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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-000379-15
    Sponsor's Protocol Code Number:192024-057 Amendment 2
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-000379-15
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Bimatoprost Solution 0.03%, 0.1%, and 0.3% Compared with Vehicle in Men with Androgenic Alopecia with an Open-label Active Comparator (Minoxidil 5%) Group
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to study the safety and effectiveness of three different strengths (0.03%, 0.1% and 0.3%) bimatoprost solution compared to a solution containing no active ingredient (placebo) and an already licenced product (minoxidil 5%) in the treatment of male-pattern baldness (androgenic alopecia).
    A.4.1Sponsor's protocol code number192024-057 Amendment 2
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01325337
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAllergan Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointAllergan Ltd. EU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailml-eu_reg_affairs@allergan.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 nameBimatoprost solution 0.03%
    D.3.2Product code 10074X
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeAGN-192024
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.03
    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 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 nameBimatoprost solution 0.1%
    D.3.2Product code 10075X
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeAGN-192024
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBimatoprost solution 0.3%
    D.3.2Product code 10076X
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeAGN-192024
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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: 4
    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 Regaine Manner, 5% Losung
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Consumer Healthcare GmbH
    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 Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMINOXIDIL
    D.3.9.1CAS number 38304-91-5
    D.3.9.4EV Substance CodeSUB08982MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Androgenic alopecia in men
    E.1.1.1Medical condition in easily understood language
    Male-pattern baldness
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068558
    E.1.2Term Androgenic alopecia
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the safety and efficacy of bimatoprost solution 0.03%, 0.1%, and 0.3% once-daily topical application compared with vehicle and minoxidil in increasing scalp hair growth in male subjects with AGA.
    E.2.2Secondary objectives of the trial
    None.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following are requirements for entry into the study:
    1. Males 18 to 49 years of age with mild to moderate AGA of the vertex area of the scalp (modified Norwood Hamilton scale classification of IIIv, IV, or V) who report scalp hair growth/coverageloss ongoing for at least 1 year
    2. Written informed consent has been obtained
    3. Written documentation has been obtained in accordance with the relevant country and
    local privacy requirements, where applicable (eg, Written Authorization for Use and
    Release of Health and Research Study Information [US sites] and written Data
    Protection consent [EU sites])
    4. Standardized global photographs of the scalp at the screening visit of acceptable quality for assessment, as verified by Canfield Scientific, Inc. (Canfield)
    5. Ability to follow study instructions and willingness to complete all required procedures and visits, including micro-dot tattoo and macro photography procedures
    6. Hair length in non-balding areas ≥ 2 cm (3/4 inch) around the vertex region of scalp and willing to maintain the same hair style, approximate length, and hair color throughout the duration of the study
    E.4Principal exclusion criteria
    The following are criteria for exclusion from participating in the study:
    1. An uncontrolled systemic disease
    2. Subjects with a history of significant cardiovascular disease, family history of long QT syndrome, or a clinically significant ECG abnormality at the screening visit.
    3. History or current evidence of drug or alcohol abuse within 12 months prior to study entry
    4. Subjects known to be HIV positive
    5. Subjects with sensitive, irritated, or abraded scalp area
    6. Subjects with global scalp hair thinning, including occipital areas
    7. Subjects with any known scarring, disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could prevent hair growth or produce abnormal hair (for example, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, genetic disorders)
    8. Subjects who have received hair transplants or had scalp reductions
    9. Concurrent use of hair weavings, hair extensions, or wigs or within 3 months prior to study entry
    10. Concurrent use of topical steroidal or nonsteroidal anti-inflammatory drugs applied to the scalp, or within 4 weeks prior to study entry; inhaled glucocorticoids are allowed
    11. Concurrent treatment or within 6 months prior to study entry of any of the following:
    a. Prostaglandins or prostamides
    b. Minoxidil (oral or topical)
    c. Drugs with anti-androgenic properties (for example, cyproterone acetate, spironolactone, flutamide, bicalutamide, cimetidine, oral ketoconazole)
    d. Topical or oral estrogen, progesterone, tamoxifen
    12. Concurrent systemic treatment that may affect hair growth (for example, 5 alpha reductase inhibitors such as finasteride and dutasteride, cytotoxic agents, cyclosporine, diazoxide, anabolic steroids) or within 12 months prior to study entry
    13. Known allergy or sensitivity to the study medication or its components
    14. Known allergy, sensitivity, or contraindication to minoxidil
    15. Known allergy or sensitivity to tattoo ink
    16. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to study entry
    17. Subject has a condition or is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    Target Area Hair Count
    The co-primary efficacy measure will be the Target Area Hair Count (TAHC) as measured in terminal hairs/cm2 using digital image analysis.
    The total number of terminal hairs (hair ≥ 30 microns in width) is calculated from macro photographs for each visit. The target area used to count TAHC is a 1 cm2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a micro-dot tattoo to ensure the same target site is reproduced at each visit.
    The co-primary efficacy endpoint is defined as change from baseline in TAHC (terminal hairs/cm2) at month 6 using digital image analysis.

