Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02604485
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : October 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604485


Locations
Layout table for location information
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United Kingdom
London, United Kingdom
Sponsors and Collaborators
XOMA (US) LLC
Investigators
Layout table for investigator information
Study Director: Allan Gordon, MD, PhD XOMA (US) LLC

Layout table for additonal information
Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT02604485     History of Changes
Other Study ID Numbers: X358602
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Keywords provided by XOMA (US) LLC:
Hypoglycemia
Congenital Hyperinsulinism
Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Hyperinsulinism
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia