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    Summary
    EudraCT Number:2009-010777-20
    Sponsor's Protocol Code Number:155-CL-031
    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:2010-06-22
    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 number2009-010777-20
    A.3Full title of the trial
    A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin’s Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of YM155 plus Rituximab in subjects with CD20 positive Non-Hodgkin's Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number155-CL-031
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01038804
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    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 supportAstellas Pharma Global Development, Inc. (APGD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Global Development, Inc. (APGD)
    B.5.2Functional name of contact pointT.B
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number3171545 5163
    B.5.5Fax number3171545 5840
    B.5.6E-mailpuma.smagge@eu.astellas.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 nameYM155
    D.3.2Product code YM155
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 781661-94-7
    D.3.9.2Current sponsor codeYM155
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameN/A
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 Yes
    D.2.1.1.1Trade name Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameN/A
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CD20-positive primary and transformed diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma (FL).
    E.1.1.1Medical condition in easily understood language
    Blood Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10029592
    E.1.2Term Non-Hodgkin's lymphomas NEC
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine objective response rate (ORR) (complete remission [CR] + partial remission [PR]) per modified [the International Working Group (IWG) Revised Response Criteria for Malignant Lymphomas (2007)].
    E.2.2Secondary objectives of the trial
    To evaluate the following:
    • Safety and tolerability of YM155 given in combination with rituximab.
    • CR Rate.
    • PR Rate.
    • Time to response.
    • Duration of response.
    • Clinical benefit rate (CBR).
    • Progression-free survival (PFS).
    • Overall survival (OS).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The pharmacogenomic sub-study is included in the main protocol.

    Study objectives are to comprehensively analyze:
    • Suspected disease-related genes such as oncogenes, survivin and vascular
    endothelial growth factor (VEGF)
    • Genes potentially involved in drug excretion and/or metabolism such as the
    organic anion/cation transporters (OAT, OCT)
    • Genes of relevance to toxicity/safety issues, to be identified in a
    precautionary / retrospective setting
    E.3Principal inclusion criteria
    A subject is eligible for the study if all of the following apply:
    1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved
    written Informed Consent and privacy language as per national regulations (e.g.,
    HIPAA Authorization for U.S. sites) must be obtained from the subject prior to
    any study-related procedures (including withdrawal of prohibited medication, if
    applicable).
    2. Male or female subject aged 18 years or older.
    3. Any stage, histologically confirmed CD20-positive primary or transformed DLBCL or
    grade 3 FL.
    4. Ineligible for or have previously received an ASCT.
    5. Subject must have relapsed or transformed from a low grade NHL to a DLBCL and have documented at least a PR that was maintained for 3 months prior to progression; following receipt of last dose of systemic chemotherapy or ASCT.
    6. At least one prior chemotherapy regimen.
    o Prior regimen must have contained anthracycline (unless contraindicated).
    o Any planned maintenance therapy should be considered as part of the
    previous treatment regimen.
    o Any preparative treatment (salvage chemotherapy, high-dose
    chemotherapy, radiation therapy, etc.) should be included with the ASCT
    as one treatment regimen.
    7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the
    Baseline Visit.
    8. Life expectancy greater than 12 weeks at the Baseline Visit based on Investigator's judgement.
    9. At least one measurable lesion ≥ 1.5 cm in the longest diameter (LDi) OR > 1.0 - ≤ 1.5 cm in LDi and > 1.0 cm in the shortest diameter (SDi) as assessed via diagnostic computed tomography (CT) or FDG PET scans.
    10. Subject with a previous history of non-CD20+ B cell NHL malignancy is eligible only if the subject meets the following:
    o Previous history of a non-invasive carcinoma if in the opinion of the investigator the subject has had potentially curative treatment prior to enrollment.
    o For all other malignancies, the subject has undergone potentially curative therapy and has been considered disease free for at least 5 years.
    11. Female subject must be either:
    • Of non-child bearing potential
    • post-menopausal (defined as at least 1 year without any mensus) prior to Screening, or
    • documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening), or
    • If of childbearing potential,
    • must have a negative serum or urine pregnancy test at Screening
    • must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after final study drug administration.
    12. Male subject and their female spouse/partners of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 28 days after final study drug administration.