    Subject’s Assessment of Change of Scalp Hair Growth/Coverage
    Another co-primary efficacy measure will be the subject’s assessment of change of scalp hair growth as measured by the Subject Self Assessment (SSA) question 1 using a 7 point scale.
    The SSA question 1 is a subject-rated assessment of their change in scalp hair growth using an ordinal, 7-point scale. The subject uses a standardized global photograph of their own scalp at the start of the study (baseline status) side-by-side with a standardized global photograph of their own scalp at the current visit to give a comparative score at each visit after baseline. The scale point ranges from -3 to +3, where -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = remained the same, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased.

    The co-primary efficacy endpoint is defined as the distribution of SSA question 1 scores at month 6 using a 7-point scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months.
    E.5.2Secondary end point(s)
    Secondary efficacy measures include:
    • Investigator’s assessment of change of scalp hair growth as measured by Investigator Global Assessment (IGA).
    The IGA is an investigator-graded live assessment using an ordinal, 7-point scale. The investigator uses a standardized global photograph of the scalp at the start of the study (baseline) as a reference to give a comparative score at each visit. The scale points range from -3 to +3, where -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = remained the same, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased.
    • Global Panel Review (GPR).
    An independent panel of 3-5 dermatologists will evaluate a subject’s scalp hair in a blinded manner based on evaluation of standardized global photographs. In contrast to IGA, there is no live assessment; all assessments are performed from photographs alone. The panel is blinded to subjects’ treatment and is given a set of photographs for each subject and each visit. The baseline photo is identified and remaining visit photos are given a comparative score. The GPR uses anis a panel-reviewed, ordinal, 7-point scale. The scale points range from -3 to +3, where -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = remained the same, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased.
    • Target Area Hair Width (TAHW) in µm/cm2 as measured using digital image analysis. The width of each terminal hair (hair ≥ 30 microns in width) is calculated from macro photographs resulting in a summary measurement for each visit. The target area used to calculate TAHW is a 1cm2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a micro-dot tattoo to ensure the same target site is reproduced at each visit.
    • Target Area Hair Darkness (TAHD) in intensity units as measured using digital image analysis.

    The secondary efficacy endpoints include: 1) the distribution of IGA scores at month 6 using a 7-point scale, 2) the distribution of GRP scores at month 6 using a 7-point scale, 3) change from baseline in TAHW (µm/cm2) at month 6 using digital image analysis, and 4) change from baseline in TAHD (intensity units) at month 6 using digital image analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    PK sampling is undertaken on US subjects only.
    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 Yes
    E.8.1.7.1Other trial design description
    There is an open-label cohort.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Minoxidil 5% (PR4) is an open-label comparator.
    E.8.2.4Number of treatment arms in the trial5
    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 concerned9
    E.8.5The trial involves multiple Member States No
    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
    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
    LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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: 300
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 300
    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)
    The 8-week follow-up period following the treatment cycle allows for suitable post-treatment patient safety monitoring. End of study for each individual will occur after all planned study procedures have been completed. Patients may have follow-up safety assessments after the end of study if required due to significant clinical or laboratory test abnormalities, until the time at which the abnormality is considered resolved or clinically stable.
    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 Decision2011-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-10
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