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    Summary
    EudraCT Number:2014-004104-30
    Sponsor's Protocol Code Number:307-MET-9002-0009
    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 number2014-004104-30
    A.3Full title of the trial
    Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety
    A.4.1Sponsor's protocol code number307-MET-9002-0009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00174187
    A.5.4Other Identifiers
    Name:Alias protocol numberNumber:A6281016
    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 SponsorPharmacia & Upjohn S.A.
    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 supportPharmacia & Upjohn S.A
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacia & Upjohn S.A.
    B.5.2Functional name of contact pointPfizer CT.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address1, rue Antoine Lavoisier
    B.5.3.2Town/ cityGUYANCOURT
    B.5.3.3Post code78280
    B.5.3.4CountryFrance
    B.5.4Telephone number013064.34.00
    B.5.5Fax number013043.44.45
    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.3.9.2Current sponsor codeGenotropin
    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
    Juvenile idiopathic arthritis (JIA) and nephrotic syndrome (NeS)
    E.1.1.1Medical condition in easily understood language
    Inflammatory disorder of joints and kidney disorder
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 assess the effect of long-term treatment with Genotonorm on linear growth in children with short stature receiving steroid therapy
    E.2.2Secondary objectives of the trial
    To assess the effect of long term treatment with Genotonorm on bone mineralization.

    To assess the effect of long term treatment with Genotonorm on body composition.
    To assess safety (clinically and biologically eg glucose and lipid metabolism).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children with JIA or NeS,
    2. Chronological age (CA) (greater than)> 3 years old,
    3. Before or during puberty,
    4. Treated with corticoids for at least 1 year at a dose greater than equal to (>=) 0.2 mg/kg/day equivalent prednisone, IV or orally, daily or alternate day regimen, and were intending to continue corticotherapy with hGH treatment,
    5. Height less than (<) -2 standard deviation (SD) or loss of 1 SD during the 2 years preceding inclusion in the study,
    6. Bone age (BA) <13 years for females and; <14 years for males,
    7. In pubertal subjects B2 ≤breast development less than equal to (<=) B3 for females and 4 ml <= testicular volume <= 12 ml for males,
    8. Provided signed informed consent.
    E.4Principal exclusion criteria
    1. Diabetes Type 1 and 2,
    2. Endocrine disease, except well substituted hypothyroidism,
    3. Chronic renal diseases with glomerular filtration rate <50 ml/min/1.73 m2,
    4. Known or suspected allergy to the preservative m-cresol, Non compliant subjects,
    5. Subjects treated with sexual steroids (estrogens, testosterone) during the 6 months before inclusion in the study,
    6. Secondary resistance to the treatment of NeS defined by proteinuria with albuminemia <30 grams per liter (g/l) for >3 consecutive months,
    7. Malignancies,
    8. Previous human growth hormone (hGH) treatment,
    9. Inclusion in other study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    1) Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
    2) Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height
    3) Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height

    4) Puberty Stage at Final Height
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Baseline, Year 3
    2) Baseline, when final height was reached (assessed up to Year 11)
    3) Baseline, when final height was reached (assessed up to Year 11)
    4) When final height was reached (assessed up to Year 11)
    E.5.2Secondary end point(s)
    1) Bone Age
    2) Lean Body Mass
    3) Annual Percent Change in Lean Body Mass at Year 1, 2 and 3
    4) Percent Change From Baseline in Lean Body Mass at Year 3
    5) Lean Body Mass as Percentage of Total Weight
    6) Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)
    7) Fat Mass
    8) Annual Percent Change in Fat Mass at Year 1, 2 and 3
    9) Percent Change From Baseline in Fat Mass at Year 3
    10) Fat Mass as Percentage of Total Weight
    Baseline
    11) Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)
    12) Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])
    13) Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])
    14) Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])
    15) Bone Mineral Density of Total Body (BMD [TB])
    16) Bone Mineral Density of Lumbar Spine (BMD [LS])
    17) Bone Mineral Content of Total Body (BMC [TB])
    18) Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3
    19) Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3
    20) Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])
    21) Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])

    Timepoints for Secondary endpoints number 15-21 listed here:
    15) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    16) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    17) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    18) Baseline, Year 1, 2, 3
    19) Baseline, Year 3
    20) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    21) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    2) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    3) Baseline, Year 1, 2, 3
    4) Baseline, Year 3
    5) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    6) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    7) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    8) Baseline, Year 1, 2, 3
    9) Baseline, Year 3
    10)Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    11) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    12) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    13) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    14) Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
    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 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.8.3 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 years5
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days29
    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: 30
    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: 18
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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
    Prepubertal or pubertal children aged 11 to 17 years
    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 30
    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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