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    Summary
    EudraCT Number:2009-011504-36
    Sponsor's Protocol Code Number:AL0906rP
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2009-011504-36
    A.3Full title of the trial
    Randomised double blind placebo controlled pivotal study to evaluate efficacy and safety of rPhleum in adult and adolescent patients suffering from rhinoconjunctivitis +/- controlled Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to demonstrate the efficacy and tolerability of rPhleum for treatment
    of patients with an allergic rhinoconjunctivitis +/- asthma
    A.3.2Name or abbreviated title of the trial where available
    2nd pivotal rPhleum
    A.4.1Sponsor's protocol code numberAL0906rP
    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 SponsorAllergopharma Joachim Ganzer KG
    B.1.3.4CountryGermany
    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 supportAllergopharma Joachim Ganzer KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergopharma Joachim Ganzer KG
    B.5.2Functional name of contact pointKaren Gessner
    B.5.3 Address:
    B.5.3.1Street AddressHermann-Koerner-Strasse 52
    B.5.3.2Town/ cityReinbek
    B.5.3.3Post code21465
    B.5.3.4CountryGermany
    B.5.4Telephone number0049-40-72765-392
    B.5.5Fax number0049-40-72765-600
    B.5.6E-mailkaren.gessner@allergopharma.de
    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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor coderPhleum
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.78
    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) Yes
    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 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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namerPhleum
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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) Yes
    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 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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor coderPhleum
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(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 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) Yes
    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: 4
    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 nameCocktail of recombinant major allergens of Phleum pratense
    D.3.2Product code rPhleum
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namerPhleum
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ICD classification code: J45.0 and J 30.1
    Rhiniconjunctivitis +/- asthma bronchiale

    E.1.1.1Medical condition in easily understood language
    Hayfever
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 aim of this clinical trial is to prove the hypothesis that the recombinant allergen preparation rPhleum is suitable for an efficacious SCIT in grass pollen allergic patients and that the trial preparation is sufficient to suppress allergic symptoms caused by natural grass pollen exposure. The trial medication will be tested versus placebo in a total of 228 subjects.
    E.2.2Secondary objectives of the trial
    1)Changes of AUC of the medication-adjusted Rhinoconjunctivitis Symptom Score (ma RC-SS) after 1 and 3 years.
    2)Changes of AUC of the Rhinoconjunctivitis Symptom-Medication-Score (RC-SMS) after 1, 2 and 3 years.
    3)Changes of AUC of the rhinoconjunctivitis symptom score after 1, 2 and 3 years.
    4)Changes of AUC of the rhinoconjunctivitis medication score after 1, 2 and 3 years.
    5)Changes of AUC of the total Symptom-Medication-Score of rhinoconjunctivitis and asthma (SMS) after 1, 2 and 3 years.
    6)Changes of AUC of the total symptom score after 1, 2 and 3 years.
    7)Changes of total medication score after 1, 2 and 3 years.
    8)Immunologic changes: specific IgGand IgG4.
    9)Improvement in specific conjunctival provocation.
    10)Well days based on RC-SMS (no medication intake and maximum 2 score points).
    11)Response status in terms of 40% improvement for the primary variable for an individual trial subject as compared to baseline.
    12)Change of EQ-5D (before vs. after treatment).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the subject given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the subject and any other trial-related activity performed with trial specific diagnostics or with trial medication)
    2. Is the subject a legally competent male or female outpatient?
    3. Is the subject aged 12 - 65 year?
    4. Does the subject suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma (controlled, acc. to GINA 2006) caused by grass pollen documented by
    o skin prick test wheal for grass pollen ≥ 5mm in diameter and
    o histamine (1,0% histaminedihydrochloride) wheal ≥ 3mm and
    o NaCl control reaction < 3mm and
    o EAST result (inhouse Allergopharma) ≥ 1.5kU/L to grass pollens and
    o proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens and
    o main discomfort in the months:
    - May, June, July and August of the year for Germany, Poland, United Kingdom and France
    - April, May, June, July and August of the year for Spain
    o Does the subject with bronchial asthma at entry have a confirmed diagnosis of asthma and does his asthma has been classified as “controlled” according to GINA guidelines (version 2006) with PEF or FEV1 at least 80% of predicted normal?

    5. Has the subject been treated with anti-allergic medications for at least 2 years prior to enrolment? (Subjects with perennial and continuously treated asthma have to be excluded, see “exclusion criteria” below.)
    6. For female patients: Does the subject use effective contraception and does she have a negative pregnancy test result? (Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectibles, combined or oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. No pharmacological interactions are known for hormonal contraceptives and specific immunotherapeutic preparations.)

