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    The EU Clinical Trials Register currently displays   35896   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-002847-32
    Sponsor's Protocol Code Number:X358602
    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:2015-08-24
    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 number2015-002847-32
    A.3Full title of the trial
    A Single-Dose Open-Label Study of XOMA 358 in Subjects with Congenital Hyperinsulinism (HI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single-dose study of a new biologic drug for people with abnormal levels of insulin due to a genetic dysfunction
    A.4.1Sponsor's protocol code numberX358602
    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 SponsorXOMA (US) LLC
    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 supportXOMA (US) LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Networks Services (UK) Ltd
    B.5.2Functional name of contact pointBioDesk
    B.5.3 Address:
    B.5.3.1Street AddressFountain Court, 2 Victoria Square, Victoria Street
    B.5.3.2Town/ citySt. Albans
    B.5.3.3Post codeAL1 3TF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441727884612
    B.5.6E-mailyadvinder.gill@clinical.net.au
    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 numberEMA/OD/040/16
    D.3 Description of the IMP
    D.3.1Product nameXOMA 358
    D.3.2Product code XOMA 358
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNimunoglobulin G 2 (IgG2)
    D.3.9.2Current sponsor codeXOMA 358
    D.3.9.3Other descriptive namefully human IgG2 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Hypoglycaemia associated with congenital hyperinsulinism
    E.1.1.1Medical condition in easily understood language
    Low glucose associated with abnormally high level of insulin due to a specific birth defect
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10020644
    E.1.2Term Hyperinsulinism NOS
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10022484
    E.1.2Term Insulin hypoglycaemia
    E.1.2System Organ Class 100000004861
    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 safety and clinical pharmacology of a single dose of XOMA 358 in subjects with hypoglycaemia associated with congenital hyperinsulinism.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent and, as applicable, assent, before any study-specific procedures are performed
    2. Aged at least 12 years at Screening
    3. An established clinical diagnosis, with or without a genetic diagnosis, of congenital hyperinsulinism
    4. Duration of glucose levels < 70 mg/dL, by CGM, for an average of at least
    120 minutes across baseline Days -3, -2, and -1 with no single duration < 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment
    5. In the opinion of the Investigator, can be safely washed out of background HI medications
    6. Hepatic ultrasound at Screening without clinically significant findings or evidence of peliosis hepatis
    7. For female subjects of childbearing potential, a negative serum pregnancy test
    8. For females subjects of childbearing potential and male subjects with a female partner of childbearing potential, a willingness to use contraceptive measures adequate to prevent the subject or subject’s partner from becoming pregnant during the study and for at least 4 months after the administration of study drug.
    E.4Principal exclusion criteria
    1. Any out-of-range laboratory value at Screening that has not been reviewed, approved, and documented as not clinically significant by the Investigator, with the exception of liver function tests for total bilirubin, ALT, AST, and ALP, which must be within 1.5X the upper limit of normal (UNL) for the reference range
    2. During confinement, use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists, that may affect glucose metabolism. Such agents will be washed out after checking-in to the in-patient research facility and before dosing. Topical, inhaled, and intranasal corticosteroids at doses that are unlikely to affect glucose homeostasis and corticosteroids for ophthalmic use are permitted.
    3. Body Mass Index ≥ 35 kg/m2
    4. History of malignancy within 3 years before Screening other than carcinoma in situ of the cervix or adequately treated nonmetastatic squamous or basal cell carcinoma of the skin
    5. History of seropositivity for HIV antibody, hepatitis B, or hepatitis C antibody
    6. Major general surgery within 3 months before Screening or anticipated during the study period
    7. Known allergy or sensitivity to XOMA 358 or any component of the study drug
    8. Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug before Day 1, whichever is longer. Participation in registries and purely diagnostic studies is allowed.
    9. Female subjects who are pregnant, planning to become pregnant during the course of the study, have recently delivered (within 3 months before Screening), or are breast- feeding
    10. Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug
    11. Any organ condition, concomitant disease (eg, psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study (eg, may affect absorption, distribution, metabolism, or elimination of the study drug) or that, in the opinion of the Investigator and/or Sponsor’s medical monitor, would pose an unacceptable risk to the subject in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Effect on Glucose (Glucose AUC24, average time per day of blood glucose < 70 mg/dL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured at various time points (see schedule of events)
    E.5.2Secondary end point(s)
    Number of hypoglycemic events per day with glucose < 70 mg/dL, <60 mg/dL, and <50 mg/dL
    Fasting and postprandial glucose, insulin, C-peptide, ketones, free fatty acids;
    Time to hypoglycaemia;
    Frequency of hypoglycemia events (<60 mg/dL)
    Concomitant treatment/medications used during rescue
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured at various time points (see schedule of events)
    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 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) 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) 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 trial4
    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 No
    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
    United States
    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
    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 months6
    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 months6
    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: 5
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 16
    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)
    The single dose treatment in this study will inform the dosing regimen for next studies and patients will have the option to participate in any future studies.
    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 Decision2015-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-13
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