An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
NCT ID: NCT02772718
Last Updated: 2021-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2016-04-30
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1 - single dose
Cohorts A, B, and C
XOMA 358 single dose level A
XOMA 358 single dose level A administered by intravenous infusion
XOMA 358 single dose level B
XOMA 358 single dose level B administered by an intravenous infusion
XOMA 358 single dose level C
XOMA 358 single dose level C administered by an intravenous infusion
Part 2 - multiple doses
Cohort 1
XOMA 358 multiple dose level 1
XOMA 358 multiple dose level 1 administered by an intravenous infusion
Interventions
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XOMA 358 single dose level A
XOMA 358 single dose level A administered by intravenous infusion
XOMA 358 single dose level B
XOMA 358 single dose level B administered by an intravenous infusion
XOMA 358 single dose level C
XOMA 358 single dose level C administered by an intravenous infusion
XOMA 358 multiple dose level 1
XOMA 358 multiple dose level 1 administered by an intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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XOMA (US) LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Allan Gordon, MD, PhD
Role: STUDY_DIRECTOR
XOMA (US) LLC
Locations
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Aurora, Colorado, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Countries
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Other Identifiers
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X358603
Identifier Type: -
Identifier Source: org_study_id
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