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CompletedNCT02604485Updated Feb 6, 2017

A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism

A Phase 2 interventional study of Cohort 1 and Cohort 2 in Congenital Hyperinsulinism, sponsored by XOMA (US) LLC. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-06.

Sponsored by XOMA (US) LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.

02

Conditions studied

  • Congenital Hyperinsulinism

Keywords

  • Hypoglycemia
  • Congenital Hyperinsulinism
03

In context

Congenital Hyperinsulinism

46 studies on the registry are indexed under Congenital Hyperinsulinism; 7 are open to participants now.

This study's enrollment of 10 is below the median of 23 across 35 interventional studies indexed under Congenital Hyperinsulinism.

Browse Congenital Hyperinsulinism studies →

Lead sponsor

XOMA (US) LLC is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of congenital hyperinsulinism
  • Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment.
  • Can safely washout of background medications used to treat hyperinsulinism.

Exclusion criteria

Exclusion Criteria:

  • Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism
  • Body Mass Index ≥ 35 kg/m2
  • Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    Cohort

    XOMA 358 dose level A, dose level B, dose level C, and dose level D.

    Drug: Cohort 1 · Drug: Cohort 2 · Drug: Cohort 3 · Drug: Cohort 4

Interventions

  • DrugCohort 1

    XOMA 358 single dose level A administered by an intravenous infusion

  • DrugCohort 2

    XOMA 358 single dose level B administered by an intravenous infusion

  • DrugCohort 3

    XOMA 358 single dose level C administered by an intravenous infusion

  • DrugCohort 4

    XOMA 358 single dose level D administered by an intravenous infusion

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Safety assessed by treatment-emergent adverse events

    Time frame: 42 days

  2. Change from baseline in glucose levels as measured using a continuous glucose monitor

    Safety assessed by pre- and post-treatment measurements of vital signs and laboratory test results

    Time frame: 42 days

  3. Fasting and post prandial blood glucose levels

    Assessment of blood glucose collected at time points specified in the protocol

    Time frame: 42 days

07

Study locations

2 sites
  • Philadelphia, Pennsylvania, United States
  • London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02604485
Lead sponsor
XOMA (US) LLC
Responsible party
Sponsor
First posted
Nov 13, 2015
Start date
Oct 2015
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Feb 6, 2017

Study contacts

Allan Gordon, MD, PhD
study director · XOMA (US) LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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