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    Summary
    EudraCT Number:2013-004468-69
    Sponsor's Protocol Code Number:TV1106-IMM-20001
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2014-06-02
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2013-004468-69
    A.3Full title of the trial
    A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug).
    A.4.1Sponsor's protocol code numberTV1106-IMM-20001
    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 SponsorTeva Pharmaceutical Industries, Ltd.
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries, Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street Address7, Waldeckerstr.
    B.5.3.2Town/ cityMörfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.6E-mailinfo.era-clinical@teva.de
    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 nameAlbutropin
    D.3.2Product code TV1106
    D.3.4Pharmaceutical form Powder 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 INNAlbutropin
    D.3.9.2Current sponsor codeTV1106
    D.3.9.3Other descriptive namehuman Serum Albumin (HSA) fused to somatropin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 nameAlbutropin
    D.3.2Product code TV-1106
    D.3.4Pharmaceutical form Powder 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 INNAlbutropin
    D.3.9.2Current sponsor codeTV-1106
    D.3.9.3Other descriptive nameHuman Serum Albumin (HSA) fused to somatropin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameRecombinant Human Gowth Hormone
    D.3.2Product code n/a
    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.3.9.2Current sponsor coden/a
    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 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 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 hormone deficiency
    E.1.1.1Medical condition in easily understood language
    Growth hormone deficiency (GHD) is a medical condition, caused by
    problems arising in the pituitary gland, in which the body does not
    produce enough growth hormone (GH).
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    The primary objective of this study is to determine the safety and tolerability of 3 different weekly doses of TV-1106 and a daily dose of Genotropin® in paediatric patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study is to evaluate the efficacy of 3 different weekly doses of TV-1106 and a daily dose of Genotropin® as demonstrated by height velocity (HV), height velocity standard deviation score (HV-SDS), and height standard deviation score (H-SDS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Pre-pubertal (Tanner 1/1/1) boys ≥ 3 years to ≤ 11 years and pre-pubertal girls ≥ 3 years to ≤ 10 years at time of informed consent signing with isolated idiopathic growth hormone (GH) insufficiency, GH insufficiency as part of multiple pituitary hormone deficiencies, or organic GH insufficiency (e.g., due to pituitary tumor, pituitary or brain surgery, intracranial radiation therapy);
    b. Diagnosis confirmed by 2 different GH provocation tests for GH secretion (e.g., insulin tolerance test and arginine test) as described in consensus guidelines (GH Research Society 2000, Gharib et al 2003, Rose 2007). The peak GH concentration must be below 10 ng/mL for inclusion in the study;
    c. All patients 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 patients without a history of pituitary tumor [obtained within 6 months prior to informed consent signing (Visit 1-SCR)], or
    - Patients 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 (Visit 1), 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 part of the screening procedures.
    d. H-SDS ≤ -2.0;
    e. HV-SDS <0 (minimum time between 2 standard height measurements should be at least 6 months prior to study entry; one of the measurements can be taken during the screening visit. The data should be determined from medical records and include dates and method of height measurement);
    f. IGF-I SDS < -1.0;
    g. Body Mass Index (BMI) within the 95th percentile of BMI for CA and sex according to the 2000 Centers for Disease Control (CDC) standards;
    h. For girls, normal karyotype;
    i. Written Informed Consent of the parent(s) or legal guardian of the patient and a verbal or written assent from the patients, where possible;
    j. Parent or legal guardian who is capable and willing to administer the study drug.
    E.4Principal exclusion criteria
    a. Any clinically significant abnormality as determined by the investigator, that is likely to affect growth or ability to grow (e.g., chronic diseases such as renal insufficiency or advanced diseases such as acquired immunodeficiency syndrome [AIDS] or tuberculosis; intracranial, cranio-spinal, or spinal cord irradiation; malnutrition);
    b. Contraindications to rhGH treatment;
    c. History of or currently active malignancy, including malignant intra-cranial tumors;
    d. Children with new diagnosis of pituitary/hypothalamic tumor or of intracranial tumor as confirmed by MRI or CT within 12 months prior to baseline (Visit 2-BL);
    e. Bone age, determined by the standard method (Greulich and Pyle, 1959), greater than CA or greater than 9 for girls or greater than 10 for boys within 3 months of screening. If not done within 3 months of screening, may be performed as part of screening procedures;
    f. Patients with known diagnosis of diabetes or pre-diabetes (impaired fasting glucose) as defined in the American Diabetes Association position statement (American Diabetes Association, 2013);
    g. Chromosomal abnormalities and “medical syndromes” (e.g., Noonan syndrome, Turner’s syndrome, Prader-Willi syndrome, Russell-Silver syndrome, short stature homeobox [SHOX], mutations/deletions);
    h. Skeletal dysplasias;
    i. Children born small for gestational age (SGA, defined as birth weight and/or birth length < -2 standard deviations [SDs] for gestational age);
    j. Evidence of closed epiphyses;
    k. Growth altering medications such as anabolic steroids or methylphenidate, except for pituitary replacement hormone therapy (thyroxine, hydrocortisone, desmopressin);
    l. Children requiring glucocorticoid therapy (e.g., for asthma) in excess of 400 μg/day of inhaled budesonide (or equivalents) inhaled for longer than 1 month during the last calendar year;
    m. Poorly controlled or uncontrolled pituitary hormone insufficiencies (i.e., stable therapy less than 6 months for thyroid replacement and 3 months for other hormone replacements);
    n. Hypersensitivity to the study medication components;
    o. Participation in another investigational agent trial within 30 days prior to screening;
    p. Other causes of short stature, such as celiac disease, malabsorption syndromes, untreated hypothyroidism, rickets, psychosocial dwarfism;
    q. Any medical condition as judged by the investigator to interfere with patient participation or the objectives of the study;
    r. Patients with signs and/or symptoms of increased intracranial pressure at screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable and endpoint for this study is
    HV after 6 months of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 6 months of treatment.
    E.5.2Secondary end point(s)
    The secondary efficacy variables and endpoints for this study are as follows:
    - HV at 12 months of treatment;
    - HV-SDS at 6 months and at 12 months of treatment;
    - Change in H-SDS from baseline to 6 months and 12 months of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - HV at 12 months of treatment;
    - HV-SDS at 6 months and at 12 months of treatment;
    - Change in H-SDS from baseline to 6 months and 12 months of treatment.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 EEA20
    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
    Bulgaria
    Czech Republic
    Georgia
    Greece
    Hungary
    Israel
    Poland
    Romania
    Russian Federation
    Serbia
    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
    Trial will be concluded after a follow up approximately 3 weeks after the last dose of the study drug.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 Yes
    F.1.1Number of subjects for this age range: 60
    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: 60
    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
    Patients are between 3-12 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    Patient will be referred back to his physician to evaluate need for ongoing treatment with growth hormone. Another commercially available growth hormone may be prescribed at the physician’s recommendation.
    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 Decision2014-10-17
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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