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    Summary
    EudraCT Number:2015-001939-21
    Sponsor's Protocol Code Number:GX-H9-003
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-22
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-001939-21
    A.3Full title of the trial
    A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency
    A hosszú hatású hibrid Fc-fúziós rekombináns humán növekedési hormon (GXH9) fázis II randomizált, nyílt elrendezésű, aktív kontrollos dóziskereső vizsgálata növekedési hormon hiányban szenvedő gyermekeknél.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9
    A.4.1Sponsor's protocol code numberGX-H9-003
    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 SponsorGenexine, Inc.
    B.1.3.4CountryKorea, Republic of
    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 supportGenexine, Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd.
    B.5.2Functional name of contact pointClinical Trials Info
    B.5.3 Address:
    B.5.3.1Street Address50 Miskolci Str.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1147
    B.5.3.4CountryHungary
    B.5.4Telephone number+36 1299 00 91
    B.5.5Fax number+361299 00 96
    B.5.6E-mailclinicaltrials@accelsiors.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 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 nameGX-H9
    D.3.4Pharmaceutical form 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 INNnone
    D.3.9.2Current sponsor codeGX-H9
    D.3.9.3Other descriptive namehGH-hyFc, recombinant human growth hormone
    D.3.9.4EV Substance CodeSUB129967
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 No
    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 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 Genotropin®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 solvent 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.3.9.1CAS number 12629-01-5
    D.3.9.3Other descriptive namerecombinant DNA-derived human growth hormone
    D.3.9.4EV Substance CodeSUB10584MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 No
    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 Hormone Deficiency (GHD) in pre-pubertal children
    E.1.1.1Medical condition in easily understood language
    Lack of growth hormone in the body
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the safety, efficacy and tolerability of two weekly and one every other week (EOW) GX-H9 treatments to that of a commercially available standard daily recombinant human growth hormone (rhGH) formulation in pre-pubertal children with growth failure due to insufficient secretion of endogenous growth hormone.
    To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of 3
    different doses of GX-H9 in pre-pubertal growth hormone deficient (GHD) children.
    To select the optimal dose(s) of GX-H9 for the subsequent Phase 3 study on the basis of safety and efficacy.
    To evaluate immunogenicity of GX-H9.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Pre-pubertal children with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone insufficiency, idiopathic or organic GH insufficiency (e.g., due to pituitary tumor, pituitary or brain surgery):
    •Boys: 3 years ≤ boy’s age ≤ 11 years
    •Girls: 3 years ≤ girl’s age ≤ 10 years
    2.GHD confirmed by 2 different GH provocation tests with peak GH concentration below 10 ng/mL as described in consensus guidelines. Well documented historical GH provocation tests can be used for study eligibility providing that the tests are performed as defined in Appendix 2 (e.g. the same sampling time points). Data of each historical GH stimulation test will be reviewed by Medical Monitor and Sponsor in order to assess acceptance for the study;
    3.Without prior exposure to any rhGH therapy;
    4.Bone age (BA) is not older than chronological age and should not be greater than 9 years for girls and 10 years for boys;
    5.Impaired height and height velocity defined as:
    •Height (HT) of at least 2.0 standard deviations (SD) below the mean height for chronological age (CA) and gender according to the standards from Prader et. al 1989, (HT SDS ≤ -2.0)
    •Annualized height velocity (HV) of at least 1 SD below the mean HV for chronological age and gender according to the standards of Prader et al (1989). The interval between two height measurements should be at least 6 months (but not longer than 18 months) before inclusion.
    6.All subjects must have at least one cranial imaging study [magnetic resonance imaging (MRI) or computed tomography (CT)] prior to randomization:
    •To exclude intracranial causes of GHD in subjects without history of pituitary tumor [obtained within 6 months prior to informed consent signing, or
    •Subjects with a previously treated pituitary tumor must have no tumor progression for at least the past year [obtained within 3 months prior to informed consent signing, compared with a previous MRI or CT performed at least 12 months earlier].
