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    The EU Clinical Trials Register currently displays   41225   clinical trials with a EudraCT protocol, of which   6755   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-004975-37
    Sponsor's Protocol Code Number:TV1106-GHD-201
    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:2013-07-09
    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 number2012-004975-37
    A.3Full title of the trial
    A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).
    A.4.1Sponsor's protocol code numberTV1106-GHD-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 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 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 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 Growth 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 16.0
    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 evaluate the clinical effect of weekly doses of TV-1106, as measured by the change from baseline in IGF-I, in GHD adults following 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
     To assess the extent of the adult GHD patient population that responds positively to weekly TV-1106 as demonstrated by an increase in IGF-I standard deviation score (SDS)
     To determine the effect of long-term TV-1106 treatment on maintenance of or improvement in the lipid profile of adult GHD patients treated with TV-1106 for 64 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.) Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator.
    2.) Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary disease or due to genetic causes.
    3.) Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing specified by an accepted guidance (e.g., GH Research Society Consensus guidelines for the diagnosis and treatment of adults with GH deficiency 2007; AACE Clinical Practice Guidelines 2009; Endocrine Society Clinical Practice Guidelines Molitch et.al. 2006 and 2011) in effect at the time of
    diagnosis.
    E.4Principal exclusion criteria
    1.)Patients with history or clinical evidence of active or chronic diseases
    that could confound results of the study or put the subject at undue risk
    as determined by the investigator.
    2.) Patients with known active malignancy
    3.) Patients with history of malignancy other than intracranial tumor
    causing GHD (excluding surgically cured basal cell or squamous cell
    cancer of the skin with documented 6 month remission)
    4.) Patients with a new diagnosis of pituitary adenoma or other
    intracranial tumor within 12 months of baseline (Visit 3)
    5.) Presence of Prader-Willi syndrome, Turner's syndrome, untreated
    adrenal insufficiency, active acromegaly in the past 5 years, or active
    Cushing's syndrome in the past 1 year.
    6.) Patients with known history of severe allergic or anaphylactic
    reactions
    7.) Patients with known allergy or hypersensitivity to rhGH, HSA, yeastderived
    products, or any other component of the formulation
    8.) Patients with antibodies to hGH following the washout period.
    9.) Patients who will require a dose of the study drug (TV-1106) in
    excess of 50 mg/week or of Genotropin® in excess of 1.8 mg/day at
    baseline visit.
    10.) Patients who have had 1 of the following conditions in the noted
    amount of time prior to screening or between screening and first dosing
    day: major trauma or surgery within 6 months; acute infection requiring
    systemic antibiotic treatment within 4 weeks; any acute, severe illness
    within 6 months
    11.) Patients with history of documented increased intracranial pressure
    (ICP) associated with GH treatment or signs of increased ICP including
    papilledema based on fundoscopic exam performed by investigator or
    ophthalmologist during screening.
    12.) Patients who have participated in another clinical trial with a new
    chemical/biological entity within 3 months of screening
    13.) Patients who have clinically significant abnormal electrocardiogram
    (ECG) as determined by the investigator
    14.) Patients with blood pressure (treated) outside the ranges 90 to 139
    or mHg systolic or 45 to 89 mmHg diastolic, inclusive.
    15.) Patients with abnormal levels [greater than x2 the upper limit of
    normal (ULN)] of alanine aminotransferase (ALT), gamma-glutamyl
    transpeptidase (GGT) or total bilirubin at screening or baseline
    16.) Patients with known history of or confirmed positive test results for
    human immunodeficiency virus (HIV) types 1 and 2 at screening
    17.) Patients with known history of or a positive test result for hepatitis
    B (HBsAg) or hepatitis C virus (HCV) at screening
    18.) Patients using weight reducing agents or appetite suppressants.
    19.) Patients with persistent or recurring migraines, clinically important
    edema as assessed by the investigator history or presence ofcarpal
    tunnel syndrome, paresthesias, or other nerve compression symptoms.
    20.) Patients with diagnosis of diabetes mellitus or patients with
    impaired fasting blood glucose (100 – 125 mg/dL, inclusive).
    21.) Women who are pregnant or nursing at the time of screening or
    who intend to be during the study period.
    22.) Patients who use anabolic steroids or corticosteroids except for
    physiological maintenance doses used as treatment for patients with
    hormone deficiencies. Limited use of low dose glucocorticoid
    preparations is allowed (eg. skin creams, eyedrops).
    Inhaled budesonide will be permitted at a monthly consumption not to
    exceed 400 μg/day for 3 days (total 1200 μg/month).
    23.) Patients with a malignant appearing skin lesion unless it has been
    evaluated by a dermatologist and confirmed to be non-malignant.
    24.) Patients with history of alcoholism or with history or evidence of
    drug/chemical abuse unless the patient has recovered from the
    addiction for at least 10 years. Recovery is defined when an individual
    achieves abstinence and improved health, wellness and quality of life as
    confirmed by the investigator.
    25.) Patients with a psychological condition which may influence compliance with the study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for this study is IGF-I
    concentration (ng/ml). The primary endpoint is the change from baseline in IGF-I SDS to Cmax
    level during week 12, for patients treated with TV-1106.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during week 12
    E.5.2Secondary end point(s)
    The secondary efficacy variables and endpoints for this study are as follows:
    1. The percentage of patients, treated with TV-1106, who return by the trough level of
    IGF-I SDS during study week 12 to their pre-washout (screening) IGF-I SDS level
    (± 0.5 SDS) and their Cmax level during week 12 is below +2.0 SDS.
    2. Lipid profile assessed by measurement of lipoprotein (a), triglycerides and LDL,
    HDL, and total cholesterol after 64 weeks of TV-1106 treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.The percentage of patients, treated with TV-1106, who return by the trough level of
    IGF-I SDS during study week 12 to their pre-washout (screening) IGF-I SDS level
    (± 0.5 SDS) and their Cmax level during week 12 is below +2.0 SDS.
    2.Lipid profile assessed by measurement of lipoprotein (a), triglycerides and LDL,
    HDL, and total cholesterol after 64 weeks of TV-1106 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 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 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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Czech Republic
    Germany
    Greece
    Hungary
    Slovakia
    Slovenia
    Sweden
    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 telephone follow up two weeks after the final 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 months1
    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 months1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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 Decision2013-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-06-22
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