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    Summary
    EudraCT Number:2010-022766-27
    Sponsor's Protocol Code Number:B3041001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-022766-27
    A.3Full title of the trial
    A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis
    A.4.1Sponsor's protocol code numberB3041001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01240915
    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 SponsorPfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
    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 supportPfizer Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number001303739 1119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 nameMultiStem
    D.3.2Product code PF-05285401
    D.3.4Pharmaceutical form Suspension 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.3.9.2Current sponsor codePF-05285401
    D.3.9.3Other descriptive nameMultistem
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 nameMultiStem
    D.3.2Product code PF-05285401
    D.3.4Pharmaceutical form Suspension 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.3.9.2Current sponsor codePF-05285401
    D.3.9.3Other descriptive nameMultistem
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 Yes
    D.2.1.1.1Trade name Promiten
    D.2.1.1.2Name of the Marketing Authorisation holderMeda A/S
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 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.3.9.3Other descriptive nameDEXTRAN 1 FOR INJECTION
    D.3.9.4EV Substance CodeSUB11894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis is a type of Inflammatory Bowel Disease (IBD), which involves inflammation of all or part of the colon.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 safety and tolerability of intravenous doses of MultiStem in moderate-to-severe ulcerative colitis.

    • To study the efficacy of a single intravenous dose of MultiStem in moderate-to-severe ulcerative colitis measured by an effect on endoscopic and rectal bleeding scores.
    E.2.2Secondary objectives of the trial
    • To study the effect of a single intravenous dose of MultiStem on disease severity measured by total and partial Mayo score.

    • To study the effect of repeat intravenous dose of MultiStem on disease measured by partial Mayo score and by rectal bleeding.

    • To study the effect of intravenous doses of MultiStem on fecal calprotectin and C-reactive protein (CRP) levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. The selection of patients is based on the data available from Screening. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle guidelines and other study procedures.
    3. Subject must be at least 18 years of age.
    4. Males and females with a documented diagnosis (endoscopic or radiographic) of UC ≥6 months prior to screening.
    5. For Cohort 1 and 2 only: Active moderate-to-severe UC defined as Mayo score of ≥6 and <11.
    6. For Cohort 3 only: Active moderate-to-severe UC defined as Mayo score of ≥6.
    7. Modified Baron endoscopic score of ≥2 determined within 21 days of first dosing for Cohort 1 and within 7 days of first dosing for Cohorts 2 and 3 (flexible sigmoidoscopy unless surveillance colonoscopy clinically indicated).
    8. Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab.
    9. Subjects currently receiving the following treatment regimens for UC are eligible providing they are on stable dose for designated period of time:
    a. 5-ASA or sulfasalazine stable dose for at least 3 weeks prior to Day 1 and during the study treatment period.
    b. Corticosteroids or equivalent at a stable dose for at least 2 weeks prior to Day 1 study visit (Prednisolone ≤25 mg/day, or equivalent). NOTE: Tapering of corticosteroids or equivalent may only commence at Week 8 (see “Concomitant Medications” section of the protocol).
    c. Antibiotics (eg, metronidazole, rifaximin) stable dose for at least 2 weeks prior to Day 1 study visit and during the study treatment period ie, up to Week 8.
    d. Rectally administered formulation of corticosteroids or 5-ASA stable dose for at least 2 weeks prior to Day 1 study visit and during the study treatment period i.e. up to Week 8.
    e. Methotrexate (up to 15 mg/week subcutaneously), azathioprine (up to 2.5 mg/kg/day) and 6-mercaptopurine (up to 1.5 mg/kg/day) stable for at least 2 months prior to Day 1 study visit and during the study treatment period i.e. up to Week 8. NOTE: excluded medications include anti-TNF therapies used within 8 weeks of Day 1 study visit or cyclosporine, mycophenolate, or tacrolimus used within 4 weeks of Day 1 study visit as described in the exclusion criteria.
    10. Subjects willing to use double contraception during the study
    treatment period and until completion of follow-up procedures ie, Week
    52: (a) If the subject is a sexually active woman of childbearing
    potential, she and her male partner are required to simultaneously use 2
    effective contraceptive methods as listed in Section 4.4.2 of the protocol.
    Female subjects who wish to use non-hormonal contraception must have
    done so for at least 14 days prior to the Day 1 study visit. (b) Nonvasectomized
    males with female partners of child bearing potential must
    be willing to use a condom in addition to having their female partner use
    another form of contraception as listed in Section 4.4.2. of the protocol.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2. Abnormal organ and marrow function as defined: (a) leukocytes <4,000/µL. (b) Platelets <150,000/µL. (c) AST (SGOT) or ALT (SGPT) >3x institutional upper limit of normal. (d) Bilirubin >upper institutional limit of normal. (e) Creatinine >1.2 mg/dL.
    3. Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn’s disease, including Crohn’s enterocolitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis as well as microscopic colitis.
    4. Subjects with UC, which is confined to a proctitis defined as inflammation limited to less than 15 cm from the anal verge on a flexible sigmoidoscopy.
    5. Subjects who meet Truelove-Witts criteria for severe UC. Diarrhea >6 times/day, bloody and any one of the items: (a) Hemoglobin 75% or below of normal value. (b) Evening temperature >37.5◦C. (c) Pulse rate >90 beats/min. (d) ESR >30 mm/h.
    6. Subjects who have received i.v. steroids or TPN or have been hospitalized due to UC within 3 weeks prior to screening.
    7. Subjects displaying clinical signs of toxic megacolon, ischemic colitis or fulminant colitis.
    8. Known allergies to bovine or porcine products, dextran or H1 blockers.
    9. 9. Known intolerance to corticosteroids.
    10. Subjects who have previously participated in any study of an allogeneic cell therapy, with the exception of erythrocyte transfusions.
    11. Subjects who have received any investigational drug or device within 3 months (or as determined by the local requirement, whichever is longer) prior to Day 1 study visit.
    12. History of symptomatic obstructive strictures, an ostomy, extensive bowel resection
    (>100 cm) or short bowel syndrome.
    13. History of bowel surgery within 6 months prior to Day 1 study visit.
    14. Subject who have had surgery as a treatment for UC or, in the opinion of the investigator, are likely to require surgery within 16 weeks of informed consent.
    15. Subjects diagnosed with primary sclerosing cholangitis.
    16. Subjects with active inflammatory eye disease.
    17. Subjects with spondylarthropathy and active musculoskeletal manifestation.
    18. Subjects with active pyoderma gangrenosum or erythema nodosum lesions.
    19. Subjects with clinically significant pulmonary disease (eg, subjects with COPD GOLD stage III or IV).
    20. Subjects with NYHA class IV congestive heart failure.
    21. Subjects with active systemic or severe local infections.
    22. Fecal culture indicating presence of pathogenic infection; positive C. difficile toxin, or positive stool ova and parasite exam.
    23. Subjects likely to require any type of surgery within 16 weeks from informed consent.
    24. Known collection or abscess on MRI of the pelvis.
    25. Pregnant or lactating women.
    26. History of alcohol or drug abuse with less than 6 months of abstinence prior to Day 1 study visit.
    27. Screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results.
    28. Subjects with a temperature of 38◦C (100.4◦F) or higher at screening.
    29. Subjects with malignancies or with a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
    30. Significant trauma or major surgery within 4 weeks of screening visit.
    31. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
    32. Subjects receiving or who are expected to receive concomitant medications in the list of prohibited medications. (a) Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit. (b) Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.
    33.Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
    34.Subjects participating in another ongoing clinical study.
    35. Any other condition which would make the subject unsuitable for inclusion in the study.
    36. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    37.Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence and severity of adverse events (at Weeks, 4, 8, 12 and 16).

