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

Congenital Hyperinsulinism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604485
• Other study ID #: X358602
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2015
• Last updated: February 2, 2017
• Start date: October 2015
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or ß 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.

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hyperinsulinism

Intervention

Drug:
• Cohort 1
XOMA 358 single dose level A administered by an intravenous infusion
• Cohort 2
XOMA 358 single dose level B administered by an intravenous infusion
• Cohort 3
XOMA 358 single dose level C administered by an intravenous infusion
• Cohort 4
XOMA 358 single dose level D administered by an intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	Safety assessed by treatment-emergent adverse events	42 days
Primary	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	42 days
Primary	Fasting and post prandial blood glucose levels	Assessment of blood glucose collected at time points specified in the protocol	42 days