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An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery (XOMA 358)

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: NCT02772718
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.

Condition or disease Intervention/treatment Phase
Hypoglycemia Drug: XOMA 358 single dose level A Drug: XOMA 358 single dose level B Drug: XOMA 358 single dose level C Drug: XOMA 358 multiple dose level 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Study Start Date : April 2016
Actual Primary Completion Date : May 2021
Actual Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 - single dose
Cohorts A, B, and C
 Drug: XOMA 358 single dose level A
XOMA 358 single dose level A administered by intravenous infusion

Drug: XOMA 358 single dose level B
XOMA 358 single dose level B administered by an intravenous infusion

Drug: XOMA 358 single dose level C
XOMA 358 single dose level C administered by an intravenous infusion
Experimental: Part 2 - multiple doses
Cohort 1
 Drug: XOMA 358 multiple dose level 1
XOMA 358 multiple dose level 1 administered by an intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events - [ Time Frame: 42 days ]
    Safety assessed by treatment-emergent adverse events

  2. Single dose Part 1 - Change from baseline in glucose levels [ Time Frame: Baseline and 22 days ]
    Glucose measured using a continuous glucose monitor

  3. Single dose Part 1 - Blood glucose levels [ Time Frame: Daily through Day 11 and at Day 22 ]
    Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol

  4. Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol [ Time Frame: 28 days ]
    Glucose measured by continuous glucose monitoring every 5 min

  5. Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged at least 18 years of age
  • Body Mass Index < 35 kg/m2 at baseline, unless discussed with Medical Monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug.
  • Received gastric bypass surgery more than 1 year before dosing
  • Occurrence of postprandial hypoglycemia (blood glucose less than 60mg/dL) during the Baseline provocation assessments and/or by continuous glucose monitoring, as defined in the protocol.

Exclusion Criteria:

  • History of type 1 diabetes

  • Planned use of the following medications on or after Day -3 (Part 1):

    • Any agent for hypoglycemia, such as diazoxide or octreotide
    • Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas, SGLT2 inhibitors, and GLP-1 agonists
    • Systemic glucocorticoids or β agonists that may affect glucose metabolism
    • Long-acting somatostatin analogs or glucose-affecting medications

  • During Part 2, the following therapies are prohibited as specified below:

    • Tramadol and any other medications not used in the treatment of post-bariatric surgery hypoglycemia that may cause hypoglycemia or fluctuations in blood glucose levels.
    • Acetaminophen-containing products during periods of continuous glucose monitoring.

Medications such as tramadol may cause hypoglycemia or fluctuations in blood glucose levels and, as such, use of such medications is subject to the restrictions as described above during the study. Acetaminophen can interfere with the accuracy of the glucose sensor of the continuous glucose monitoring system and is, therefore, prohibited during continuous glucose monitoring.

  • Major general surgery within 3 months before study entry or anticipated during the study period

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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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): NCT02772718


Locations
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United States, Colorado
Aurora, Colorado, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Rochester, Minnesota, United States
Sponsors and Collaborators
XOMA (US) LLC
Investigators
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Study Director: Allan Gordon, MD, PhD XOMA (US) LLC
More Information
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Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT02772718    
Other Study ID Numbers: X358603
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Keywords provided by XOMA (US) LLC:
Hypoglycemia
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
 Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs