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Completed

NCT Number: NCT02604485

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

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.

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Key information

Conditions

Congenital Hyperinsulinism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Infant, Newborn, Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cohort 1

Drug

XOMA 358 single dose level A administered by an intravenous infusion

Cohort 2

Drug

XOMA 358 single dose level B administered by an intravenous infusion

Cohort 3

Drug

XOMA 358 single dose level C administered by an intravenous infusion

Cohort 4

Drug

XOMA 358 single dose level D administered by an intravenous infusion

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: 42 days

    Safety assessed by treatment-emergent adverse events

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

    Time frame: 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

    Time frame: 42 days

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

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2015
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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