    •If not performed within these specified time frames prior to informed consent signing, may be performed as a part of the screening procedures.
    7.Body mass Index (BMI) must be within ±2 SD of mean BMI for the chronological age and sex according to the 2000 CDC standards;
    8.Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS≤ -1.0) according to the central laboratory reference values. One IGF-1 retest is allowed during the Screening period if first results were not higher than -0.85 SDS and if GH stimulation tests results and auxology parameters met eligibility criteria;
    9.Children with normal fundoscopy (ophthalmoscopy) at screening
    (without signs/symptoms of intracranial hypertension as assessed by fundoscopy) – it is highly recommended to take a photograph (if equipment is available at the study center);
    10.Children with multiple hormonal deficiencies must be on stable replacement therapies for other hypothalamo-pituitary-organ axes for at least 3 months and 6 months for thyroid replacement therapy prior to Screening. Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is acceptable;
    11.Normal 46 XX karyotype for girls;
    12.Written informed consent of the parent or legal guardian of the subject and assent of the subject (if the subject can read);
    13.Parent or legal guardian who is capable and willing to administer the study drug.
    E.4Principal exclusion criteria
    1.History of radiation therapy or chemotherapy;
    2.Malnourished children defined as:
    •Serum albumin below the lower limit of normal (LLN) according to the reference ranges of central laboratory; and
    •Serum iron below the lower limit of normal (LLN) according to the reference ranges of central laboratory; and
    •BMI<-2 SD for age and sex;
    3.Children with psychosocial dwarfism;
    4.Children born small for gestational age (SGA-birth weight and/or birth length < -2 SD for gestational age according to the standards from Niklasson et al., 1991);
    5.Presence of anti-hGH antibodies at screening;
    6.Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, etc.;
    7.Subjects with diabetes mellitus;
    8.Subjects with impaired fasting sugar (based on WHO; fasting blood sugar > 110mg/dl or 6.1 mmol/l) after repeated blood analysis;
    9.Chromosomal abnormalities and medical syndromes (Turner’s syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, SHOX mutations/deletions and skeletal dysplasias), with the exception of septo-optic dysplasia;
    10.Evidence of closed epiphyses;
    11.Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids and methylphenidate for attention deficit hyperactivity disorder (ADHD), with the exception of hormone replacement therapies [thyroxine, hydrocortisone, desmopressin (DDAVP)];
    12.Children requiring glucocorticoid therapy, other than treated for hypothalamo-pituitary–adrenal insufficiency in replacement doses who are taking a dose of greater than 400 μg/d of inhaled budesonide or equivalents for longer than 1 month during a calendar year (e.g. asthma);
    13.Major medical conditions and/or presence of contraindication to rhGH treatment;
    14.Has a history of positive serology results to HIV, HBV and/or HCV;
    15.Subject who has a known or suspected hypersensitivity to rhGH;
    16.Other causes of short stature such as coeliac disease, hypothyroidism and rickets;
    17.The subject and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct;
    18.Subject who has received an investigational product, or has participated in a clinical study within 60 days before screening.
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY ENDPOINTS
    Primary endpoints:
    •Annualized Height Velocity in cm/year at 6 months

    SAFETY ENDPOINTS
    •Incidence of adverse events;
    •Incidence of anti-GX-H9 antibody formation (including characterization of the antibodies and neutralizing properties);
    •Local injection site assessment;
    •IGF-I levels outside (above) plus 2 SDS;
    •Parameters of glucose metabolism: blood glucose, fasting insulin level, HbA1C;
    •Thyroid status;
    •Lipid parameters;
    •Cortisol levels;
    •All other hematology and biochemical parameters;
    •Physical examination;
    •Vital signs.

