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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: XOMA (US) LLC

Current Primary Outcome:

• Incidence of treatment-emergent adverse events [ Time Frame: 42 days ]
  Safety assessed by treatment-emergent adverse events
• 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
• Fasting and post prandial blood glucose levels [ Time Frame: 42 days ]
  Assessment of blood glucose collected at time points specified in the protocol

Original Primary Outcome:

• Safety assessed by treatment-emergent adverse events [ Time Frame: 42 days ]
  Safety assessed by treatment-emergent adverse events
• Safety assessed by pre- and post-treatment serial measurements of vital signs and laboratory test results [ Time Frame: 42 days ]
  Safety assessed by pre- and post-treatment serial measurements of vital signs and laboratory test results
• Assessment of blood glucose collected at time points specified in the protocol [ Time Frame: 42 days ]
  Assessment of blood glucose collected at time points specified in the protocol

Current Secondary Outcome:

Original Secondary Outcome:

Information By: XOMA (US) LLC

Dates:
Date Received: October 26, 2015
Date Started: October 2015
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017