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    Summary
    EudraCT Number:2015-003108-22
    Sponsor's Protocol Code Number:PAR-C14-007
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-003108-22
    A.3Full title of the trial
    An Open-label, Single-dose Study to Determine the Pharmacokinetic/Pharmacodynamic Profile of Parathyroid Hormone (rDNA) Administered Subcutaneously at a Dose of
    50 µg in Subjects with Hypoparathyroidism Who Are 12 to Less
    Than 18 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on parathyroid hormone for use in hypoparathyroidism in children 12 to less than 18 years old.
    A.4.1Sponsor's protocol code numberPAR-C14-007
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/01/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNPS Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportNPS Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNPS Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointHjalmar Lagast
    B.5.3 Address:
    B.5.3.1Street Address550 Hills Drive, 3rd Floor
    B.5.3.2Town/ cityBedminster
    B.5.3.3Post codeNJ 07921
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019084505311
    B.5.6E-mailhlagast@shire.com
    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.2.1.1.2Name of the Marketing Authorisation holderNPS Pharma Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1210
    D.3 Description of the IMP
    D.3.1Product nameParathyroid Hormone (rDNA)
    D.3.2Product code NPSP 558
    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 INNINN Parathyroid Hormone (1-84) human
    D.3.9.1CAS number 68893-82-3
    D.3.9.2Current sponsor codeNPSP 558
    D.3.9.3Other descriptive nameParathyroid Hormone (1-84) Human Recombinant
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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.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
    Chronic hypoparathyroidism
    E.1.1.1Medical condition in easily understood language
    Hypoparathyroidism
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    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 assess the pharmacokinetic (PK)
    profile of parathyroid hormone (1-84), after administration of a single
    subcutaneous (SC) dose of 50 μg parathyroid hormone (rDNA) in
    subjects with hypoparathyroidism aged
    12 to less than 18 years.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess safety and tolerability
    of parathyroid hormone (rDNA) administration in this population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Parent/guardian or emancipated minor willing and able to provide informed consent, and minor (non-emancipated) subject willing and able to provide informed assent prior to any study-related procedures

    Subjects aged 12 to less than 18 years inclusive at the final visit (Study Day 3)

    Completed the screening process within 90 days prior to dosing

    Body weight > 30 kg

    Hemoglobin level ≥ 11 g/dL

    History of hypoparathyroidism for at least 6 months post-diagnosis, inclusive of historical biochemical evidence of hypocalcemia with concomitant serum intact parathyroid hormone (PTH) concentrations below the lower limit of the laboratory normal range

    Subjects who are treated with both oral calcium and active vitamin D must require oral calcium treatment over and above normal dietary calcium intake ≥ 500 mg/day and active vitamin D therapy at a dose of ≥ 0.5 μg/day for calcitriol or ≥ 1 µg/day for alphacalcidol.

    If a subject does not take oral calcium, the active vitamin D dosage must be
    ≥ 1 μg/day for calcitriol or ≥ 2 µg/day for alphacalcidol.
    E.4Principal exclusion criteria
    Participation in any other investigational drug study in which receipt of investigational drug occurred within 6 months prior to study entry.

    Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s)

    Known history of hypoparathyroidism resulting from an activating mutation in the calcium-sensing receptor (CaSR) gene or impaired responsiveness to PTH (pseudohypoparathyroidism)

    Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism such as active hyperthyroidism; Paget's disease; poorly controlled insulin-dependent diabetes mellitus; severe and chronic cardiac, liver or renal disease; Cushing's syndrome; neuromuscular disease such as rheumatoid arthritis; myeloma; pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy, bone metastases or history of skeletal malignancies; primary or secondary hyperparathyroidism; a history of parathyroid carcinoma; hypopituitarism; acromegaly; or multiple endocrine neoplasia types I and II

    Subjects who required parenteral calcium infusions (eg, calcium gluconate) to maintain calcium homeostasis within 3 months prior to enrollment

    E.5 End points
    E.5.1Primary end point(s)
    1) Pharmacokinetics parameters of PTH (1-84), including, e.g. Cmax and AUC
    2) Serum calcium.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 5 minutes, 1.5 and 4 hours after injection
    2) 1.5, 4, 8, 12 and 24 hours after single PTH (1-84) injection.
    E.5.2Secondary end point(s)
    Pharmacodynamics responses to recombinant parathyroid hormone including albumen, albumen corrected total serum calcium, magnesium, phosphate, 1, 25-dihydroxyvitamin D and creatinine. Safety and tolerability assessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacodynamics responses will be determined at selected timepoints from: 0, 1.5, 4, 8, 12 and 24 hours after dosing.
    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 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) Yes
    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
    Pharmacokinetic/Pharmacodynamic Profile determination
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    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 EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The start of the clinical phase is defined as first subject
    screened (FSFV). The end of the clinical phase is defined as the last
    visit of the last subject (LSLV). A follow-up telephone contact will take place approximately 30 days after discharge to enquire about any AE or SAE that could have occurred after discharge. This is not a visit.
    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 months4
    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 months4
    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: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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
    Subjects are adolescents 12 to 17.11 months of age. They need parental consent in order to take part in the study
    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 10
    F.4.2.2In the whole clinical trial 10
    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)
    After completion of the clinical trial participants will be treated according to current state of the art therapy recommendations.

    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 Decision2015-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-05
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