Back to resultsA Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
Primary Purpose
Congenital Hyperinsulinism
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Hyperinsulinism focused on measuring Hypoglycemia, Congenital Hyperinsulinism
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cohort
Arm Description
XOMA 358 dose level A, dose level B, dose level C, and dose level D.
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events
Safety assessed by treatment-emergent adverse events
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
Fasting and post prandial blood glucose levels
Assessment of blood glucose collected at time points specified in the protocol
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02604485
Brief Title
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
Official Title
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism (HI)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hyperinsulinism
Keywords
Hypoglycemia, Congenital Hyperinsulinism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort
Arm Type
Other
Arm Description
XOMA 358 dose level A, dose level B, dose level C, and dose level D.
Intervention Type
Drug
Intervention Name(s)
Cohort 1
Intervention Description
XOMA 358 single dose level A administered by an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Cohort 2
Intervention Description
XOMA 358 single dose level B administered by an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Cohort 3
Intervention Description
XOMA 358 single dose level C administered by an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Cohort 4
Intervention Description
XOMA 358 single dose level D administered by an intravenous infusion
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
Safety assessed by treatment-emergent adverse events
Time Frame
42 days
Title
Change from baseline in glucose levels as measured using a continuous glucose monitor
Description
Safety assessed by pre- and post-treatment measurements of vital signs and laboratory test results
Time Frame
42 days
Title
Fasting and post prandial blood glucose levels
Description
Assessment of blood glucose collected at time points specified in the protocol
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Gordon, MD, PhD
Organizational Affiliation
XOMA (US) LLC
Official's Role
Study Director
Facility Information:
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
We'll reach out to this number within 24 hrs