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    Summary
    EudraCT Number:2014-002069-31
    Sponsor's Protocol Code Number:PCYC-1130-CA
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-002069-31
    A.3Full title of the trial
    A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton’s Tyrosine Kinase Inhibitor Ibrutinib in Combination with Obinutuzumab versus Chlorambucil in Combination with Obinutuzumab in Subjects with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    Randomizované, multicentrické, otevřené klinické hodnocení 3. fáze
    porovnávající inhibitor Brutonovy tyrosinkinázy ibrutinib v kombinaci s
    obinutuzumabem a chlorambucil v kombinaci s obinutuzumabem u
    pacientů s chronickou lymfocytární leukemií nebo lymfomem z malých
    lymfocytů, kteří dosud nepodstoupili žádnou léčbu.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate use of Ibrutinib with Obinutuzumab versus use of Chlorambucil with Obinutuzumab in Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    A.4.1Sponsor's protocol code numberPCYC-1130-CA
    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 SponsorPharmacyclics LLC
    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 supportPharmacyclics LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacyclics LLC
    B.5.2Functional name of contact pointClinical Trial information
    B.5.3 Address:
    B.5.3.1Street Address995 East Arques Avenue
    B.5.3.2Town/ citySunnyvale, California
    B.5.3.3Post code94085
    B.5.3.4CountryUnited States
    B.5.4Telephone number+14087740330
    B.5.5Fax number+14087740340
    B.5.6E-mailinfo@pcyc.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/12/984-EMA/OD/156/11
    D.3 Description of the IMP
    D.3.1Product nameIMBRUVICA
    D.3.2Product code PCI-32765
    D.3.4Pharmaceutical form Capsule, hard
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codePCI 32675 (Ibrutinib)
    D.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB88115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 RoleComparator
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1054
    D.3 Description of the IMP
    D.3.1Product nameObinutuzumab
    D.3.2Product code RO 5072759 / GA101
    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 INNObinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeGA101
    D.3.9.4EV Substance CodeSUB32751
    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 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 No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 LEUKERAN®
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Global Incorporated
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNCHLORAMBUCIL
    D.3.9.1CAS number 305-03-3
    D.3.9.4EV Substance CodeSUB06172MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    E.1.1.1Medical condition in easily understood language
    Leukemia or Lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003908
    E.1.2Term B-cell small lymphocytic lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression-free survival (PFS) in subjects with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
    E.2.2Secondary objectives of the trial
    To compare the treatment groups in terms of the following:
    Efficacy
    • Overall response rate (ORR) according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria, as assessed by the IRC
    • Rate of minimal residual disease (MRD)-negative responses
    • Overall Survival
    • Hematological improvement measured by platelet and hemoglobin counts
    • Patient-reported outcomes (PRO) as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire EuroQoL Five-Dimension (EQ-5D-5L)
    Safety
    • To evaluate the safety and tolerability of ibrutinib in combination with obinutuzumab compared with chlorambucil in combination with obinutuzumab
    •To evaluate obinutuzumab-related infusion reactions by treatment arm
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease Related
    1. Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria (Hallek 2008)
    2. Age 65 yrs and older OR if less than 65 years old, must have at least one of the following criteria:
    a) Cumulative Index Rating Score (CIRS) >6
    b) Creatinine clearance <70 mL/min using the Cockcroft-Gault equation
    c) Del17p by FISH or TP53 mutation by PCR or Next Generation Sequencing (NGS)
    3. Active disease meeting at least 1 of the following IWCLL criteria (Hallek 2008) for requiring treatment:
    a) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
    b) Massive, progressive, or symptomatic splenomegaly
    c) Massive nodes or progressive or symptomatic lymphadenopathy
    d) Progressive lymphocytosis
    e) Autoimmune hemolytic anemia and/or immune thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
    f) Constitutional symptoms
    4. Measurable nodal disease by computed tomography (CT)
    Laboratory
    5. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to Screening and randomization:
    a) Absolute neutrophil count ≥1.0 x 10 to the ninth power/L
    b) Platelet count >50 x 10 to the ninth power/L
    6. Adequate hepatic and renal function defined as:
    a) Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 2.5 x ULN.
    b) Estimated Creatinine Clearance ≥30 mL/min (Cockcroft-Gault)
    c) Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
    Demographic
    7. Men and women ≥18 years of age.
    8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    Ethics/other
    9. Willingness to receive all outpatient treatment, all laboratory monitoring, and all radiological evaluations at the institution that administers study drug for the entire study
    10. Ability to provide written informed consent and to understand and comply with the requirements of the study
    11. Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.
