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    Summary
    EudraCT Number:2011-001867-28
    Sponsor's Protocol Code Number:MEF4982g
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-26
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-001867-28
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF MEGF0444A DOSED TO PROGRESSION IN COMBINATION WITH BEVACIZUMAB AND FOLFOX IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study comparing the effects of chemotherapy plus Avastin to chemotherapy plus Avastin plus a new drug (MEGF0444A) in patients with colorectal cancer that has spread to other parts of the body, who have not received chemotherapy before

    A.4.1Sponsor's protocol code numberMEF4982g
    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 SponsorGenentech, Inc
    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 supportGenentech, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech, Inc.
    B.5.2Functional name of contact pointKP Smith
    B.5.3 Address:
    B.5.3.1Street AddressGenentech, Inc.
    B.5.3.2Town/ city1 DNA Way, South San Francisco, California
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number001650467 8863
    B.5.5Fax number001 650467 2214
    B.5.6E-mailsmith.kenneth@gene.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 nameMEGF0444A
    D.3.2Product code MEGF0444A
    D.3.4Pharmaceutical form Solution for injection
    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 INNrecombinant antibody
    D.3.9.2Current sponsor codeMEGF0444A
    D.3.9.3Other descriptive nameAnti-EGFL7, aEGFL7, hu18F7, h18F7.v6K, anti-VEMF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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: 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 Avastin
    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 nameAvastin (Bevacizumab)
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    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 5-Fluorouracil
    D.2.1.1.2Name of the Marketing Authorisation holderGRY-Pharma GmbH; medac
    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.3.1Product nameFluorouracil Injection, 50 mg / ml
    D.3.2Product code 5-FU
    D.3.4Pharmaceutical form Solution for injection
    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 INNFLUOROURACIL
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code5-FU
    D.3.9.3Other descriptive name5-FLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer that has spread to other parts of the body for those patients that have not received chemotherapy before

    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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 estimate the efficacy of MEGF0444A used in combination with FOLFOX + bevacizumab therapy in patients with previously untreated mCRC, as measured by progression-free survival (PFS)
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of MEGF0444A in combination with FOLFOX + bevacizumab therapy in patients with previously untreated mCRC
    • To estimate the efficacy of MEGF0444A in combination with FOLFOX + bevacizumab therapy in patients with previously untreated metastatic CRC, as measured by overall survival (OS), objective response
    rate (ORR), and duration of objective response and OS
    • To characterize the PK of MEGF0444A and FOLFOX when combined with bevacizumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DNA REPOSITORY SUBSTUDY IN ASSOCIATION
    WITH MEGF0444A STUDY MEF4982g
    Protocol number: MEF4982g (DNA Substudy)
    Protocol version: Final
    Protocol date: 20 June 2011

    The primary objective of this study is to perform exploratory analyses to generate hypotheses identifying genes associated with treatment response, toxicity, or disease risk. If such genetic hypotheses are identified, they may be tested in future clinical studies within this therapeutic area.
    E.3Principal inclusion criteria
    a. Disease-Specific Inclusion Criteria
    • Histologically or cytologically confirmed CRC not amenable to potentially curative resection with at least one measurable metastatic lesion, as defined by RECIST v1.1 (see Appendix C)
    Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides with an associated pathology report must be confirmed to be available (located at the site or sent to the site from a referring institution) at any time prior to study entry

