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

• Sponsor: XOMA (US) LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02604485
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Arm: 1
• Duration (Months): 15
• Patients Per Site: 5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Hyperinsulinism	Drug: Cohort 1; Drug: Cohort 2; Drug: Cohort 3; Drug: Cohort 4	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism (HI)
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Cohort XOMA 358 dose level A, dose level B, dose level C, and dose level D.	Drug: Cohort 1; XOMA 358 single dose level A administered by an intravenous infusion; Drug: Cohort 2; XOMA 358 single dose level B administered by an intravenous infusion; Drug: Cohort 3; XOMA 358 single dose level C administered by an intravenous infusion; Drug: Cohort 4; XOMA 358 single dose level D administered by an intravenous infusion

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events [42 days]

   Safety assessed by treatment-emergent adverse events

2. Change from baseline in glucose levels as measured using a continuous glucose monitor [42 days]

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

3. Fasting and post prandial blood glucose levels [42 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Philadelphia	Pennsylvania	United States
2		London		United Kingdom

Sponsors and Collaborators

• XOMA (US) LLC

Investigators

• Study Director: Allan Gordon, MD, PhD, XOMA (US) LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: XOMA (US) LLC
• ClinicalTrials.gov Identifier: NCT02604485
• Other Study ID Numbers: X358602
• First Posted: Nov 13, 2015
• Last Update Posted: Feb 6, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by XOMA (US) LLC: Hypoglycemia; Congenital Hyperinsulinism
• Additional relevant MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hyperinsulinism

Study Results

No Results Posted as of Feb 6, 2017