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    Summary
    EudraCT Number:2010-020558-33
    Sponsor's Protocol Code Number:997HA301
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-25
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2010-020558-33
    A.3Full title of the trial
    A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study involving people with severe haemophilia A to look at how safe an experimental replacement factor VIII protein (known as rFVIIIFc) is to take and how well it works to prevent and stop bleeds.
    A.3.2Name or abbreviated title of the trial where available
    A-LONG
    A.4.1Sponsor's protocol code number997HA301
    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 SponsorBiogen Idec Hemophilia, 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 supportBiogen Idec Hemophilia, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Hemophilia, Inc.
    B.5.2Functional name of contact pointHaemophilia Contact
    B.5.3 Address:
    B.5.3.1Street Address9 Fourth Avenue
    B.5.3.2Town/ cityWaltham, MA
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.6E-mailCTAhaemophiliacontact@biogenidec.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe hemophilia A - defined as <1 IU/dL (<1%) endogenous FVIII
    E.1.1.1Medical condition in easily understood language
    Severe Haemophilia A
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10056493
    E.1.2Term Haemophilia A without inhibitors
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10053753
    E.1.2Term Hemophilia A without inhibitors
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10018937
    E.1.2Term Haemophilia A
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10060612
    E.1.2Term Hemophilia A
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis, weekly, on-demand, and surgical treatment regimen
    • To evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1)
    • To evaluate the efficacy of rFVIIIFc administered as an on demand (Arm 3) and surgical treatment regimen
    E.2.2Secondary objectives of the trial
    • To characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate
    • To characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen; maintain hemostasis in a surgical setting; or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). Parental or guardian consent is required for subjects who are less than 18 years of age. Subjects less than 18 years of age should consent to the study providing a signed assent form if required by local regulations.
    2. Male, ≥12 years of age and weighing at least 40 kg
    3. Have severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII as determined by one-stage clotting assay from the central laboratory at the time of screening. If the screening result is ≥1%, then the severity of hemophilia A may be confirmed by documented historical evidence from a certified clinical laboratory demonstrating <1% FVIII:C as determined by the one-stage clotting assay from the medical record or from a documented genotype known to produce severe hemophilia A.
    4. Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 0 (Advate or rFVIIIFc). Fresh frozen plasma treatment must not be considered in the count for the documented exposure days.
    5. No measurable inhibitor activity using the Nijmegen-modified Bethesda assay (≥0.6 BU/mL is considered positive) in 2 consecutive samples and absence of clinical signs or symptoms of decreased response to FVIII administration. (First negative sample can be historical if obtained within 12 weeks prior to screening. The second confirmatory sample must in all cases be performed by the central laboratory using the Nijmegen modified Bethesda assay. If no recent sample is available, then 2 negative samples analyzed by the central laboratory at least 1 week apart should be obtained during screening). At least 96 hours washout of FVIII must have passed prior to collecting samples for inhibitor testing where possible (72 hours permitted during a repeat washout if the subject treats a bleeding episode prior to 96 hours on the first attempt).
    6. No history of FVIII inhibitor antibody formation (≥0.6 BU/mL using the Nijmegen-modified Bethesda assay; subjects with a maximum historical titer of 1.0 BU on no more than 1 occasion with the Classical Bethesda assay but at least 2 successive negative [<0.6 BU] results thereafter are also eligible)
    7. History of bleeding events and/or treatment with FVIII during the prior 12 weeks, as documented in the subjects’ medical records
    8. Willingness and ability of the subject or a surrogate (a caregiver or a family member ≥18 years of age) to complete training in the use of the study EPD and to use the EPD throughout the study
    9. For subjects entering Arm 1: Currently on a prophylaxis regimen at least 2 times per week with a FVIII product or on an on-demand regimen with ≥12 bleeding episodes in the 12 months prior to Day 0 (Advate or rFVIIIFc)
    10. For subjects entering Arm 2 or 3: Currently on an on-demand regimen with ≥12 bleeding \episodes in the 12 months prior to Day 0 (rFVIIIFc)
    The following inclusion criteria refer to tests by the central laboratory sampled at screening and reviewed prior to Day 0 (Advate or rFVIIIFc):
    11. Platelet count >100,000 cells/μL
    12. International normalized ratio (INR) ≤1.30, as defined by the testing laboratory’s normal range
    13. Immunocompetent: CD4 lymphocytes >200 mm3
