use of concomitant ITP medications from baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Day 8
    • From the time of first response over a 6-month treatment period (in the absence of rescue therapy).
    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
    Open label extension
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.2.3.1Comparator description
    Open-label extension
    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 EEA30
    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
    Belgium
    Bulgaria
    China
    Czech Republic
    Greece
    Hong Kong
    Netherlands
    New Zealand
    Poland
    Romania
    Singapore
    Slovakia
    South Africa
    Ukraine
    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 months11
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 84
    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 Decision2012-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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