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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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    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:2010-023430-23
    Sponsor's Protocol Code Number:EMR701048_009
    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:2010-11-25
    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 number2010-023430-23
    A.3Full title of the trial
    A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD)
    A.4.1Sponsor's protocol code numberEMR701048_009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Serono S.A.
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.2.1.2Country which granted the Marketing AuthorisationCanada
    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 nameSaizen
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number6 to 12
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typesomatropin is produced by recombinant DNA technology (genetically engineered mammalian cells (mouse C127)).
    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
    This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the immunogenicity of the r-hGH liquid multidose formulation (SaizenÒ solution for injection) by measuring the proportion of subjects who become positive for binding antibodies (BAbs+) during a 6-month (26-week) course of daily GH replacement therapy in adult subjects with documented GHD (either idiopathic or acquired and childhood- or adult-onset).
    E.2.2Secondary objectives of the trial
    To evaluate the proportion of adult subjects with GHD who become positive for neutralizing antibodies (NAbs+), only if those same samples were already determined to have been positive for binding antibodies (BAbs+).

    To assess the effect of Saizen solution for injection on GH biomarkers (IGF-I and IGFBP-3).

    To assess the safety profile of Saizen solution for injection, via TEAEs, vital signs, physical examinations, and laboratory results, including GH biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male and female subjects, 18-60 years of age, inclusive, at the time the Informed Consent is signed.

    2. Subject satisfies any of the following conditions in relation to GH deficiency:
    a. Is GH treatment-naïve
    b. Had received Saizen (freeze-dried formulation) for PGHD
    c. Has or had received Saizen (freeze-dried formulation) for AGHD and either:
    i. Had discontinued Saizen for reasons other than safety, tolerability, or efficacy; or
    ii. Is currently being treated with Saizen for at least 3 consecutive months prior to Screening.

    3. For GH treatment-naïve subjects or subjects previously treated with Saizen (freeze-dried formulation) for PGHD and not currently on Saizen for AGHD, subjects, must have confirmed AGHD before initiating study treatment (Saizen solution for injection), as documented by GH provocative testing described below. The peak GH level needs to be less than the pre-determined cutoff value in one of the following GH provocative/stimulation tests (per the GH Research Society’s 2007 guidelines for the diagnosis and treatment of adult GHD). (30) Note: If more than 2 tests are performed, all peak GH levels should be less than the following, predetermined cutoff values:
    · <3 ng/mL for a peak GH level if an Insulin Tolerance Test (ITT) or a glucagons stimulation test is performed.
    · If a GHRH + arginine test is performed, the following cutoff levels have been validated:
    · 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).

    4. Subjects who had previously undergone or are currently undergoing treatment for adult GHD with Saizen® freeze-dried formulation prestudy must have shown evidence of treatment responsiveness and compliance by either (i) an IGF-I SDS >0.0 during treatment, or (ii) an increase of at least 1 SD in IGF-I levels, relative to what those levels were prior to initiating Saizen® freeze-dried treatment. Note: The Sponsor will make every effort to provide each site with appropriate, normative IGF-I SDS tables/standards.

    5. All subjects, i.e., both GH treatment-naïve and those who had been receiving or are currently receiving Saizen® freeze-dried formulation for adult GHD must undergo a blood sampling for binding antibodies (BAbs) to GH and must be binding antibody-negative (BAbs-) for the Screening visit sample. NOTE: Study sites should make every effort to obtain at least samples for antibody testing within a window of 21-28 days prior to the anticipated start of study treatment on Day 1 in order to ensure that the antibody results will be available from the central laboratory(ies) prior to the planned initiation of treatment.

    6. No evidence of concomitant disease, intercurrent illness, or resultant therapy that would interfere with subject compliance, the evaluation of study results, or compromise the safety of the subject.