    b. General Inclusion Criteria
    • Signed informed consent form
    • Age ≥ 18 years
    • ECOG performance status of 0 or 1 (see Appendix E)
    • Able to comply with the protocol
    • Adequate hematologic and end organ function, defined by the following
    laboratory results obtained within 14 days prior to the first study treatment:
    Absolute neutrophil count (ANC) ≥ 1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to randomization)
    Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to randomization)
    Hemoglobin ≥ 9.0 g/dL
    Patients may be transfused or receive erythropoietic treatment to meet this criterion.
    AST and ALT ≤ 3 × ULN, and alkaline phosphatase ≤ 2.5 × ULN, with the following exceptions:
    Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN
    Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 × ULN
    Serum bilirubin ≤ 1.5× ULN
    Patients with known Gilbert disease who have serum bilirubin level ≤ 3× ULN may be enrolled
    International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN within 7 days prior to randomization
    Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min on the basis of the Cockroft−Gault glomerular filtration rate estimation:
    (140 − age) × (weight in kg) × (0.85 if female) / 72 × (serum creatinine in mg/dL)
    Urine dipstick for proteinuria < 2+.
    Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours.
    • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for 6 months after the last dose of bevacizumab or MEGF0444A/placebo
    • Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women < 2 years after the onset of menopause
    • Willingness and capability to be accessible for study follow-up
    E.4Principal exclusion criteria
    a. Disease-Specific Exclusions
    • Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine
    kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy or
    investigational therapy) before Day 1 of Cycle 1 for treatment of mCRC
    Patients who received prior adjuvant systemic therapy or radiotherapy for
    CRC are not excluded if the time interval from last administration of adjuvant therapy until disease progression is > 12 months.
    Patients who receive hormone-replacement therapy or oral contraceptives are not excluded
    Patients who received herbal therapy intended as anti-cancer therapy ≥ 2 weeks prior to Day 1 are not excluded
    b. General Medical Exclusions
    •Malignancies other than CRC within 5 years prior to randomization, except for those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
    •Radiotherapy to any site for any reason within 28 days prior to Day 1 of Cycle 1
    Palliative radiotherapy to bone lesions > 7 days prior to Day 1 of Cycle 1 is allowed
    •Clinically detectable (by physical exam) third-space fluid collections (e.g., ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
    •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to Day 1 of Cycle 1
    •Lactating women
    •Known hypersensitivity to Chinese hamster ovary cell products, recombinant human antibodies or any of the chemotherapy agents to be used in this study
    •Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures
    •Clinically suspected or confirmed CNS metastases or carcinomatous meningitis
    •Active infection requiring IV antibiotics
    •Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of ≤ 10 mg/day prednisone
    •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
    •Sensory peripheral neuropathy ≥ Grade 2
    c. Bevacizumab-Specific Exclusions
    •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of bevacizumab or an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
    •Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
    Anti-hypertensive therapy to achieve these parameters is allowable.
    •Prior history of hypertensive crisis or hypertensive encephalopathy
    •NYHA Class II or greater CHF (see Appendix F)
    •History of myocardial infarction or unstable angina within 6 months prior to Day 1
    •History of stroke or transient ischemic attack (TIA) within 6 months prior to Day 1
    •Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
    •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
    •Current or recent (within 10 days of first dose of study treatment) use of aspirin (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel and cilostazol
    •Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose
    Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an international normalized ratio (INR) < 1.5 ULN and activated partial thromboplastin time (aPTT) is within normal limits within 1 week of Day 1
    Prophylactic use of low molecular-weight heparin (i.e., enoxaprin [40 mg QD]) is allowed
    •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
    •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
    •History of abdominal or tracheo-oesophageal fistula or GI perforation within 6 months prior to Day 1
    •Clinical signs or symptoms of GI obstruction or that requires routine parenteral hydration, parenteral nutrition or tube feeding
    •Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
    •Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
    d. 5-FU-Specific Exclusion
    • Please refer to protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is progression-free survival (PFS) defined as the time from randomization to the first occurrence of documented disease progression or death from any cause on study, whichever occurs earlier, determined by the investigator. Death on study is defined as death from any cause within 30 days of the last study treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data for patients without disease progression or death on study will be censored at the time of the last tumor assessment (or, if no tumor assessments were performed after the baseline visit, at the time of randomization plus 1 day).
    E.5.2Secondary end point(s)
    Objective Response, Duration of Objective Response and Overall Survival.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Objective Response - Objective response is defined as a complete or partial response by RECIST v1.1 determined on two consecutive occasions ≥ 4 weeks apart.

    Duration of Objective Response. For patients with an objective response, duration of objective response is defined as the time from the initial response to disease progression or death from any cause on study.

    Overall Survival - For patients who have not died, overall survival will be censored at the date of last contact. Analysis methods are the same as those described for PFS
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Poland
    Spain
    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
    Last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1Number of subjects for this age range: 0
    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: 108
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 120
    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 Decision2011-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-24
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