Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-000830-37
    Sponsor's Protocol Code Number:CP-4-005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-09
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2013-000830-37
    A.3Full title of the trial
    A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency
    A.4.1Sponsor's protocol code numberCP-4-005
    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 SponsorOPKO Biologics Ltd.
    B.1.3.4CountryIsrael
    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 supportOPKO Biologics Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationinVentiv Health Clinical UK Ltd.
    B.5.2Functional name of contact pointRegulatory Operations
    B.5.3 Address:
    B.5.3.1Street AddressThames House, 17-19 Marlow Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 7AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628408408
    B.5.5Fax number+441628408401
    B.5.6E-mailregopseurope@inventivhealth.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 numberEMA/OD/133/12
    D.3 Description of the IMP
    D.3.1Product namen/a
    D.3.2Product code MOD-4023
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNna
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codeMOD-4023
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN GROWTH HORMONE
    D.3.9.4EV Substance CodeSUB20678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 numberEMA/OD/133/12
    D.3 Description of the IMP
    D.3.1Product namen/a
    D.3.2Product code MOD-4023
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNna
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codeMOD-4023
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN GROWTH HORMONE
    D.3.9.4EV Substance CodeSUB20678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 numberEMA/OD/133/12
    D.3 Description of the IMP
    D.3.1Product namen/a
    D.3.2Product code MOD-4023
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNna
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codeMOD-4023
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN GROWTH HORMONE
    D.3.9.4EV Substance CodeSUB20678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 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
    Adult or childhood onset growth hormone deficiency (GHD)
    E.1.1.1Medical condition in easily understood language
    Adult or childhood onset growth hormone deficiency (GHD)
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.2System Organ Class 10014698 - Endocrine 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 demonstrate a clinical superiority of MOD-4023 over placebo in terms of decrease in Fat Mass (FM) in adult subjects with GHD
    E.2.2Secondary objectives of the trial
    •To determine the efficacy of MOD-4023 over placebo in other body composition variables (such as lean body mass and waist-to-hip ratio)
    •To evaluate the safety and tolerability of MOD-4023 over placebo in adult subjects with GHD
    •To determine the IGF-I and IGFBP-3 serum levels
    •To monitor long-term safety and efficacy of MOD-4023 in adult subjects with GHD who completed Treatment Periods I and II of this study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women between the age of 23 to 70 years old at screening, inclusive
    2. GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007). The following cutoff values for the diagnosis of GHD will be used
    • Insulin tolerance test or glucagon test, the validated cutoff for GHD in adults is a peak GH response ≤ 3 µg/L
    • Growth-hormone-releasing hormone (GHRH) + arginine: for those with a body mass index:
    - BMI <25 kg/m2, a peak GH ≤11 µg/L;
    - BMI 25–30 kg/m2 (included), a peak GH≤8 µg/L;
    - BMI >30 kg/m2, a peak GH≤4 µg/L.
    3. Subjects using hormonal replacement therapy(s) for deficiencies of other hypothalamo-pituitary axes must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening:
    • Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is acceptable.
    • Peripheral thyroid hormones (FT4) within the normal range of the central or local lab.
    • Adrenal insufficiency – documented adrenal status (subjects that are sufficient with documented test in last 6 months or insufficient and on stable replacement).
    4. Subjects with Diabetes Insipidus should be on stable treatment for at least 6 months
    5. No rhGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational rhGH or GH secretagogue product.
    6. The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements.
    7. For patients treated for Cushing's, at least two years elapsed since pituitary surgery and in biochemical remission without current medical therapy for the condition, documented within 6 months of study entry
    8. Body Mass Index (BMI, kg/m2) of 23.0 to 35.0 kg/m2, both inclusive
    9. Confirmed to be negative for anti r-hGH antibodies at the time of screening.
    10. Women of childbearing potential and fertile men must agree to use appropriate contraceptive methods during the study until one month after the last study visit. For the purposes of this protocol, a history of tubal ligation, bilateral oophorectomy or hysterectomy, or post-menopausal women constitutes non-fertility. Fertile men must agree to use a barrier contraceptive (condom). Vasectomy older than 6 months is also acceptable.
    11. Women of childbearing potential must have a negative serum pregnancy test at inclusion.
    12. Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months.
    13. Subject had a DXA screening and the results are interpretable according to the study plan.
    14. Willing and able to provide written informed consent prior to performing any study procedures.

