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    Summary
    EudraCT Number:2007-003586-41
    Sponsor's Protocol Code Number:A6281289
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-11-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-003586-41
    A.3Full title of the trial
    Placebo-controlled trial on the efficacy of growth hormone replacement therapy in
    patients with growth hormone deficiency after traumatic brain injury
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA6281289
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Ltd. 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Genotropin/GENOTONORM®
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER Holding France
    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 nameGenotropin/GENOTONORM®
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeGenotropin/GENOTONORM®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.3
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder 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
    Growth hormone deficiency after traumatic brain injury
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to establish the effects of Growth Hormone (GH) replacement in patients with severe GH deficiency after Traumatic Brain Injury (TBI) on cognitive function.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to establish the effect of GH replacement in subjects with severe GH deficiency after TBI on lean body mass and fat mass; Extended Glasgow-Outcome-Scale (GOS-E); SF-36 Health Survey; Assessment of Growth Hormone Deficiency in Adults (AGHDA) questionnaires and cardiovascular risk profile, as well as to demonstrate the safety of growth hormone treatment in this patient population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Have 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. Be at least 18 years of age and at the age of legal consent, and no older than 55 years of age.
    3. If female, be not of child-bearing potential (i.e. surgically sterile or postmenopausal for at least one year), or be non-pregnant and using an acceptable method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) for at least one month prior to the screening visit if necessary, and for the duration of the study period.
    4. Have had a previous Traumatic Brain Injury (TBI) (more than 1 year and less than 10 years) prior to the screening visit.
    5. Have an Extended Glasgow Outcome Scale (GOS-E) ≥ 5.
    6. Have proven severe GH deficiency as diagnosed by dynamic testing within the last 6 months. Subjects who have had dynamic testing within a year of their brain trauma will require repeat testing prior to entrance into the study. The preference is for either using the insulin tolerance test (ITT) with a cut-off of 3 µg/l, provided that there are no contraindications, the GHRH-Arginine test with appropriate cut-off values for severe GH deficiency according to BMI, or the Glucagon test with a cut-off of 3 µg/l.
    7. Have: A proven isolated GH deficiency without other pituitary hormone insufficiencies.
    8. Be on stable concomitant medications for 1 month prior to entry.
    9. Be likely to comply with the protocol, scheduled visits, laboratory tests and medication regimen.
    10. Be fluent in the language of the investigator and study staff and who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Has any current malignancy except:
    a. Those >5 years ago without recurrence.
    b. Excised basal cell carcinoma or squamous cell cancer.
    2. History of cranial irradiation.
    3. Growth hormone replacement therapy in the last 12 months.
    4. History of hypothalamic / pituitary disease which was diagnosed prior to TBI.
    5. History of dementia unrelated to TBI.
    6. History of benign intracranial hypertension.
    7. Have a significant medical condition (e.g. renal, hepatic, respiratory, cardiovascular, hematologic, immunologic, papilloedema), which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations.
    8. Diabetes mellitus requiring treatment by oral hypoglycemic agents or insulin.
    9. Other severe, acute or chronic medical or psychiatric conditions or laboratory
    abnormality that may increase the risk associated with study participation 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.
    10. Cognitive or neuromuscular impairment too severe to allow assessment with the
    CogState™ battery.
    11. Have a positive result on a urine pregnancy test at screening, or the intention to become pregnant or breastfeed during the course of the trial. Because the effects of growth hormone replacement on the fetus and developing infant are not known, subjects who are pregnant or breast-feeding will be excluded from the study.
    12. Have been judged by the investigator to be medically non-compliant in the management of their treatment.
    13. Have taken another investigational drug within 30 days prior to baseline.
    14. Have a known or suspected drug or alcohol abuse/dependence (excluding nicotine and caffeine).
    15. Known hypersensitivity to the active substance or to any of the excipients.
    16. Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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 EEA22
    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 Information not present in EudraCT
    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
    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 months3
    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 months3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-12-22
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