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    Summary
    EudraCT Number:2010-020742-10
    Sponsor's Protocol Code Number:8-79-52800-011
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-020742-10
    A.3Full title of the trial
    Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGH
    Dose Therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].
    A.4.1Sponsor's protocol code number8-79-52800-011
    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 SponsorIpsen Pharma
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma
    B.5.2Functional name of contact pointGlobal Medical Affairs
    B.5.3 Address:
    B.5.3.1Street Address65 quai Georges Gorse
    B.5.3.2Town/ cityBoulogne Billancourt Cedex
    B.5.3.3Post code92650
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 58 33 51 81
    B.5.5Fax number+33 1 58 33 50 65
    B.5.6E-mailhugues.berard@ipsen.com
    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 NutropinAq 10 mg/2 ml
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 12629-01-5
    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) 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.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 INCRELEX 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNMecasermin
    D.3.9.1CAS number 67763-96-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 NutropinAq 10 mg/2 ml
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 12629-01-5
    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) 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
    Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
    E.1.1.1Medical condition in easily understood language
    Young children with lack of Growth hormone and not responding well to Growth hormone treatment.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a superior efficacy on height velocity (HV) of treatment with a combination of flexible rhIGF-1 dose and 0.035 mg/kg/day of rhGH, as compared to treatment with 0.035 mg/kg/day of rhGH only, after one year of treatment in pre-pubertal children with IGHD, showing a poor response to rhGH treatment during the first treatment year.
    E.2.2Secondary objectives of the trial
    • To assess:
    - effect on HV, delta height SDS, HV SDS of flexible rhIGF-1 dose and fixed rhGH dose combination therapy vs. fixed rhGH dose therapy
    - safety of flexible rhIGF-1 dose and fixed rhGH dose combination vs. fixed rhGH dose therapy
    - effect on serum concentrations of GH and IGF-1 and their binding proteins during flexible rhIGF-1 dose and fixed rhGH dose combination therapy vs. fixed rhGH dose therapy
    - effect on serum concentrations of IGF-1 and GH, IGF-1 SDS before and 2 to 6 hours after IMP injection(s)
    - effect on change of IGF-1 SDS
    - effect on pubertal status
    - change in bone age
    • To identify prognostic factors of therapeutic response to flexible rhIGF-1 dose and fixed rhGH combination therapy, based on historical data (pre rhGH treatment and at study start), on GH stimulation tests, IGF-1, auxology and diagnosis
    • To assess changes in fasting metabolic parameters
    • To assess changes in anti-GH and anti-IGF-1 antibodies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Treatment with rhGH at a minimum starting dose of 0.025 mg/kg/day (without dose reduction) to a maximum dose of 0.035 mg/kg/day for at least 12 months and a maximum of 18 months based on the diagnosis of IGHD with a pre-treatment GH stimulation test/spontaneous maximum of GH < 10µg/L
    • First year of rhGH treatment resulting in height gain < 0.5 SDS
    • Chronological age from 3 to 9 years inclusive for girls, from 3 to 10 years inclusive for boys
    • Pre-pubertal: Tanner stage 1 (Girls: Tanner B1, Boys: Testis ≤ 3ml)
    • Parent(s)/guardian(s) have provided written informed consent
    E.4Principal exclusion criteria
    • Evidence (more than 20% rhGH injections missed) or suspicion of poor compliance during the first year of rhGH treatment
    • Hypothalamic-pituitary tumours or malformations diagnosed or treated prior to screening
    • Any history of cancer and/or evidence of any active malignancy or intracranial tumours
    • Co-morbidity known to affect linear growth including, but not limited to, skeletal dysplasia
    • Chronic illness including but not limited to diabetes, inborn errors of metabolism, osteochondrodystrophy, disorders of genitourinary, cardiopulmonary, gastrointestinal, or central nervous system
    • Any named syndrome known to be associated with short stature but not limited to Prader-Willi syndrome, Russel Silver syndrome, etc.
    • Neurological disease and mental disabilities that may interfere with compliance [Attention Deficit Hyperactivity Disorders (ADHD), autism, Asperger]
    • Ongoing drug treatment known to alter growth, including but not limited to high dose glucocorticoids
    • Multiple hormonal deficiencies except hypothyroidism if corrected and well controlled
    • Clinically significant abnormal findings at previous fundoscopy or echocardiogram, that could be worsened by rhGH and/or rhIGF-1 administration
    • Significant abnormality in clinical screening laboratories, as determined by the Investigator
    • Syndromes that predispose the subject to cancer (e.g. Fanconi syndrome, Bloom syndrome, ataxia telangectasia)
    • Active seizure disorders, defined as one or more seizures per month irrespective of anticonvulsant therapy
    • Known allergy or hypersensitivity to any components of NutropinAq® (somatropin) or Increlex® (mecasermin)
    • Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental traumas or acute respiratory failure
    • Any current or previous exposure to therapeutic spinal irradiation
    • Prior bone marrow transplantation
    • Evidence of clinical malnutrition or growth deficit attributable to emotional deprivation
    • Participation in a clinical trial within the last 12 weeks
    • Any social or medical condition that, in the opinion of the Investigator, would be detrimental to either the subject or the study
    E.5 End points
    E.5.1Primary end point(s)
    Difference in mean HV between the two treatment groups after 1 year of treatment. A difference of ≥ 1.5 cm/year is considered to be clinically relevant.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (Visit 2) to week 52 (Visit 8).
    E.5.2Secondary end point(s)
    1) Difference in mean HV
    2) Difference in delta height SDS
    3) Difference in mean HV SDS
    4) Change in serum concentration of GH, IGF-1 and IGFBP-3
    5) Change in:
    - serum concentration of IGF-1 and GH
    - IGF-1 SDS
    before and 2 to 6 hours after IMP injection(s).
    6) Change in IGF-1 SDS
    7) Change in serum concentration of Growth Hormone Binding Protein (GHBP) and ALS
    8) Change in pubertal status
    9) Change in bone age
    10) Identification of prognostic factors of therapeutic response, based on historical data (pre rhGH treatment and at study start), on GH stimulation tests, IGF-1, auxology and diagnosis
    11) Change in fasting metabolic parameters: Insulin, IGFBP-1, glycosylated haemoglobin and lipid profile over the course of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) from baseline to 26 and 39 weeks
    2) after 13, 26, 39, and 52 weeks
    3) from baseline to 26, 39, and 52 weeks
    4) from baseline to 2, 4, 13, 26, 39, and 52 weeks
    5) before and 2 to 6 hours after first dose administered at Day 1 (baseline visit), 2 weeks and 52 weeks.
    6) from Day 1 (baseline visit) to 2, 4, 13, 26, 39, and 52 weeks (based on the 2 to 6 hours sampling result)
    7) from Day 1 (baseline visit) to 52 weeks
    8) from screening to Day 1 (baseline visit), 4, 13, 26, 39, and 52 weeks
    9) from screening to 52 weeks
    10) historical data
    11) from baseline to 2 and 52 weeks
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective and multi-centre
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 63
    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: 63
    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 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
    Young children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 63
    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)
    A follow-up study is planned.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation To be completed locally (if applicable)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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