Hypoglycemia associated with congenital hyperinsulinism MedDRA version: 19.0 Level: LLT Classification code 10077227 Term: Hyperinsulinemic hypoglycemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 19.0 Level: LLT Classification code 10020644 Term: Hyperinsulinism NOS System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 19.0 Level: PT Classification code 10061211 Term: Hyperinsulinism System Organ Class: 10027433 - Metabolism a
Conditions
Interventions
Product Code: XOMA 358
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: XOMA 358
Current Sponsor code: XOMA 358
Other descriptive name: fully human IgG2 monoclonal antibody
Concentrati
Sponsors
XOMA (US) LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent and, as applicable, assent, before any study specific procedures are performed 2. Aged 12 to 65 years at Screening 3. Body mass index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, except for the following liver function test exclusions: - total bilirubin = 1.5X upper limit of normal - ALT, AST, or ALP = 2X upper limit of normal 2. Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or ß agonists, that may affect glucose metabolism. Such agents will be washed out before dosing. Topical, inhaled, and intranasal corticosteroids at doses that are unlikely to affect glucose homeostasis and corticosteroids for ophthalmic use are permitted. 3. Use of any long-acting somatostatin analogs or glucose-affecting medications that require > 72 hour washout Note: Patients who are on a stable dose and regimen of a long-acting somatostatin analog and meet inclusion criterion number 5 for hypoglycemia during Screening may remain on such treatment and be enrolled into the study upon discussion and agreement between the Investigator and the XOMA Medical Monitor. 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 patients 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 patients 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 patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia associated with congenital hyperinsulinism (HI).;Secondary Objective: Not applicable;Primary end point(s): Biological (analyses for each dose): • Glucose AUC24 • Cumulative time blood glucose < 70 mg/dL (< 3.89 mM) • Fasting and postprandial glucose, insulin, c-peptide • Time to hypoglycemia during provocation (< 60 mg/dL [< 3.33 mM]) • Frequency of hypoglycemic events (< 60 mg/dL [< 3.33 mM]) • Concomitant treatment/medications used during rescue Additional analyses will be performed, as appropriate. Safety: Safety will be assessed through an examination of the incidence, severity, and type of treatment-emergent adverse events and changes in vital signs, physical examination results, laboratory test results, ECG, hepatic ultrasound, glucose monitoring via a bedside glucometer, infusion site reaction, and use of concomitant medications and concomitant treatment from baseline to specified time points throughout the trial.;Timepoint(s) of evaluation of this end point: Measured at various time points (see schedule of events) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany
Contacts
Public ContactKlinische Forschung
KF2 / Kornelia Fiering Klinische Forschung
Outcome results
None listed