    7. Has no history of GH antibodies, autoimmune disease, or GH1 gene defect.

    8. Euthyroid with or without therapy at Screening.

    9. Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit (and at each scheduled visit during the study). NOTE: To qualify for entry into the study, women must be either surgically sterile or post-menopausal or, if capable of conceiving, use appropriate contraceptive measures from at least 2 months prior to the Screening visit through Study Day 1 and during the entire 6 months (26 weeks) of study treatment and for the 4 weeks off-treatment, until the 1-month, post-treatment, follow-up clinic visit is completed. See also Sections 6.5.1.1, and 7.4.2.

    10. Willingness of the subject to comply with the procedures of the study; and

    11. Willingness of the subject to sign an IEC/IRB-approved Informed Consent form.
    E.4Principal exclusion criteria
    1. Is currently receiving or has previously received treatment for adult GHD or any other indication, including PGHD, with a commercial GH product other than Saizen freeze-dried formuation.

    2. Had a chronic underlying disease within 6 months prior to Screening or concomitant medication(s) that in the opinion of the Investigator would exclude the subject from the trial (i.e., could interfere with the safety of the subject, evaluation of study data, etc.).

    3. Has chronic liver disease documented in medical history.

    4. Has alanine transaminase [ALT] or aspartate transaminase [AST] > 2.5 x upper limit of the normal range, unless permitted by sponsor medical responsible.

    5. Has significant renal impairment, as indicated by a glomerular filtration rate (GFR) <60 mL/min.

    6. Has diabetes mellitus (per American Diabetes Association 2010 guidelines): either (i) standard diabetes symptoms and a random glucose ³ 200 mg/dL (11.1 mmol/L); (ii) a fasting plasma glucose > 126 mg/dL (6.99 mmol/L); (iii) a plasma glucose ³ 200 mg/dL (11.1 mmol/L) during an OGTT); or (iv) an HbA1c ≥ 6.5%.

    7. Has a current malignancy or a history of any malignancy (excluding fully-treated basal cell carcinoma).

    8. Has craniopharyngioma or another intracranial benign neoplasm in remission for less than one year.

    9. Has participated in another study and received an investigational drug within 30 days prior to Screening visit.

    10. Is positive for HIV, hepatitis B surface antigen, or hepatitis C at Screening or by documentation from within 3 months prior to Screening.

    11. Is immunosuppressed or receiving immunosuppressive therapy.

    12. Has a known alcohol or drug addiction/dependency.

    13. Has active Cushing’s disease, Prader Willi syndrome, benign intracranial hypertension (or a history of that condition), a history of acromegaly, or signs and symptoms suggestive of transmissible spongiform encephalopathy.

    14. Has a serious psychiatric illness or inability to understand the study, i.e., the subject must fully understand the study and the importance of attending scheduled clinic visits.

    15. Has a legal incapacity or limited legal capacity.

    16. Has received anabolic steroids (except for gonadal steroid replacement therapy) or systemic corticosteroids (except for replacement doses) within 3 months prior to Screening.

    17. Has a clinically significant abnormal laboratory value(s) at Screening or Day 1, per the Investigator’s or Sponsor’s Medical Responsible (or qualified designate’s) clinical judgment.

    18. Has a known hypersensitivity or allergy to exogenous human growth hormone or any of the excipients or phenol, the bacteriostatic agent in the SaizenÒ solution for injection cartridges to be used in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study will be the proportion of adult subjects with GHD who develop binding antibodies (BAbs+) to Saizen solution for injection at any time during a 26-week (6-month) course of single daily SC injections.
    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 No
    E.6.6Pharmacokinetic No
    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
    immunogenicity
    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 Yes
    E.7.1.3.1Other trial type description
    open-label
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    all enrolled subjects who have received at least one dose of study drug have completed all scheduled visits (including all prematurely discontinued subjects who should undergo at least the Week 26/End of Treatment (+ one-month post-treatment follow-up visits if the subject is willing to do so);
    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 months6
    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 months6
    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.1.3Elderly (>=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 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 50
    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 Decision2011-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
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