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    The EU Clinical Trials Register currently displays   41231   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-004547-21
    Sponsor's Protocol Code Number:ZP4207-17109
    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:2018-05-31
    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 number2017-004547-21
    A.3Full title of the trial
    A Two-Period, Open-label Trial 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 numberZP4207-17109
    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-mailBBandak@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 in administration system
    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 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 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
    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 administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with Congenital Hyperinsulinism.
    E.2.2Secondary objectives of the trial
    -To evaluate the safety and tolerability of dasiglucagon administered as an SC infusion in children with CHI
    -To evaluate the efficacy of dasiglucagon in reducing glucose requirements
    -To investigate quality of life and resource utilization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Established and documented diagnosis of CHI based on standard of care.
    2. Male or female between 3 months and 12 years of age (both inclusive) at screening.
    3. Has a negative serum pregnancy test at screening/baseline (only for girls of childbearing potential).
    4. Sexually active female patients (and their partners) must continue to use acceptable contraception or refrain from sexual activity from screening until 30 days after the last dose of trial drug. Females must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception. Abstinence can only be accepted if this is true abstinence in line with the preferred and usual lifestyle of the patient.
    Acceptable methods of contraception are:
    a) Hormonal contraceptives (e.g., oral contraceptive pill, depot, patch, intramuscular implant or injection, sponge, or vaginal ring), stabilized for at least 30 days if first use
    or
    b) Barrier method, e.g., (i) condom (male or female) and (ii) diaphragm with spermicide
    5. Experiencing ≥3 events of hypoglycaemia per week (PG <70 mg/dL [<3.9 mmol/L]) according to the investigator’s evaluation.
    6. Following receipt of oral and written information about the trial, the patient (depending on local IRB/IEC requirements) must provide assent and one or both parents* or guardians of the patient must provide signed informed consent before any trial-related activity is carried out.
    7. Previously undergone near-total pancreatectomy or being treated with a non-surgical approach, having been evaluated as not eligible for pancreatic surgery
    8. If somatostatin analogues or sirolimus are used, the therapy should be well established as judged by the investigator, especially when considering their biological half-life
    * If required by local regulations, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
    E.4Principal exclusion criteria
    1.Previous administration of dasiglucagon (previously referred to as ZP4207).
    2. Known or suspected allergy to the trial drug or related products.
    3. Previous participation (randomization) in this trial.
    4. Circulatory instability requiring supportive medication or presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma.
    5. Requires exogenous insulin.
    6. Body weight of <4 kg (8.8 lbs).
    7. Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior to screening.
    8. Known or suspected presence of significant central nervous system disease/injury such that in the investigator’s opinion will affect trial participation.
    9. Use of systemic corticosteroids, e.g., hydrocortisone >20 mg/mg/m2 body surface area or equivalent in the 5 days before screening.
    10. Use of anti-inflammatory biological agents, or other immune-modulating agents in the 3 months prior to screening.
    11. 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).
    12. Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the patient’s ability to participate in the trial.
    13. 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.
    14. Any recognized clotting or bleeding disorders.
    15. Has participated in an interventional clinical trial (investigational or marketed product) within 3 months of screening or 5 half-lives of the drug under investigation (whichever comes first), or plans to participate in another clinical trial.
    16. The use of prescription or non-prescription medications known to cause QT prolongation.

    Randomization Exclusion Criteria:
    1. Use of glucagon within 24 hours before randomization.
    2. Significant changes to CHI medications during screening.
    3. An average of <3 events per week of hypoglycemia, as recorded in the diary during the 2 weeks prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment Period 1: Hypoglycaemia event rate, defined as average weekly number of hypoglycaemic events (PG <70 mg/dL or 3.9 mmol/L) during Weeks 2-4, as detected by self-monitored PG (SMPG).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 2-4
    E.5.2Secondary end point(s)
    Treatment Period 1
    - Increase in fasting tolerance (time from beginning of meal to the beginning of the first continuous 15-minute Continuous glucose monitoring [CGM] reading <70 mg/dL [3.9 mmol/L].
    - CGM percent time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Weeks 2-4.
    - Clinically significant hypoglycemia event rates, defined as average weekly number of events < 54 mg/dL (3.0 mmol/L) as detected by SMPG during Weeks 2-4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2-4
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Period 1: Randomised (Test drug versus SoC). Period 2: Open-label ( Test drug and SoC)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 years1
    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 years1
    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: 32
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    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 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
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 32
    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)
    Patients completing the trial will (pending investigator confirmation of continued positive benefit-risk balance) be offered to enter a long-term extension trial (Trial ZP4207-17106) to continue dasiglucagon treatment. Patients who do not continue in the long-term extension trial will have a Follow-up visit performed 4 weeks after stopping dasiglucagon treatment.
    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 Decision2018-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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