    At the beginning of the treatment phase (November 2010):
    7. Does the subject suffer from rhinoconjunctivitis symptoms documented in the subjects diary during the baseline season?
    8. Does the subject have demonstrated a symptom-score of at least 4 per day
    during the week following the peak pollen count in the baseline season?
    E.4Principal exclusion criteria
    -unable to understand and comply with the requirements of the trial, as judged by the investigator
    -currently participating in any other trial or has the subject participated in any other trial within 30 days before inclusion in this trial
    -involved in the planning and conduct of the trial
    -an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites
    -any relationship of dependence with the sponsor and/or with the investigator
    -previously enrolled or randomised to treatment in the present trial
    -mentally disabled
    -institutionalised due to an official or judicial order

    For females with childbearing potential :
    -a positive pregnancy test before the baseline phase
    -use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator
    -pregnant or within the lactation period
    -seeking to become pregnant
    Immunotherapy criteria:
    -undergone previous specific immunotherapy with grass pollen allergens in any formulation
    -currently undergoing any sort of immunotherapy
    -ever undergone specific immunotherapy with unknown allergen or an unsuccessful immunotherapy
    -For allergens which interfere with the grass pollen season for all participating countries: Plantain, nettle, mugwort, alternaria alternata, Dermatophagoides farinae, Dermatophagoides pteronyssinus
    Additionally the following allergens will be tested in the following countries:
    Spain: olive tree, cat epithelia, dog epithelia
    UK: aspergillus, cat epithelia, dog epithelia
    PL: cat epithelia, dog epithelia
    D: cat epithelia, dog epithelia
    •skin prick test a wheal diameter of respective interfering allergen ≥ wheal diameter of grass pollen allergen or
    •Sensitisation to respective interfering allergen as determined by serum EAST ≥ sensitisation to grass pollen? Additionally for France: a sensitisation to cat or dog allergens as determined by serum EAST ≥ 0,35kU/l
    -suffer from any clinically relevant perennial allergies (e.g. cat, mite) and clinical relevance can not be excluded

    Disease and health status:
    -show a total IgE of > 2000kU/l
    -suffer from clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons
    -PEF or FEV1 < 80% of predicted normal (ECSC)
    -uncontrolled or partly controlled asthma according to GINA guidelines (version 2006)
    -suffer from perennial and continuously treated asthma
    -suffer from rhinoconjunctival atopy symptoms for 20 years or longer
    -suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases
    -suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies
    -suffer from severe psychiatric and psychological disorders including impairment of cooperation
    -suffer from recurrent seizures?
    -suffer from irreversible secondary alterations of the reactive organ
    -any physiological and laboratory variables within/outside normal limits and as reported to be greater than Grade 1 changes according to the FDA Guidance for Industry an/or normal for population
    -treated with beta-blockers (locally and systemically)
    -any contraindication for use of adrenalin
    -completed or has an ongoing treatment with anti-IgE-antibody
    -completed or has an ongoing long-term treatment with tranquilizer or other psychoactive drugs
    -treated for allergy or asthma according to severity of symptoms with other than the following medication during the pollen season: Levocabastine nasal spray/eye drops, Loratadine/Cetirizine tablets, Salbutamol, inhaled corticosteroids up to a dose of 500µg/d BDP or equivalents, and exacerbation treatment with a short course of oral corticosteroids (Treatment with other medication must be stopped 2 weeks prior to start of the grass pollen season.)
    -using any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the treatment phase of the trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this trial is the change of the area under the curve (AUC) of the medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) from the baseline season to the season after 2 years of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    see section E.5.1
    E.5.2Secondary end point(s)
    1) Changes of AUC of the medication-adjusted Rhinoconjunctivitis Symptom Score (ma RC-SS) after 1 and 3 years.
    2) Changes of AUC of the Rhinoconjunctivitis Symptom-Medication-Score (RC-SMS) after 1, 2 and 3 years.
    3) Changes of AUC of the rhinoconjunctivitis symptom score after 1, 2 and 3 years.
    4) Changes of AUC of the rhinoconjunctivitis medication score after 1, 2 and 3 years.
    5) Changes of AUC of the total Symptom-Medication-Score of rhinoconjunctivitis and asthma (SMS) after 1, 2 and 3 years.
    6) Changes of AUC of the total symptom score after 1, 2 and 3 years.
    7) Changes of total medication score after 1, 2 and 3 years.
    8) Immunologic changes: specific IgGand IgG4.
    9) Improvement in specific conjunctival provocation.
    10) Well days based on RC-SMS (no medication intake and maximum 2 score points).
    11) Response status in terms of 40% improvement for the primary variable for an individual trial subject as compared to baseline.
    12) Change of EQ-5D (before vs. after treatment).
    E.5.2.1Timepoint(s) of evaluation of this end point
    see section E.5.2
    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 No
    E.6.7Pharmacodynamic Yes
    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 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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of open-label treatment phase
    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 months11
    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 months11
    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 Yes
    F.1.1Number of subjects for this age range: 228
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 228
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 228
    F.1.3Elderly (>=65 years) No
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 228
    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)
    Patients will be followed up according to GCP, ICH and WHO-Guidelines.
    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 Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-17
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