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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

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    Summary
    EudraCT Number:2006-002506-58
    Sponsor's Protocol Code Number:EP00-401
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-002506-58
    A.3Full title of the trial
    Long-term phase IV multicentre study on the safety and efficacy of Omnitrope® (rhGH) in short children born Small for Gestational Age (SGA)
    A.4.1Sponsor's protocol code numberEP00-401
    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 SponsorSandoz GmbH
    B.1.3.4CountryAustria
    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 Omnitrope®
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOmnitrope
    D.3.4Pharmaceutical form Powder and solvent 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.3.11 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 Yes
    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 Yes
    D.2.1.1.1Trade name Omnitrope®
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOmnitrope
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNSOMATROPIN
    D.3.9.1CAS number 12629015
    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) 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 Yes
    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
    Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018747
    E.1.2Term Growth hormone
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluation of the long-term effect of growth hormone treatment on the development of diabetes during the treatment period in short children born SGA
    E.2.2Secondary objectives of the trial
    • report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies during treatment
    • evaluation of the efficacy (with respect to changes in height parameters) of Omnitrope® treatment in short children born SGA
    • evaluation of IGF-I and IGFBP-3 levels during treatment
    • evaluation of incidence and severity of adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pre-pubertal (Tanner stage I) children born SGA
    • Boys: equal or above 4 years of age (bilateral testicular volume < 4 ml)
    • Girls: equal or above 4 years of age (bilateral Tanner breast stage I)
    2. Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS < -1) for chronological age and sex according to country specific references, If country specific references are not available, pre-defined published references will be used
    3. Birth weight and/or length below -2 SD for gestational age (according to country specific references). For the evaluation of gestational age, the date of the last menstrual period or ultrasonographic data obtained during the pregnancy should be used. If country specific references are not available, pre-defined published references will be used
    4. Height records at least of the last 6 months must be available
    5. Calculated height velocity SDS < 0 during the last year according to Prader 1989
    6. Written informed consent of patient (for children who can read or understand) and parent or legal guardian
    E.4Principal exclusion criteria
    1. Onset of puberty
    2. Closed epiphyses
    3. Diabetes mellitus type I or type II
    4. Fasting blood glucose equal or above 100 mg/dl (5.6 mmol/l) measured in venous blood sample
    5. Abnormal findings in OGTT defined by equal or above 140 mg/dl (7.8 mmol/l) after 120 minutes
    6. Known IGF-I level above +2SD for sex and age
    7.
    8. Acute critical illness e.g. suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure.
    9. Known to be hepatitis B or hepatitis C positive or HIV-positive, known to have advanced diseases such as AIDS or tuberculosis
    10. Any other disease, genetic disorder or malformation or treatment known to be associated with growth retardation, e.g. Turner or Noonan syndrome, Laron syndrome, Russell-Silver syndrome, Prader-Willi syndrome, skeletal dysplasias, chronic renal failure, cystic fibrosis, heart and liver diseases, malabsorption (coeliac disease), malnutrition, patients receiving radiation therapy of head or spinal cord
    11. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
    12. Known or suspected hypersensitivity to rhGH or any of the excipients (e.g. benzyl alcohol)
    13. Previous treatment with any hGH preparation
    14. Oral, inhalative or parenteral treatment with glucosteroids, except for physiological replacement, or hypothyroidism which has been left untreated, or was inadequately treated, or treated for less than 3 months
    15. Treatment with LHRH / gonadotropin releasing hormone (GnRH) analoga (e.g. triptorelin)
    16. Treatment with antidiabetic medication (e.g. metformin, insulin)
    17. Drug abuse, substance abuse, or alcohol abuse
    18. Known to be immunocompromised
    19. Intake of growth promoting medication, e.g. anabolic steroids
    20. Use of other investigational drugs within 30 days of enrolment
    21. Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints:
    - Carbohydrate metabolism:
    Fasting plasma glucose and insulin levels will be measured at baseline, at 6 and 12 months, then annually during Omnitrope® treatment, and at the end of treatment.
    Glycosylated haemoglobin (HbA1C) will be measured at baseline, at 6 and 12 months and then annually during Omnitrope® treatment, and at the end of treatment.
    An oral glucose tolerance test (OGTT) will be performed at baseline, at 6 and 12 months and then annually during Omnitrope® treatment, and at the end of treatment.
    - Immunogenicity
    Anti-rhGH antibodies and E. coli host cell peptide (HCP) antibodies will be measured at baseline, at 3, 6, 9, 12, 18 and 24 months, then annually during Omnitrope® treatment, and at the end of treatment.
    - Safety lab / urine analysis
    Hematology, blood chemistry and urine analysis will be measured at baseline, at 6 and 12 months, then annually during Omnitrope® treatment, and at the end of treatment.
    - (Serious) Adverse events:
    Adverse events will be collected throughout the study.
    - Vital signs / weight:
    Vital signs (blood pressure, pulse) as well as weight and pubertal status will be examined at each visit. BMI will be calculated at each visit.

    Efficacy endpoints:
    - Auxological:
    Height, height SDS, height velocity and height velocity SDS will be monitored at baseline, at every 3 months during Omnitrope® treatment and at the end of treatment.
    - Pharmacodynamic:
    IGF-I and IGFBP-3 serum levels will be assessed at baseline, at 3, 6, 9 and 12 months, then bi-annually during Omnitrope® treatment, and at the end of treatment.
    - Bone age:
    Bone age readings will be performed at baseline if historical (screening) X-ray dates older than six months, at the end of each treatment year and at the end of treatment.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 years15
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years15
    E.8.9.2In all countries concerned by the trial months0
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated until final height has been reached. In a follow-up study (protocol EP00-402), patients will be followed for another 10 years for long-term safety following Omnitrope® treatment.
    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 Decision2008-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-25
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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