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    Summary
    EudraCT Number:2014-004160-38
    Sponsor's Protocol Code Number:93-8122-001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-01
    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 number2014-004160-38
    A.3Full title of the trial
    A 2 Year Multicenter Study of Genotropin Treatment of Short Prepubertal Children with Intra-Uterine Growth Retardation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
    A.4.1Sponsor's protocol code number93-8122-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01073605
    A.5.4Other Identifiers
    Name:AliasNumber:A6281186
    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 SponsorKABI PHARMACIA S.A.
    B.1.3.4CountrySweden
    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 supportKABI PHARMACIA S.A.
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKABI PHARMACIA (FRANCE)
    B.5.2Functional name of contact pointDoctor Fabienne LANDIER
    B.5.3 Address:
    B.5.3.1Street Address1, rue Antoine Lavoisier
    B.5.3.2Town/ cityST QUENTIN-YVELINES CEDEX
    B.5.3.3Post code78051
    B.5.3.4CountryFrance
    B.5.4Telephone number33130-64-34-00
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGenotropin
    D.3.4Pharmaceutical form Powder and solution for 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 INNSomatropin
    D.3.9.3Other descriptive nameSOMATROPIN
    D.3.9.4EV Substance CodeSUB10584MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5.3 to 12
    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
    Growth Disorders, Intrauterine Growth Retardation
    E.1.1.1Medical condition in easily understood language
    Growth Disorders, Intrauterine Growth Retardation
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    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
    To evaluate the effect of continuous and intermittent administration of Genotonorm 16 international unit (IU) on stature in prepubertal short children with intra-uterine growth retardation (IUGR) as measured by height velocity (centimetre [cm]/year) at 24 months.
    E.2.2Secondary objectives of the trial
    Evaluation of the effect of 3 treatment regimens on height at 3 years (using height standard deviation score [SDS]). Evaluate the safety of 3 treatment regimens as measured by clinical and laboratory parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Chronological age (CA) between 3 and 10 years for girls.
    2. Chronological age between 3 and 12 years for boys.
    3. Height for CA below - 2 standard deviation (SD).
    4. Height velocity for chronological age below 0 SD based on 9 to 15 months observation period before inclusion.
    5. Birth weight known.
    6. Birth length for gestational age below - 2 SD.
    7. Gestational age known.
    8. Prepubertal stage (Boys): Testosterone less than or equal to (<=) 0.30 nanogram per milliliter (ng/mL), Testis volume <=2 mL; Prepubertal stage (Girls): Pelvis echography : no sign of puberty, Uterus length =<30 millimeter (mm), Breast development <B2 (Tanner Scale).
    9. Bone age done within 3 months prior to study entry.
    10. A provocation test giving a growth hormone (GH) level >=10 ng/mL.
    11. Known parental height.
    12. Signed written informed consent obtained from the patient's parent/guardian.
    E.4Principal exclusion criteria
    1. Endocrine disease except well-substituted hypothyroidism.
    2. Sever chronic disease(example [e.g.] diabetes mellitus, renal or liver disease).
    3. Skeletal dysplasia.
    4. Known chromosomal aberration.
    5. Previous irradiation therapy
    6. Ongoing pharmacological treatment with steroids.
    7. Known intrauterine infection.
    8. Microcephaly, defined as head circumference below -2 SD.
    9. Previous treatment with GH or GH-releasing hormone [RH]
    10. Subjects who have known or suspected allergy to the preservative m-cresol.
    E.5 End points
    E.5.1Primary end point(s)
    Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 2 years
    E.5.2Secondary end point(s)
    1) Annual Growth Rate Standard Deviation Score (SDS)
    2) Change From Baseline in Annual Growth Rate SDS
    3) Height (cm)
    4) Change From Baseline in Height (cm)
    5) Height (SDS)
    6) Change From Baseline in Height (SDS)
    7) Body Mass Index (BMI)
    8) Weight
    9) Change From Baseline in Bone Age
    10) Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio
    11) Chronological Age at Onset of Puberty
    12) Number of Subjects Reaching Puberty
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline, 1 to 6 years
    2) Baseline, 1 to 3 years
    3) Baseline, 1 to 6 years, final height
    4) Baseline, 1 to 6 years, final height
    5) Baseline, 1 to 6 years, final height
    6) Baseline, 1 to 6 years, final height
    7) Baseline, 1 to 6 years
    8) Baseline, 1 to 6 years
    9) Baseline, 1 to 3 years
    10) 1 to 3 years
    11) Onset of puberty
    12) Baseline, 1 to 6 years
    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 No
    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 Information not present in EudraCT
    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 trial3
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years15
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days7
    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: 206
    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: 206
    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 No
    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
    Subjects less than 18 years of age
    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 206
    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)
    None
    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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