    Inclusion into Treatment Period III (LT-OLE):
    1. Completion of Treatment Periods I and II of study CP-4-005
    2. Signing consent form for Treatment Period III
    3. Investigator's approval of the patient anticipated compliance and
    safety
    4. Agreement to comply with use of contraception in women of child
    bearing potential and fertile men.
    E.4Principal exclusion criteria
    1. Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
    2. Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
    3. Suspected or diagnosed ongoing cancer or history of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
    4. Signs of intracranial hypertension at screening
    5. Heart insufficiency, NYHA class > 2 (Appendix C)
    6. History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteria, including ongoing administration of anti-diabetic medications/agents. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
    7. Impaired liver function defined as:
    a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal (ULN) at Screening visit in a patient without prior history of elevated LFTs 5(non-alcoholic fatty liver disease is not excluded, but requires etiological clarification prior to eligibility confirmation)
    OR
    b. Total bilirubin greater than 2 times the ULN at Screening
    8. Subjects with severe renal failure at the Screening visit (defined by GFR < 30 mL/min using MDRD Study Equation)
    9. History of Acromegaly
    10. For patients treated for Cushing's, biochemical, documented evidence of possible recurrence within 2 months of study entry according to 2008 Endocrine Society Guideline
    11. Active Carpal tunnel syndrome suspected on a recent history (last 6 months) or ongoing symptoms such as: Numbness, or tingling in hand and/or finger, pain in the arm, palm or forearm, both occurring also at night and with intensive use of the hand; trouble gripping objects and weakness in the thumb.
    12. Systemic corticosteroids other than in replacement doses within the 3 months before study entry (temporary adjustment of glucocorticoids, as appropriate, is acceptable)
    13. Anabolic therapy or supplements (subject to Medical Monitor's decision) other than gonadal steroid replacement therapy within 2 months before study entry
    14. History of non-compliance with medications, un-cooperativeness or drug abuse
    15. Subjects who, based on the investigator’s judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include cardiovascular, peripheral vascular, pulmonary, hepatic, renal, or neurological disease, as determined by medical history, physical examination, laboratory tests or ECG.
    16. Subjects who participated in any study and had administration of an investigational medicinal product (IMP) within the last 2 months. Subjects with previous participation in investigational studies must have recovered from all adverse effects.
    17. Subjects who participated within the last 12 months in any clinical trial involving the use of medicinal products (investigational or approved) that impact insulin levels, or that included specific dietary or physical activity requirements are excluded
    18. History of positive serology to HBC, HBV and HIV (patients that have been previously vaccinated and therefore have positive serology are not excluded)
    19. Subjects with genetic causes of familial lipodystrophy.
    20. Subjects who are confined to an institution by official directives or
    court order.

    Specific Exclusion for Treatment Period III (LT-OLE)
    1. Unresolved drug related SAE from previous treatment periods
    2. Clinical or imaging evidence of pituitary tumor growth
    3. Diagnosis of ongoing cancer
    4. Duration longer than 3 months since the last dose in Treatment Period
    II of study CP-4-005, except if the cause for delay is due to study
    logistics (i.e.: extended approval timelines or lack of clinical supplies)
    5. Uncontrolled diabetes mellitus (HbA1C ≥ 8.5%)
    6. Subjects who, based on the investigator's judgment, have a clinically
    significant or unstable medical or surgical condition that may preclude
    safe and complete study participation. Conditions may include
    cardiovascular, peripheral vascular, pulmonary, hepatic, renal, or
    neurological disease, as determined by physical examination, laboratory
    tests or ECG.
    7. Detectable neutralizing antibodies to MOD-4023
    8. Participation in another clinical trial (drug administration), other than
    CP-4-005, in the past 90 days.

    E.5 End points
    E.5.1Primary end point(s)
    Change in trunk fat mass (FM), expressed in kilograms measured with DXA, from baseline to 26 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 26
    E.5.2Secondary end point(s)
    Changes in body composition:
    •Change in total FM, expressed in kilograms, measured with DXA, from baseline to 26 and 52 weeks
    •Change in lean body mass, expressed in kilograms measured with DXA, from baseline to 26 and 52 weeks
    •Change in trunk FM, expressed in kilograms measured with DXA, from baseline to 52 weeks
    •Change in trunk FM, expressed as % change from baseline, measured with DXA, from baseline to 26 and 52 weeks
    Change in Biochemical markers:
    •Change of IGF-I and IGF-I SDS levels across study visits
    •Change of IGFBP-3 levels across study visits
    •Proportion of subjects achieving normalization of IGF-1 levels during and at the end of each treatment period (week 26, week 52 and end-of study).

    Additional Measurements:
    •Change in QoL from baseline across study visits
    •Change in Waist-to-hip ratio from baseline across study visits
    •Change in bone density from baseline on a yearly basis during Treatment Period III
    •Change in fat and lean body mass from baseline on a yearly basis during Treatment Period III
    •Change in lipid profile: fasting HDL cholesterol, LDL cholesterol, triglycerides, Lp(a) from baseline on a six-monthly basis.

    Safety and Tolerability
    •AEs and local tolerability (injection site reaction)
    •Parameters of glucose metabolism:
    -Fasting insulin level
    -Fasting glucose levels
    -HbA1c levels
    •Immunogenicity
    -Anti MOD-4023 Neutralizing Antibody occurrence
    •IGF-I levels
    •MOD-4023 levels
    •Status of other hormonal axes
    -Thyroid hormones (Free T4, T3 and TSH)
    -Morning cortisol levels
    -Prolactin levels (screening, 6 months, 12 months)
    •Other safety laboratory parameters, including serum chemistry profile, liver enzymes, hematology and urinalysis
    •Vital signs including body mass index (BMI)
    •ECG (screening, 6 months, 12 months and yearly thereafter)
    •Fundoscopy for the occurrence of increased intracranial pressure (if PI feels it is required).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes in body composition from baseline to 26 and 52 weeks

    Change in Biochemical markers across the visits
    Additional Measurements

    Safety and Tolerability
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Armenia
    Australia
    Austria
    France
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Taiwan
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 170
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 20
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 190
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-20
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA