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    Summary
    EudraCT Number:2015-002802-34
    Sponsor's Protocol Code Number:Sandoz/OMNI/F/01/03
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-03
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-002802-34
    A.3Full title of the trial
    Multicentre study to evaluate the efficacy and safety of a liquid formulation of recombinant growth hormone, Omnitrope® 3.3mg/mL, in the treatment of pre-pubertal children of small stature suffering from somatotropin deficiency (GH) – phase IIIb
    Essai multicentrique, pour l’évaluation de l’efficacité et de la tolérance d’une hormone de croissance recombinante de formulation liquide, Omnitrop® 3,3 mg/ml, dans le traitement des enfants pré-pubères, de petite taille, présentant un déficit somatotrope (GH) – phase IIIb
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study conducted at several study sites with a human growth hormone in a liquid form and a concentration of 3.3. mg/mL that is produced by using genetic engineering techniques, to find out more about how efficacious it works and how safe its use is in pre-pubertal children of small stature who’s bodies do not produce sufficient amounts of own growth hormone.
    A.4.1Sponsor's protocol code numberSandoz/OMNI/F/01/03
    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 SponsorSandoz SAS
    B.1.3.4CountryFrance
    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 supportSandoz SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHexal AG (a Sandoz company)
    B.5.2Functional name of contact pointHead Strategic Planning, BCD
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestraße 25
    B.5.3.2Town/ cityHolzkirchen
    B.5.3.4CountryGermany
    B.5.4Telephone number004980244760
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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) 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
    Small stature secondary to growth hormone insufficiency deficiency
    E.1.1.1Medical condition in easily understood language
    Small stature due to insufficient production of growth hormone in the body
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy and tolerance of Omnitrope® 3,3 mg/ml solution fo injection, administered at a dose of 0,23 mg/kg/s on a clinical, biological and immunological level
    E.2.2Secondary objectives of the trial
    Tolerance and acceptability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Small stature due to growth hormone deficiency
    • Age: girls of under 10 years of age and boys of under 12
    • Height ≤ -2 SD or < -1.5 SD with slow Growth Rate (GR < -1 SD or < 4 cm/year)
    • Weight in line with statural age ± 2SD
    E.4Principal exclusion criteria
    • Prior or current treatment with GH
    • Presence of an active tumour; a lapse of at least 12 months will be required since tumour treatment
    • Current corticosteroid treatment other than substitution treatment or use of an inhaled corticosteroid
    • Insulin-dependent diabetes (according to the WHO definition), or other chronic, severe disease
    • Small stature for other reasons than growth hormone deficiency
    • Peutz-Jeghers syndrome or a family history of colon cancer
    E.5 End points
    E.5.1Primary end point(s)
    1. Increase in growth rate over 12 month
    2. Increase in levels of IGF-1 levels and growth hormone dependent markers (Acid-Labile Subunit (ALS), IGFBP-3)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Over 12 months
    2. Every 6 months
    E.5.2Secondary end point(s)
    1. Local tolerance at injection site and in general
    2. Acceptability of injection pen and tolerance of injections
    3. Systemic tolerance by laboratory test results and adverse events
    4. Immunologic tolerance by assessing the formation of anti-growth-hormone antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At each visit
    2. After 12 months
    3. Every 6 months
    4. At inclusion and after 6 and 12 months
    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 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 No
    E.8.1.1Randomised No
    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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    France
    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
    Clinical trial phase: 12 months
    Follow-up period: up until licensing of the product
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    After one year of treatment in the clinical trial phase, patients will enter the follow-up period and continue their treatment at the same dose until the product becomes commercially available in the country (France).
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: France
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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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