    14. Viral load of <400 copies/mL, if human immunodeficiency virus (HIV) antibody positive
    E.4Principal exclusion criteria
    1. History of, or currently detectable inhibitor titer as defined by the central laboratory (family history of inhibitors will not exclude the subject)
    2. Other coagulation disorder(s) in addition to hemophilia A
    3. History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
    4. For the PK subgroup only: known hypersensitivity to mouse or hamster proteins
    5. Currently taking (or likely to require during the study) acetylsalicylic acid (ASA) or ibuprofen (other non-steroidal anti-inflammatory drugs are permitted)
    6. Concurrent systemic treatment with immunosuppressive drugs 12 weeks prior to Day 0 (Advate or rFVIIIFc). (Exceptions: ribavirin, treatment of hepatitis C virus [HCV] and HIV and/or systemic steroids [a total of 2 courses of pulse treatments within 7 days ≤1 mg/kg] and/or inhaled steroids)
    7. Major surgery within the previous 8 weeks
    8. Unable to enter accurate and timely information regarding injections and bleeding episodes into an EPD and without adequate parental/caregiver support to manage this (per the Investigator’s judgment)
    9. Unable or unwilling to refrain from taking additional prophylactic doses of rFVIII prior to sports activities or an increase in physical activity
    10. Current enrollment or enrollment within the past 30 days in any other clinical trial involving investigational drugs.
    11. Any concurrent clinically significant major disease or other unspecified reasons that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
    The following exclusion criteria refer to tests by the central laboratory sampled at screening and reviewed prior to Day 0 (Advate or rFVIIIFc):
    12. Abnormal renal function (serum creatinine >2.0 mg/dL)
    13. Serum alanine transaminase (ALT) or aspartate aminotransferase (AST) >5x upper limit of normal (ULN)
    14. Serum bilirubin >3x ULN
    E.5 End points
    E.5.1Primary end point(s)
    For Safety and Tolerability:
    • Clinically notable changes from baseline in physical examinations and vital signs
    • Incidence of AEs, including clinically significant abnormal laboratory values
    • Incidence of inhibitor development using the Nijmegen-modified Bethesda assay
    For Efficacy:
    • Annualized number of bleeding episodes (spontaneous and traumatic)
    • Primary PK parameters are the following assessments of FVIII activity: dose-corrected area under the curve (AUC/dose), half-life, MRT, clearance (CL), and incremental recovery based on the one-stage clotting assay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through-out treatment period.
    E.5.2Secondary end point(s)
    • Total annualized rFVIIIFc consumption per subject
    • Subjects’ individual assessments of response to treatment with rFVIIIFc for bleeding episodes, using a bleeding response scale
    • Investigators’ assessment of subjects’ response to treatment with rFVIIIFc for bleeding episodes treated in the clinic, using a bleeding response scale
    • Annualized number of spontaneous bleeding episodes (joint, soft tissue, and muscle) per subject
    • Annualized number of joint bleeding episodes (spontaneous and traumatic) per subject
    • Time from last injection of rFVIIIFc to a bleeding episode
    • Number of injections and dose per injection of rFVIIIFc required to resolve a bleeding episode (joint, soft tissue, and muscle)
    • Additional parameters for PK/pharmacodynamic (PD) assessments will include but not be limited to: AUC/dose, half-life, MRT, CL, and incremental recovery based on
    the two-stage chromogenic assay; volume of distribution (Vd), time at maximum activity (Tmax); and percent recovery for FVIII activity based on both the one-stage clotting assay and the two-stage chromogenic assay.
    For the Surgery Subgroup:
    • Investigators’/Surgeons’ assessments of subjects’ response to surgery with rFVIIIFc, using a bleeding response scale
    • Number of injections and dose per injection required to maintain hemostasis during the surgical period
    • Estimated blood loss during surgery
    • Number and type of blood component transfusions required during surgery
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through-out treatment period.
    End-points for surgery sub-group are all collected at the time of surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The Cross over element refers only to the PK subgroup, wherein PK of rFVIIIFc is compared to Advate.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Denmark
    France
    Germany
    Hong Kong
    India
    Israel
    Italy
    Japan
    New Zealand
    Poland
    Portugal
    Russian Federation
    South Africa
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    This is defined in section 7.5 of the protocol
    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 months2
    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 months6
    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.1.1.1In 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: 36
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 180
    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)
    This is described in section 7.3.3 of the protocol.
    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 Decision2011-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-06
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