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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41210   clinical trials with a EudraCT protocol, of which   6750   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2012-004263-47
    Sponsor's Protocol Code Number:EMR200104-011
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-05
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2012-004263-47
    A.3Full title of the trial
    Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD).
    Otevřená, jednoramenná, multicentrická studie fáze IV zkoumající imunogenicitu tekuté formy přípravku Saizen® u subjektů s nedostatečností růstového hormonu (AGHD) v dospělosti.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploration if Saizen marketed solution for injection induces an immunogenic reaction
    A.3.2Name or abbreviated title of the trial where available
    Saizen, Phase 4 study in Growth Hormone Deficiency
    A.4.1Sponsor's protocol code numberEMR200104-011
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merck.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 Yes
    D.2.1.1.1Trade name SAIZEN
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Ltd.
    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 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 nameSOMATROPIN
    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 number5.83
    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
    Adult Growth Hormone Deficiency
    E.1.1.1Medical condition in easily understood language
    Adult Growth Hormone Deficiency
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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 determine whether the marketed Saizen solution for injection, administered according to the approved label for 9 months (39 weeks) in adults with GHD, induces the development of binding antibodies (BAbs).
    E.2.2Secondary objectives of the trial
    Determine the proportion of subjects having developed BAbs who also developed neutralizing antibodies (NAbs).

    Assess the overall pharmacodynamic profile (insulin-like growth factor type I [IGF-I]; insulin-like growth factor binding protein type 3 [IGFBP-3]; IGF-I standard deviation score [SDS]) in subjects with or without antibodies.

    Assess the safety of Saizen® solution for injection through the evaluation of treatment-emergent adverse events (TEAEs), physical examination, weight, blood pressure (BP), and heart rate (HR) changes, and changes in laboratory parameters.

    Calculate treatment adherence using the easypod™ connect software application.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects, 18-65 years of age, inclusive, at the time of signature of informed consent.
    2. Documented AGHD, i.e. childhood onset (CO) or adult onset (AO), either by a stimulation test as described in the GH Research Society’s 2007 guidelines for the diagnosis and treatment of adult GHD, or in the Saizen® label, whichever is more stringent, or by confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-I level below the reference range of the laboratory where testing is performed.
    Stimulation test as described in the 2007 GH Research Society guidelines and applicable to all subjects who underwent or will undergo a stimulation test:
    Insulin Tolerance Test (ITT) or glucagon stimulation test: peak GH < 3 ng/mL;
    GHRH + arginine test, peak GH depends on BMI:
    · BMI < 25 kg/m2 à a peak GH <11 ng/mL (mg/L);
    · BMI 25–30 kg/m2 à a peak GH < 8 ng/mL (mg/L);
    · BMI > 30 kg/m2 à a peak GH < 4 ng/mL (mg/L).
    Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for determining eligibility in this trial.
    Stimulation tests remain under the Investigator’s or the subject’s physician’s responsibility, including the selection of the GH assay.
    Saizen® label: in Europe, only one single test is required; in Australia, 2 stimulation tests showing a peak GH < 2.5 ng/mL are required. The inclusion criteria were chosen based on the approved label for Saizen® in the countries where the trial is being implemented, as well as in respect of the most current international guidelines for AGHD. There is no limit in time prior to the Screening visit for the stimulation test(s), as long as documentation is available and the stimulation tests comply with the GH Research Society 2007 guidelines, and as such, there is no need to repeat the test for subjects having stopped their GH therapy prior to the Screening visit.
    No stimulation test is required for subjects with 3 or more pituitary hormone deficiencies.
    3. GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to Screening visit.
    Whereas any prior use of GH is permitted, providing an adequate wash-out period is respected to secure the interpretation of the biomarkers, the reason for stopping the GH therapy should neither be safety- nor efficacy-related, and documentation should be present in the source information.
    4. Negative BAbs from the Screening visit sample.
    5. Body mass index (BMI) measured at the Screening visit (Weight in kilograms / [Height in meters]2) ≤ 40 kg/m2.
    6. Negative serum pregnancy test at the Screening visit for women of childbearing potential and subject is not lactating.
    7. Understanding and willingness of the subject to comply with the procedures of the study.
    8. Informed Consent form signed prior to the performance of any trial-related activities.
    E.4Principal exclusion criteria
    Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria:
    1. Hypersensitivity to the active substance or to any of the Saizen® excipients.
    2. Evidence of growing intracranial tumor including pituitary tumor, or affecting the optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior to and the 12 months after the Screening visit.
    3. Presence of active malignancy, neoplasia or any evidence of progression or recurrence of an underlying tumor. In case of a history of neoplasia or any pre-existing malignancy, the tumor must be inactive and anti-tumor therapy completed prior to starting trial on active Saizen
    therapy.
    4. Proliferative or preproliferative diabetic retinopathy.
    5. Evidence of chronic underlying disease within 6 months prior to the Screening visit or concomitant medication that would interfere with subject compliance, the evaluation of trial results, or compromise the safety of the subject.
    6. Severe hepatic or renal failure that could compromise the interpretation of IGF-I, i.e.:
    · Alanine transaminase [ALT] or aspartate transaminase [AST] > 3 x upper limit of the normal range;
    · Glomerular filtration rate (GFR) < 30 mL/min.
    Note: GFR will be calculated by the laboratory according to the Modification of Diet in Renal Disease (MDRD) equation
    7. History of anti-GH antibodies,
    8. History or presence of an autoimmune disease, such as Hashimoto’s disease or Systemic Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene defect.
    9. Absence of effective contraception in place at the Screening visit in women of childbearing potential.
    Acceptable forms of effective contraception include: established use of oral (> 2 months), injected, or implanted hormonal methods of contraception, intrauterine devices (IUD), or barrier methods of contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    10. Diabetes mellitus (per American Diabetes Association 2010 uidelines): either i) standard diabetes symptoms and a random glucose
    ≥200 mg/dL (11.1 mmol/L); ii) a fasting plasma glucose > 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT); or iv) an glycosylated hemoglobin (HbA1c) ≥ 6.5%.
    11. Concomitant or prior participation in an interventional trial within 30 days prior to the Screening visit.
    12. Known alcohol or drug addiction/dependency.
    13. Has a legal incapacity or limited legal capacity.
    14. Has received anabolic steroids (except for gonadal steroid replacement therapy) or systemic corticosteroids (except for replacement doses) within 3 months prior to the Screening visit.
    15. Has received substitutive therapy with glucocorticosteroids, thyroid replacement, vasopressin, or sex hormones for < 3 months or substitutive therapy has not been stable (i.e., dose was not generally constant or medical condition was not controlled) for the 3 months prior to Screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is the proportion of subjects developing BAbs to Saizen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Any time during the 39-week course of treatment.
    E.5.2Secondary end point(s)
    ·proportion of subjects with BAbs who become positive for NAbs,· effects of Saizen® on the GH biomarker IGF-I, IGFBP-3, IGF-I SDS, and
    adherence to treatment using easypod connect.
    Safety endpoints include TEAEs, physical examination, weight, BP, HR, and laboratory parameters exploring lipid and glucose metabolism, as well as thyroid function.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Any time during the 39-week course 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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Australia
    Czech Republic
    Germany
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    This trial will be considered as completed at the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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: 77
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 77
    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 Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-21
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