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    Summary
    EudraCT Number:2017-004545-24
    Sponsor's Protocol Code Number:ZP4207-17103
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-13
    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 number2017-004545-24
    A.3Full title of the trial
    A Randomized Trial in 2 parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Tial to evaluate the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    A.4.1Sponsor's protocol code numberZP4207-17103
    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 SponsorZealand Pharma A/S
    B.1.3.4CountryDenmark
    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 supportZealand Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZealand Pharma A/S
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressSydmarken 11
    B.5.3.2Town/ citySøborg
    B.5.3.3Post code2860
    B.5.3.4CountryDenmark
    B.5.4Telephone number4588 77 36 00
    B.5.5Fax number458877 3898
    B.5.6E-mailbba@zealandpharma.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 No
    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/3/17/1887
    D.3 Description of the IMP
    D.3.1Product nameDasiglucagon
    D.3.2Product code ZP4207
    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 INNDasiglucagon
    D.3.9.1CAS number 1544300-84-6
    D.3.9.2Current sponsor codeZP4207
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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 No
    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 placeboSolution 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
    Children with congenital hyperinsulinism
    E.1.1.1Medical condition in easily understood language
    Childrens with hereditary high level of insulin
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061211
    E.1.2Term Hyperinsulinism
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent CHI requiring continuous IV glucose administration to prevent/manage hypoglycemia.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of dasiglucagon administered as a subcutaneous (SC) infusion in patients with CHI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for trial participation if he or she meets all of the following criteria:
    1. CHI diagnosis established based on the following:
    a. Hyperinsulinemia: plasma insulin above the limit of detection of the assay
    documented during an event of hypoglycemia, and/or
    b. Hypofattyacidemia: plasma free fatty acid <1.7 mmol/L, and/or
    c. Hypoketonemia: Beta-hydroxybutyrate <1.8 mmol/L, and/or
    d. Glycemic response: an increase in PG of >30 mg/dL (1.7 mmol/L) after 1 mg IV or
    IM glucagon administration
    2. Male or female, age ≥7 days and <12 months at screening
    3. Body weight of ≥2.0 kg (4.4 lbs.)
    4. Continuous IV glucose requirement to prevent hypoglycemia
    5. One or both parents* or guardians of the patient must provide signed informed consent
    before any trial related activity is performed. (*according to local regulations)
    E.4Principal exclusion criteria
    A patient will be excluded from the trial if he or she meets any of the following criteria:
    1. Is suspected of having a transient form of CHI (e.g., transient hyperinsulinism due to
    maternal diabetes or perinatal stress)
    2. Was born preterm below 34 weeks of gestational age
    3. Presence of hypertension or hypotension, including circulatory instability requiring
    supportive medication or presence of pheochromocytoma
    4. Known or suspected presence of severe brain damage
    5. Evidence of metabolic, endocrine, or syndromic causes of hypoglycemia not due to hyperinsulinism
    6. Use of systemic corticosteroids, e.g., hydrocortisone >20 mg/m2 body surface area or equivalent within 5 days before screening
    7. Prior use of lanreotide, sirolimus (mechanistic target of rapamycin [mTOR inhibitors]), anti-inflammatory biological agents, or other immune-modulating agents. Prior use of octreotide is allowed after a minimum of 48-hour washout before randomization
    8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 X the upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR)
    <30 mL/min/1.73m2 adjusted by a pediatric formula (e.g., Schwartz formula)
    9. Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the subject’s ability to participate in the trial
    10. Known history of laboratory test results obtained before screening that show presence of HIV, hepatitis B surface antigen, hepatitis C antibody, or hepatitis A immunoglobulin M
    11. Any recognized clotting or bleeding disorder
    12. Previous administration of dasiglucagon (previously referred to as ZP4207)
    13. Known or suspected allergy to the trial drug or related products
    14. Previous participation (randomization) in the clinical program (Trials ZP4207-17103 or -17109)
    15. Has participated in an interventional clinical trial (investigational or marketed product) within 30 days of screening, or plans to participate in another clinical trial, except for 18F-Dopa PET CT/MRI investigation (where performed as a part of a research trial), which is allowed for diagnosis of focal CHI16. The use of prescription or non-prescription medications known to cause QT prolongation
    Randomization Exclusion Criteria. A screened patient will not be randomized if:
    1. Mean IV glucose requirement is <10 mg/kg/min to maintain glycemia above 70 mg/dL (3.9 mmol/L) during the previous 24 hours prior to randomization
    2. Use of glucagon within 24 hours before randomization
    3. Use of additional enteral glucose within 24 hours before randomization. Patients should be transitioned to IV glucose infusions only at least 24 hours before randomization
    4. Is not sufficiently clinically stable on IV GIR only (± diazoxide, as applicable), in the opinion of the investigator, to undergo the placebo-controlled randomized Part 1 of the
    trial (2x48 hours)
    E.5 End points
    E.5.1Primary end point(s)
    Part 1 (Day 1 to 4)

    - Mean IV GIR in the last 12 hours of each treatment period during Part 1 (dasiglucagon or placebo administration)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Period from 36h to 48 h and from 84h to 96h after the start of study treatment
    E.5.2Secondary end point(s)
    Part 1 (Day 1 to 4, for each 48-hour treatment period)
    - Total amount of carbohydrates administered (via IV infusion, NG tube, gastrostomy, or oral route) per day
    - Hypoglycemia event rate, defined as number of hypoglycemic events (PG <70 mg/dL or 3.9 mmol/L), as detected by self-monitored plasma glucose
    (SMPG)
    - CGM percent time in range 70-180 mg/dL (3.9-10.0 mmol/L)
    - Clinically significant hypoglycemia event rate, defined as number of events <54 mg/dL (3.0 mmol/L), as detected by SMPG
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Continously during each 48 hour period of Part 1 (day 1-2 and day 3-4)
    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 Yes
    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) 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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Period 1 (24 hrs): Randomised Test drug versus PLacebo. Period 2 (4 weeks): Open label-Test drug
    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.8.2.4Number of treatment arms in the trial2
    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 EEA3
    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
    Germany
    Israel
    United Kingdom
    United States
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 12
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 4
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 12
    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 Treatment Period 2, patients who are ineligible for surgery, and who do not have a clearly defined and potentially surgically treated focal form of CHI may be eligible to enter a long-term extension trial (Trial ZP4207-17106) to continue dasiglucagon treatment. Patients who do not enter the long-term extension trial will return to standard of care as per investigator discretion. No further treatment with dasiglucagon will be offered.
    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 Decision2019-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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