    - Change from baseline of endoscopic score at Week 8 as measured by modified Baron score.

    - Change from baseline of Mayo rectal bleeding sub-score at Week 4.

    - Change from baseline of Mayo rectal bleeding sub-score at Week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, 12 and 16.
    E.5.2Secondary end point(s)
    • Change from baseline of Mayo rectal bleeding sub-score at Weeks 12 and 16.
    • Changes in laboratory measurements of safety and vital signs (at Weeks 4, 8, 12, and 16).
    • Changes from baseline at Weeks 4, 8, 12 and 16 in the following biomarker levels: fecal calprotectin, CRP.
    • Proportion of subjects with a Mayo rectal bleeding sub-score equal 0 at Weeks 4, 8, 12 and 16.
    • Proportion of subjects in endoscopic remission at Week 8 (defined as subjects with a modified Baron endoscopic score equal 0).
    • Proportions of subjects in clinical remission at Week 8 (defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point).
    • Proportions of subjects with a decrease from baseline of at least one point in Mayo rectal bleeding sub-score at Weeks 4, 8, 12 and 16.
    • Proportion of subjects with an endoscopic response at Week 8 (defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points).
    • Proportion of subjects with a clinical response at Week 8 (defined as a decrease in total Mayo score from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point or an absolute sub-score for rectal bleeding of 0 or 1).
    • Changes from baseline in total Mayo score at Week 8.
    • Changes from baseline in partial Mayo score at Weeks 4, 8, 12 and 16.
    • Patient-reported rectal bleeding scores, to be modeled longitudinally up to and including Week 16.
    • Changes in biopsy histology score at Week 8 (measured by Riley Index).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, 12 and 16.
    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 Yes
    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 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) 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 EEA26
    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
    Belgium
    Canada
    Germany
    Hungary
    Italy
    Poland
    Slovakia
    Sweden
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    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 months7
    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: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 128
    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)
    Normal treatment of the condition
    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 Decision2012-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-19
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