NCT02604485

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

October 26, 2015

Last Update Submit

February 2, 2017

Conditions

Congenital Hyperinsulinism

Keywords

HypoglycemiaCongenital Hyperinsulinism

Outcome Measures

Primary Outcomes (3)

  • Incidence of treatment-emergent adverse events

    Safety assessed by treatment-emergent adverse events

    42 days

  • 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

  • Fasting and post prandial blood glucose levels

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

    42 days

Study Arms (1)

Cohort

OTHER

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

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

Interventions

Cohort 1DRUG

XOMA 358 single dose level A administered by an intravenous infusion

Cohort
Cohort 2DRUG

XOMA 358 single dose level B administered by an intravenous infusion

Cohort
Cohort 3DRUG

XOMA 358 single dose level C administered by an intravenous infusion

Cohort
Cohort 4DRUG

XOMA 358 single dose level D administered by an intravenous infusion

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Congenital HyperinsulinismHypoglycemia

Interventions

KPNA1 protein, human

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Allan Gordon, MD, PhD

    XOMA (US) LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2015

First Posted

November 13, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 6, 2017

Record last verified: 2017-02

Locations

US(1)GB(1)