    13. Female subject must not be breastfeeding at Screening or during the study period and for 28 days after final study drug administration.
    14. Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final study drug administration.
    15. Male subject must not donate sperm starting at Screening and throughout the study period and for at least 28 days after final study drug administration.
    16. Subject agrees not to participate in another interventional study while on treatment.
    *Note: Acceptable forms of birth control include established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), or barrier methods of contraception including a condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    E.4Principal exclusion criteria
    A subject will be excluded from participation if any of the following apply:
    1. Use of systemic steroids within 5 days of the Baseline Visit.
    o A subject receiving steroids at the time of the Baseline Visit is eligible as
    long as the subject is receiving a biologic dose or has been on a stable,
    non-biologic dose for at least 4 weeks prior to the first dose of YM155 and
    plans on continuing to receive the stable, non-biologic dose during study
    participation.
    o Systemic steroid use within 5 days of the Baseline Visit for the purposes
    of pre-medication prior to study regimen treatment is allowed.
    2. Prior allogeneic stem cell transplant (SCT).
    3. Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as:
    o Serum creatinine ≥ 1.5 x upper limit of normal (ULN) or calculated serum
    creatinine clearance < 60 mL/min.
    o Absolute neutrophil count (ANC) ≤ 1000/mm3.
    o Platelet ≤ 75,000/mm3.
    o Alanine transaminase (ALT) and Aspartate transaminase (AST)
    ≥ 2.5 x ULN or ≥ 5 x ULN if secondary to liver metastases.
    4. Central nervous system (CNS) or leptomeningeal involvement by lymphoma as
    determined by the Investigator through physical examination and medical history
    review at the Baseline Visit.
    5. The subject has significant and/or uncontrolled cardiac, renal, hepatic, or other
    systemic disorders or significant psychological conditions at the Baseline Visit that
    in the Investigator’s judgment would jeopardize subject enrollment or compliance
    with the study procedures.
    6. The subject has known human immunodeficiency virus (HIV), hepatitis B surface
    antigen, or hepatitis C antibody.
    7. The subject has been previously treated with YM155.
    8. The subject has received other investigational therapy or procedures within 21
    days prior to the first study drug administration.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the objective response rate (ORR). The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR assessed by the investigator.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The ORR will be calculated along with the corresponding exact two-sided 90% confidence interval (CI). For the full analysis, the study will be considered successful if there are at least 10 responders out of 34 PPS subjects.

    Subgroup analyses of ORR will be conducted on each level of the following baseline variables:
     Age (< 60-, >= 60)
     Race (White, Black, Asian, Other)
     Gender (Male, Female)
     ECOG performance status (0, 1)
     NHL sub-type (primary DLBCL, transformed DLBCL and grade 3 follicular lymphoma)
     Lymphoma Prognostic Index (low, intermediate, and high)
    E.5.2Secondary end point(s)
    To evaluate the following:
    • Safety and tolerability of YM155 given in combination with
    rituximab
    • Complete Remission Rate (CR)
    • Partial Remission Rate (PR)
    • Time to response
    • Duration of response
    • Clinical benefit rate (CBR)
    • Progression-free survival (PFS)
    • Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety:Assessed by physical examination,vitals,laboratory assessments,ECG,standard safety evaluations,recording of adverse events+assessment for toxicity.CR:Proportion of subjects with confirmed CR.PR:Proportion of subjects with confirmed PR.Time to Response:Time from 1st dose of study drug until 1st documentation of response(CR or PR).Duration of response:Time from 1st documentation of response(CR or PR) until objective tumor progression.CBR:Proportion of subjects with confirmed CR,confirmed PR and SD.PFS:Time from 1st dose of study drug until objective tumor progression or death.OS:Time from 1st dose of study drug until death.Follow-up survival will continue until subject death for no more than 1 year following EOT.
    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 No
    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
    Potential efficacy biomarkers
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of trial for all participating countries is defined as the date of the Last Subject’s Last Visit or date of Last Follow-up contact, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial days13
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 43
    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)
    After participation in the trial, patients will be treated with the current standard therapy or what is in the best interest of the patient's health at that time.
    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 Decision2010-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-23
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