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    Summary
    EudraCT Number:2011-001826-61
    Sponsor's Protocol Code Number:11‐HM10560A‐201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-12
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2011-001826-61
    A.3Full title of the trial
    A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency
    A.4.1Sponsor's protocol code number11‐HM10560A‐201
    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 SponsorHanmi Pharmaceutical Co., Ltd.
    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 supportHanmi Pharmaceutical Co., Ltd.
    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
    B.5.2Functional name of contact pointClinical Trials Info
    B.5.3 Address:
    B.5.3.1Street Address103 Haros Str
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1222
    B.5.3.4CountryHungary
    B.5.4Telephone number+3612990091
    B.5.5Fax number+3612990096
    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 nameHM10560A
    D.3.2Product code HM10560A
    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.3.9.2Current sponsor codeHM10560A
    D.3.9.3Other descriptive namechemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.5
    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 Yes
    D.3.11.13.1Other medicinal product typeHM10560A is highly purified chemical conjugate of recombinant human growth hormone [rhGH] and HMC001 [constant region of human immunoglobulin fragment] linked via a non‐peptidyl 3.4 kDa PEG linker
    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.3.4Pharmaceutical 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.3.9.1CAS 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 number5.3
    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
    Adult growth hormone deficiency (AGHD)
    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 18.0
    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
    1.To assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week(EOW) regime administered for a period of 24 weeks initial study
    2.To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment
    3.To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.
    GHDA subjects, males and females, of age between 23 and 65 years with childhood or adult onset, as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone use in Growth Hormone‐Deficient Adults and Transition Patients (2009).
    2.
    rhGH drug naive or any registered or investigational rhGH replacement therapy was not given for more than 6 months before the screening.
    3.
    Patients on stable hormonal replacement therapies for deficiencies of other hypothalamo‐pituitary axes must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening. Temporary adjustment of glucocorticoid replacement therapy, as appropriate,is acceptable.
    4.
    Screening IGF‐I level of at least 1 SD (IGF‐I SDS<‐ 1) below the mean IGF‐I level standardized for age and sex according to the central laboratory reference values.
    5.
    Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
    6.
    Fertile females must agree to use appropriate contraceptive methods during the study and 20 days after the last dose of study medication.
    7.
    Female patients must have a negative serum pregnancy test at inclusion.
    8.
    Confirmed to be negative for anti rhGH antibodies at the time of screening.
    9.
    Willing and able to provide written informed consent prior to performing any study procedures.
    E.4Principal exclusion criteria
    1.
    Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months which has to be confirmed by computer tomography (CT) or magnetic resonance imaging (MRI) scan (with contrast) within 3 months prior to screening. (Patients with inactive remnant intracranial tumors are eligible).
    2.
    History of malignancy other than i) cranial tumor or leukemia causing GHD or ii) fully treated basal cell carcinoma or evidence of active malignancy.
    3.
    Current antitumor therapy.
    4.
    Subjects presenting with any clinically significant ECG abnormality.
    5.
    Evidence of intracranial hypertension.
    6.
    Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >1.5 x upper limit of normal).
    7.
    Significant renal impairment as indicated by serum creatinine levels above the normalized range for age.
    8.
    Any other major medical conditions, including e.g., clinically manifest diabetes mellitus, hypertension, tuberculosis, major surgery within the last three months before screening, or significantly abnormal laboratory tests (e.g., disturbed calcium homeostasis); or any other conditions (e.g., acute infections) that may influence drug absorption, metabolism or excretion or that may interfere with any study variables in the judgment of the investigator.
    9.
    Systemic corticosteroids other than in replacement doses within the 3 months before screening. (Temporary adjustment of glucocorticoids, as appropriate, is acceptable).
    10.
    Pregnancy and breastfeeding
    11.
    Anabolic steroids other than gonadal steroid replacement therapy within
    2 months before screening. Per‐oral estrogen replacement and hormonal
    contraceptives are not allowed. For replacement purposes, transdermal
    estrogens are permitted in female patients.
    12.
    History of non‐compliance with medications, un‐cooperativeness or
    alcohol/drug abuse.
    13.
    Positive results from serology examination for HBV, HCV or HIV.
    14.
    Known or suspected hypersensitivity to the study treatment.
    15.
    Blood donation or any major blood loss >500 mL within the past 90 days
    prior to screening.
    16.
    History of any medical or psychiatric condition that in the opinion of the
    investigator would pose a risk for participation in this study or interfere
    with the compliance needed for this study.
    17.
    Received an investigational drug or product, or participated in a drug
    study within 30 days before Screening.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoints: Change of IGF‐I levels in function of time, and dose strengths
    E.5.1.1Timepoint(s) of evaluation of this end point
    on week 2,4,8,12,16,20,24,28,32,36,40,44,48,56,64,72,74
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    Biochemical endpoints (IGF‐I andIGFBP3 will also serve as pharmacodynamic endpoints):
    Main biochemical endpoints
    1)IGF‐I SDS; changes to baseline in IGF‐I SDS;
    2)IGFBP3, IGFBP3 SDS (actual values and SDS changes to baseline)
    Exploratory biochemical endpoints
    1)Lipid parameters (Total Cholesterol, LDL, HDL, Lp(a) Lipoprotein, triglycerides; actual values and changes to baseline)
    Clinical endpoints:
    Main Clinical endpoints
    1)Change in lean body mass (LBM) expressed in kg‐s; from the baseline to the end of study (as measured with DXA)
    2)Change in body fat mass (FM) expressed in kg‐s from the baseline to the end of study as measured with DXA
    3)Relative change in body fat,
    4)Change in trunk fat (kg‐s)
    5)Relative change in trunk fat
    6)Change in bone mineral density
    Exploratory clinical endpoints
    1)Change in waist circumference
    2)Change in hip circumference
    3)Change in waist‐to‐hip ratio
    4)Change in sum of skinfolds thickness
    5)Change in BMI
    6)Change in QoL (SF‐36) scores
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main biochemical endpoints on week 2,4,8,12,16,20,24,28,32,36,40,44,48,56,64,72,74
    Exploratory biochemical endpoints on week 4,12,24,36,48,74
    Main clinical endpoints on week 12,24,48,74
    Exploratory clinical endpoints on week 12,24,48,74
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Bulgaria
    Hungary
    India
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Serbia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Yes
    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.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 65
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-29
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