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    Summary
    EudraCT Number:2012-003967-23
    Sponsor's Protocol Code Number:PCYC-1115-CA
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-29
    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 ConcernedIreland - HPRA
    A.2EudraCT number2012-003967-23
    A.3Full title of the trial
    A Randomized, Multicenter, Open-label, Phase 3 Study of the
    Bruton’s Tyrosine Kinase Inhibitor PCI-32765 versus
    Chlorambucil in Patients 65 Years or Older with Treatment-naive
    Chronic Lymphocytic Leukemia or Small Lymphocytic
    Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Multicenter, Open-label, Phase 3 Study of the
    Bruton’s Tyrosine Kinase Inhibitor PCI-32765 versus
    Chlorambucil in Patients 65 Years or Older with Treatmentnaive
    Chronic Lymphocytic Leukemia or Small Lymphocytic
    Lymphoma
    A.4.1Sponsor's protocol code numberPCYC-1115-CA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01722487
    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, Incorporated
    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, Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacyclics, Incorporated
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address995 East Arques Avenue
    B.5.3.2Town/ citySunnyvale, CA
    B.5.3.3Post code94085-4521
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014082153770
    B.5.5Fax number0014082153684
    B.5.6E-maillstyles@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 numberEMA/OD/156/11
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    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-32765
    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 Yes
    D.2.1.1.1Trade name Leukeran (Chlorambucil)
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    Treatment-naive 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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10060669
    E.1.2Term B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/small lymphocytic lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of PCI-32765 compared with chlorambucil
    based on the Independent Review Committee (IRC) assessment of
    progression-free survival (PFS) in patients 65 years of age or older
    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 complete
    responses (CRs)
    • Overall survival (OS)
    • Fatigue measured by Functional Assessment of Chronic Illness
    Therapy-Fatigue (FACIT-F)
    • Hematological improvement measured by hemoglobin and platelet
    counts

    Safety
    • To evaluate the safety and tolerability of PCI-32765 compared with chlorambucil
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females of 65 years of age or greater. Patients between
    the ages of 65 and 70 years of age must have 1 or more of the following comorbidities that may preclude the use of frontline chemo-immunotherapy with fludarabine, cyclophosphamide or rituximab:
    • Creatinine clearance < 70 mL/min using the Cockcroft-Gault equation
    • Platelet count < 100,000/μLor hemoglobin < 10 g/dL
    • Clinically apparent autoimmune cytopenia (autoimmune hemolytic
    anemia or immune thrombocytopenia): Autoimmune hemolytic anemia is defined by at least one marker of hemolysis indirect bilirubin above the upper limit of normal (ULN) not due to liver disease, increased lactate dehydrogenase (above ULN) without alternative etiology, or increased absolute reticulocytosis (above ULN) or bone marrow erythropoiesis in the absence of bleeding) AND at least one marker of direct or indirect autoimmune mechanism (positive direct antiglobulin for IgG or C3d, cold agglutinins) (Ding 2007).; Immune thrombocytopenia is defined by
    platelets ≤ 100,000/μL and increased megakaryocytes on the bone
    marrow exam.
    • Eastern Cooperative Oncology Group (ECOG) performance score = 1 or 2
    2. Diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008):
    • Monoclonal B cells (either kappa or lambda light chain restricted) that are clonally coexpressing at least 1 B-cell marker (CD19 or CD20) and CD5.
    • Prolymphocytes may comprise no more than 55% of blood lymphocytes.
    3. Active disease meeting at least 1 of the following IWCLL criteria (Hallek 2008) for requiring treatment:
    • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL)
    • Massive (≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly
    • Massive nodes (at least 10 cm longest diameter), or progressive or symptomatic lymphadenopathy
    • Progressive lymphocytosis with an increase of more than 50%over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of < 30,000/μL, LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded.
    • Autoimmune hemolytic anemia and/or immune thrombocytopenia
    (defined in Inclusion Criterion 1) that is poorly responsive to corticosteroids or other standard therapy (but see Exclusion Criterion 4).
    • Constitutional symptoms, defined as one or more of the following disease-related symptoms or signs, documented in the patient’s record prior to randomization:
    − unintentional weight loss > 10% within 6 months prior to screening
    − significant fatigue (inability to work or perform usual activities)
    − fevers > 100.5°F or 38.0°C for 2 or more weeks prior to screening without evidence of infection
    − night sweats for more than 1 month prior to screening without evidence of infection
    4. Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node > 1.5 cm in the longest diameter in a site that has not been previously irradiated. An irradiated lesion may be assessed for measurable disease only if there has been documented progression in that lesion since radiotherapy has ended.
    5. ECOG performance status of 0–2.
    6. Life expectancy > 4 months from randomization.
    7. Adequate hematologic function, defined as absolute neutrophil count (ANC) ≥ 1,000/μL (independent of growth factor support for at least 7 days prior to screening) and platelet count ≥ 50,000/μL (independent of transfusion and growth factor support for at least 7 days prior to screening).