    12. Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of ibrutinib/chlorambucil or obinutuzumab, and at least 18 months after the last obinutuzumab dose for female subjects.
    E.4Principal exclusion criteria
    1. Any prior chemotherapy, radiotherapy, small molecule inhibitors including kinase inhibitors, and/or monoclonal antibody used for treatment of CLL or SLL
    2. Evidence of central nervous system (CNS) involvement with primary disease of CLL/SLL
    3. History of other malignancies, except:
    a) Malignancy treated with curative intent and with no known active disease present for ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
    b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    c) Adequately treated carcinoma in situ without evidence of disease.
    4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, such as those subjects with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study drug, or the need for daily prednisone ≥20 mg daily (or corticosteroid equivalent) to control the autoimmune disease.
    5. Known or suspected history of Richter’s transformation.
    6. Concurrent administration of >20 mg/day of prednisone within 7 days of randomization unless indicated for prophylaxis or management of allergic reactions (eg, contrast).
    7. Known hypersensitivity to one or more study drugs.
    8. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
    9. Any uncontrolled active systemic infection or infection requiring systemic treatment that was completed ≤7 days before randomization.
    10. Known bleeding disorders (eg, von Willebrand’s disease) or hemophilia.
    11. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
    12. Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
    13. Major surgery within 4 weeks of first dose of study drug.
    14. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk.
    15. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
    16. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting
    gastrointestinal function, or resection of the stomach or small bowel, symptomatic
    inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
    17. Concomitant use of warfarin or other Vitamin K antagonists.
    18. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
    19. Lactating or pregnant.
    20. Unwilling or unable to participate in all required study evaluations and procedures.
    21. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is progression-free survival (PFS) as assessed by IRC review, according to IWCLL 2008 criteria. PFS will be analyzed comparing the 2 treatment arms using a log-rank test. Distribution of PFS will be summarized for each treatment arm using the Kaplan-Meier estimate of median and its corresponding 95% confidence interval (CI). The estimate of the hazard ratio and its corresponding 95% CI will be computed using a Cox proportional hazards model.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoints will be determined once there are 94 events in approximately 36 months from the first subject randomized.
    E.5.2Secondary end point(s)
    -Overall response rate: the chi-square test will be used to compare the two treatment arms.
    • Rate of MRD-negative response: the chi-square test will be used to compare the two treatment arms.
    • Overall survival: the two treatment arms will be summarized using Kaplan-Meier point estimates
    • Hematological improvement: in the subset of subjects with cytopenia(s) at baseline, the percentage of subjects with hematological improvement in the two treatment arms will be measured and compared using the chi-square test.
    • EQ-5D-5L: the scores for the five categorical dimensions will be used to compute a single utility score ranging representing the general health status of the subject. The change in utility score from baseline will be summarized. Methods will be detailed in SAP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints will be determined once there are 94 events in approximately 36 months from the first subject randomized.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Czech Republic
    France
    Israel
    Italy
    New Zealand
    Poland
    Russian Federation
    Spain
    Sweden
    Turkey
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 185
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 229
    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)
    All subjects will undergo an End-of-Treatment visit up to 30 days after discontinuation of randomized treatment (and/or discontinuation of ibrutinib cross-over therapy for subjects randomized to Treatment Arm B) or prior to starting a new anticancer treatment.
    All subjects then will be followed for survival and subsequent anti-cancer therapies.
    The Follow-up Phase will continue until death, loss to follow up, consent withdrawal, or study closure, whichever occurs first.
    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 Decision2015-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-03
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