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    Summary
    EudraCT Number:2017-004546-15
    Sponsor's Protocol Code Number:ZP4207-17106
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-09-10
    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 number2017-004546-15
    A.3Full title of the trial
    An Extension Trial Evaluating the Long-term Safety and Efficacy 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 Trial to evaluate the Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    A.4.1Sponsor's protocol code numberZP4207-17106
    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/ citySoborg (Copenhagen)
    B.5.3.3Post code2860
    B.5.3.4CountryDenmark
    B.5.4Telephone number4588 77 36 00
    B.5.5Fax number458877 3898
    B.5.6E-mailcschioler@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
    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 long-term safety of dasiglucagon administered as SC infusion in children with CHI.
    E.2.2Secondary objectives of the trial
    -To evaluate the long-term efficacy of dasiglucagon in reducing hypoglycemia
    -To evaluate the long-term efficacy of dasiglucagon in reducing glucose requirements
    -To evaluate the long-term tolerability of dasiglucagon administered as SC infusion in children with CHI
    -To investigate quality of life (QoL) and resource utilization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completed treatment in either Trial ZP4207-17103 or ZP4207-17109
    2. Expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of AEs experienced in the lead-in trial), with signed investigator statement documenting the positive benefit-risk assessment made
    3. Has a negative serum pregnancy test at baseline (only for females of child-bearing potential)
    4. Sexually active female patients and their partners must use acceptable contraception or refrain from sexual activity from baseline 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
    Germany: Only highly effective methods of birth control are accepted (i.e., one that results in less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence.
    5. Able and willing to comply with trial procedures
    6. Following receipt of oral and written information about the trial, the patient (depending on local institutional review board [IRB]/independent ethics committee [IEC] requirements) must provide assent and one or both parents* or guardian of the patient must provide signed informed consent before any trial-related activity is carried out.
    France, Germany, Israel: The consent must correspond to the patient’s presumed will where such a will can be ascertained.
    * 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. The patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator’s opinion.
    2. Has participated in an interventional clinical trial (investigational or marketed product) within 3 months before baseline or 5 half-lives of the drug under investigation (whichever comes first) or plans to participate in another clinical trial. Excluded from this is participation in Trial ZP4207-17103, Trial ZP4207-17109, and/or 18F-Dopa positron emission tomography computed tomography/magnetic resonance imaging investigation (when performed as a part of a clinical trial) for diagnosis of focal CHI.
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to Month 1, Month 1 to Month 3 and then each 3 month period for the first year;
    E.5.2Secondary end point(s)
    -Total amount of gastric carbohydrates administered (nasogastric [NG] tube or gastrostomy) to treat hypoglycemia
    -Time to removal of NG tube or gastrostomy
    -Time to pancreatic surgery (sub-total or total pancreatectomy)
    -Continuous glucose monitoring (CGM) percent time < 70 mg/dL (3.9 mmol/L)
    -Rate of CGM-detected hypoglycemia episodes <70 mg/dL (3.9
    mmol/L) for 15 minutes or more
    -Rate of clinically significant CGM-detected hypoglycemia episodes
    <54 mg/dL (3.0 mmol/L) for 15 minutes or more
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 1, Month 1 to Month 3 and then each 3 month period between visits.
    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 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 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 EEA2
    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
    Israel
    United Kingdom
    United States
    Germany
    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 Visit of the last patient, defined as the time all patients have reached Trial Completion (completed the Follow-up Period, or the EoT (End of the Treatment) Visit if continuing treatment with dasiglucagon commercially or through an EAP (Early Access program) whichever occurs first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 44
    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: 35
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    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 30
    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)
    None.
    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 Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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