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    Summary
    EudraCT Number:2005-000384-26
    Sponsor's Protocol Code Number:BPLG-005
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-02
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2005-000384-26
    A.3Full title of the trial
    A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.
    A.4.1Sponsor's protocol code numberBPLG-005
    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 SponsorBioPartners GmbH
    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 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.3.2Product code LB03002
    D.3.4Pharmaceutical form Powder and solvent for suspension 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.3.9.2Current sponsor codeLB03002
    D.3.9.3Other descriptive namerecombinant human growth hormone (rhGH)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Growth hormone deficiency in adults
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level PT
    E.1.2Classification code 10056438
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate a clinical superiority of LB03002 over placebo in terms of improvement in fat mass (FM) in adult patients with GHD.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine the efficacy of LB03002 over placebo in other body composition variables, biochemical markers, lipid profile and qualify of life (QoL) score. In addition, safety and tolerability features of LB03002 will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female of at least 23 years and not more than 70 years of age.
    2) GHD of either adult onset (AO), resulting from pituitary ablation or failure which have occurred at least 1 year before study entry, with diagnosed deficiency of at least one other pituitary hormone other than prolactin, or childhood onset (CO), either idiopathic or secondary to pituitary disease.
    3) Confirmed diagnosis of GHD defined as one of the following:
    i) Negative response to either an insulin tolerance test (ITT) or an arginine plus GH-releasing hormone test (ARG-GHRH) [Tests performed within the last 5 years are acceptable if it can be verified from source data. In addition, for CO patients, the test should be after the age of 20 years or completion of growth.]
    Or:
    ii) Three or four other pituitary hormone deficiencies at screening.
    4) IGF-I SDS ≤ -1 at screening (see Appendix 3 for IGF-I SDS calculation)
    5) No exposure to rhGH within the last 6 months.
    6) Patients with adequate adrenal function, which is confirmed by ACTH stimulation test at screening;
    Or:
    Patients with known secondary hypoadrenalism on adequate glucocorticoid replacement therapy.
    7) If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 3 months before study entry. For patients receiving estrogen, the route of treatment should be maintained throughout the study. Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is acceptable.
    8) Women of child-bearing potential to be using a reliable method of contraception at the screening and be willing to use it throughout the study (Female patients of normal gonadal function receiving oral contraceptives are required to be on stable therapy for at least 3 months before study entry). A negative serum pregnancy test is required at screening for females of child-bearing potential.
    9) Written informed consent of the patient.
    E.4Principal exclusion criteria
    1) History of malignancy other than i) cranial tumor or leukemia causing GHD or ii) fully treated basal cell carcinoma.
    2) Evidence of active malignancy.
    3) Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months, or patients without MRI or CT data to confirm the tumor stability within the last 12 months. (footnote: An additional MRI or CT scan will be conducted to confirm the tumor stability if a patient meets other inclusion and exclusion criteria, but DOES NOT have MRI or CT data within last 12 months to confirm the tumor stability.)
    4) Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >2 x upper limit of normal).
    5) Chronic renal impairment (serum creatinine >1.6 mg/dL).
    6) Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease.
    7) Prader-Willi syndrome.
    8) Acute severe illness in the last 6 months.
    9) Benign intracranial hypertension.
    10) Active Cushing’s syndrome within the last 12 months.
    11) Active acromegaly within the past 12 months.
    12) Uncontrolled hypertension.
    13) Patients with overt diabetes mellitus (fasting glucose level >126 mg/dL) or evidence of persistent impaired glucose tolerance (fasting glucose level >100 mg/dL at screening and history of impaired glucose tolerance in the source documents. If a fasting glucose level >100 mg/dL is detected at screening but there is no history of impaired glucose tolerance, then an additional test will be done at least 1 week later to exclude any false or temporary impaired glucose tolerance. If a normal result is obtained from the additional test, the patient will be considered eligible for the study).
    14) Severe psychiatric disease or patients who cannot understand the objective and methods of the study or patients with current alcohol abuse.
    15) Pregnancy or lactation.
    16) Known hypersensitivity to any ingredient of the study drug: rhGH, sodium hyaluronate, lecithin, dibasic sodium phosphate, monobasic sodium phosphate, medium chain triglycerides.
    17) Inability to undergo scanning by dual-energy X-ray absorptiometry (DXA) due to a body weight more than 130 kg or in situ internal or external devices known to interfere with DXA scanning
    18) Weight reducing drugs or appetite suppressants (a 6-month withdrawal period is required unless it can be documented that no weight loss occurred with these drugs, in which case a 3-month withdrawal period is sufficient).
    19) Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry.
    20) Methylphenidate within 2 months before study entry
    21) Systemic corticosteroids other than in replacement doses within the 3 months before study entry. Temporary adjustment of glucocorticoids, as appropriate, is acceptable.
    22) History of non-compliance with medications, un-cooperativeness or drug abuse.
    23) Patients participating in another study parallel to, or within 6 months prior to study entry, or previous participation in this study.
    24) Patients who are not able to comply with the study protocol for any reason.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: The primary efficacy endpoint will be the FM change at Visit 8 (4±1 days after dose 26) from baseline.

    Safety endpoints:
    * Incidence of adverse events;
    * Incidence of anti-human growth hormone antibody formation after 26 weeks of treatment;
    * Incidence of anti-Saccharomyces cerevisiae antibody formation after 26 weeks of treatment;
    * Local tolerability assessment by investigator and patients;
    * Glucose homeostasis parameters: fasting glucose, fasting insulin and fasting glycosylated hemoglobin (HbA1C);
    * Thyroid function tests: free triiodothyronin (fT3), free thyroxin (fT4),thyroid stimulating hormone (TSH);
    * Adrenal function test: serum cortisol, adrenocorticotropic hormone (ACTH) stimulation test;
    * IGF-I SDS, IGF-I SDS minus IGFBP-3 SDS;
    * Laboratory safety parameters
    * Vital signs;
    * Physical examination.
    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 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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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 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
    Last patient last visit.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-02. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The ICF must be signed and personally dated by the patient. A witness or legal representative is required for those patients who cannot consent alone.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 150
    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)
    Those patients that complete the main study (BPLG-005) and are willing to continue their participation in an extension study will be invited into a rollover study (BPLG-005-RO), where all patients will receive LB03002 for 26 weeks following a transition period. The main objective of this rollover study is to evaluate the long-term safety of LB03002.
    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 Decision2005-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-04
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