    8. Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x ULN, and total bilirubin ≤ 1.5 x ULN (unless due to Gilbert's syndrome).
    9. Adequate renal function, defined as estimated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation.
    10. Willingness to receive all outpatient treatment, all laboratory monitoring, and all radiological evaluations at the institution that administers study drug for the entire study.
    11. Willingness of male patients, if sexually active with a female of childbearing potential, to use an effective barrier method of contraception during the study and for 3 months following the last
    dose of study drug.
    12. Ability to provide written informed consent and to understand and comply with the requirements of the study.
    E.4Principal exclusion criteria
    1. Known involvement of the central nervous system by lymphoma
    or leukemia.
    2. History or current evidence of Richter’s transformation or prolymphocytic leukemia.
    3. Documentation of deletion of the short arm of chromosome17: del (17p13.1), as defined by del 17p in more than 20% of cells examined on any pretreatment fluorescence in situ hybridization (FISH) or cytogenetic evaluation.
    4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, such as those patients 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. Any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat CLL/SLL.
    6. Received any immunotherapy, live vaccine, or investigational drug within 4 weeks prior to randomization.
    7. Corticosteroid use >20 mg prednisone daily (or corticosteroid equivalent, see Appendix M) within 1 week prior to first dose of study drug, with the exception of inhaled, topical, or other local
    administrations. Patients requiring systemic steroids at daily doses >20mg prednisone (or corticosteroid equivalent), or those who are administered steroids for leukemia control or white blood cell (WBC)-count-lowering are excluded
    8. Major surgery within 4 weeks prior to randomization
    9. History of prior malignancy, with the exception of the following:
    • Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician.
    • Adequately treated nonmelanomatous skin cancer or lentigo maligna melanoma without current evidence of disease.
    • Adequately treated cervical carcinoma in situ without current evidence of disease.
    10. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York HeartAssociation Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
    11. Inability to swallow capsules or tablets, or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (including malabsorption syndrome, resection of the small bowel, or poorly controlled inflammatory bowel disease).
    12. Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection, and without improvement despite appropriate antibiotics or other treatment), or requirement for intravenous (IV) antibiotics.
    13. Known history of infection with human immunodeficiency virus (HIV).
    14. Active hepatitis B or C infection. Patients who are positive for hepatitis B core antibody and negative for hepatitis B surface antigen must have a negative
    polymerase chain reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen positive or PCR positive will be excluded.
    15. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
    16. Current life-threatening illness, medical condition, or organ-system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety or put the study at risk.
    17. Requirement for anticoagulation with warfarin.
    18. Requirement for treatment with a strong CYP3A4/5 inhibitor.
    E.5 End points
    E.5.1Primary end point(s)
    PFS as assessed by IRC review according to IWCLL criteria (Hallek 2008) with modification for treatment-related lymphocytosis (Hallek 2012).
    E.5.1.1Timepoint(s) of evaluation of this end point
    (a) after all enrolled patients have received a minimum of 12 months of treatment and/or follow-up, and (b) either 81 confirmed progression or death events have occurred or 15 months have elapsed after the last patient was randomized -whichever comes first.
    E.5.2Secondary end point(s)
    Efficacy
    • ORR defined as the proportion of patients who achieve CR, CRi, nPR, or (PR) per IWCLL 2008 criteria over the course of the study as assessed by the IRC
    • Rate of MRD-negative CRs
    • OS
    • Change from baseline FACiT-Fatigue score
    • Rate of hematological improvement

    Safety
    • Incidence of AEs and changes in laboratory variables, vital signs, and ECG
    In addition, Event-Free Survival (EFS) will be included as a secondary endpoint in response to a European Medicines Agency (EMA) recommendation, where progressive disease (PD), death and non-response at 4 months after randomization are defined as events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    (a) after all enrolled patients have received a minimum of 12 months of treatment and/or follow-up, and (b) either 81 confirmed progression or death events have occurred or 15 months have elapsed after the last patient was randomized—whichever comes first.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) 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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Canada
    China
    Czech Republic
    Germany
    Ireland
    Israel
    Italy
    New Zealand
    Poland
    Russian Federation
    Spain
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The database will be locked at the point that all enrolled patients have had the opportunity to complete at least 12 months of
    treatment and/or follow-up and either (a) 81 progression or death
    events have been observed or (b) 15 months have elapsed after the last patient is randomized— whichever occurs first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 272
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 272
    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)
    Companion Study PCYC-1116-CA, an extension study for patients with CLL and SLL participating in Study PCYC-1115-CA, will be made available for long-term follow-up and/or second-line therapy for patients who experience IRC-confirmed disease progression, or at the time of PCYC-1115-CA study closure.
    All the other patients be ineligible for Study PCYC-1116-CA and will return to normal 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 Decision2013-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-04
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