    PK/PD ENDPOINTS
    Single Dose PK/PD Period
    •After GX-H9 administration: Cmax, Ctrough, Tmax, T1/2, AUC;
    •IGF-1 after GX-H9 administration: Cmax, Ctrough, Tmax, T1/2, AUC;
    •IGF-1 after Genotropin® administration: plasma concentration.
    2. Multiple Dose-Dose Finding Period
    •After GX-H9 or Genotropin® repeated dose for 3 months : Cmax, Ctrough, Tmax, T1/2, AUC, Rac - only for GX-H9;
    •IGF-1 after GX-H9 or Genotropin® repeated dose for 3 months: Cmax, Ctrough, Tmax, T1/2, AUC, Rac.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary timepoints:Annualized Height Velocity in cm/year at 6 months
    For PK/PD Endpoints:After single and after the repeated doses (the steady state)
    Safety timepoints:
    Incidence of AEs: Screening(SCR), Single dose PK/PD period(SDP),V1 to V15
    Incidence of anti-GX-H9 antibody formation:SDP,V1,V4,V5,V7,V9,V10,V12,V14,V15
    Local injection site assessment:SDP,V1 to V14
    IGF-I levels outside (above) plus 2 SDS:SDP,V1 to V14
    Blood glucose, fasting insulin level:SCR,SDP,V1 to V14
    HbA1c:SCR,V1,V3,V5,V6,V7,V8,V9,V11 to V14
    Thyroid status:SCR,V1,V3,V4,V5,V6,V7,V9,V11 to V14
    Lipid parameters:SCR,V1,V4 to V7,V9,V12,V14
    Cortisol levels:SCR,V9,V14
    All other hematology and biochemical parameters:SCR,SDP,V1,V4 to V7,V9,V12,V14
    Physical examination:SCR,V1 to V14
    Vital signs:SCR,SDP,V1-V14
    E.5.2Secondary end point(s)
    Secondary Endpoints (Auxology/Clinical/Biochemical)
    •Annualized Height velocity at 3, 6, 12 and 24 months expressed in SDS;
    •Change in height SDS at 3, 6, 12 and 24 months (compared to Baseline value);
    •Annualized height velocity at 3, 12 and 24 months expressed in cm/year;
    •Change in height at 3, 6, 12 and 24 months expressed in cm;
    •Change in absolute IGF-I levels through visits;
    •Change in IGF-I SDS through visits.

    Other exploratory endpoints:
    •Change in absolute IGFBP-3 levels through visits;
    •Change in IGFBP-3 SDS through visits;
    •Bone maturation after 12 and 24 months of treatment;
    •Predicted adult height change from start to 12 and 24 months;
    •Number of subjects needing at least one dose modification.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints (Auxology/Clinical/Biochemical)
    •Annualized Height velocity at 3, 6, 12 and 24 months expressed in SDS;
    •Change in height SDS at 3, 6, 12 and 24 months (compared to Baseline value);
    •Annualized height velocity at 3, 12 and 24 months expressed in cm/year;
    •Change in height at 3, 6, 12 and 24 months expressed in cm;
    •Change in absolute IGF-I levels through visits;
    •Change in IGF-I SDS through visits.

    Other exploratory endpoints:
    •Change in absolute IGFBP-3 levels through visits;
    •Change in IGFBP-3 SDS through visits;
    •Bone maturation after 12 and 24 months of treatment;
    •Predicted adult height change from start to 12 and 24 months;
    •Number of subjects needing at least one dose modification.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Genotropin
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Czech Republic
    Estonia
    Greece
    Hungary
    Korea, Republic of
    Lebanon
    Lithuania
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Tunisia
    Turkey
    Ukraine
    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
    LPLV (includes the follow-up visit)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    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: 48
    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: 48
    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
    Patients are between 3-11 years old and therefore not able to give
    legal consent. Parents or legal guardian will sign the informed consent.
    Patients will sign as well in case they are able to read, understand and
    sign.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 48
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-15
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