Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-17 @ 4:45 AM
Study NCT ID:
NCT02772718
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622674', 'term': 'XOMA 358'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -', 'timeFrame': '42 days', 'description': 'Safety assessed by treatment-emergent adverse events'}, {'measure': 'Single dose Part 1 - Change from baseline in glucose levels', 'timeFrame': 'Baseline and 22 days', 'description': 'Glucose measured using a continuous glucose monitor'}, {'measure': 'Single dose Part 1 - Blood glucose levels', 'timeFrame': 'Daily through Day 11 and at Day 22', 'description': 'Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol'}, {'measure': 'Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol', 'timeFrame': '28 days', 'description': 'Glucose measured by continuous glucose monitoring every 5 min'}, {'measure': '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', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypoglycemia'], 'conditions': ['Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged at least 18 years of age\n* 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.\n* Received gastric bypass surgery more than 1 year before dosing\n* 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.\n\nExclusion Criteria:\n\n* History of type 1 diabetes\n* Planned use of the following medications on or after Day -3 (Part 1):\n\n * Any agent for hypoglycemia, such as diazoxide or octreotide\n * Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas, SGLT2 inhibitors, and GLP-1 agonists\n * Systemic glucocorticoids or β agonists that may affect glucose metabolism\n * Long-acting somatostatin analogs or glucose-affecting medications\n* During Part 2, the following therapies are prohibited as specified below:\n\n * 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.\n * Acetaminophen-containing products during periods of continuous glucose monitoring.\n\nMedications 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.\n\n* Major general surgery within 3 months before study entry or anticipated during the study period\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02772718', 'acronym': 'XOMA 358', 'briefTitle': 'An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'XOMA (US) LLC'}, 'officialTitle': 'An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': 'X358603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - single dose', 'description': 'Cohorts A, B, and C', 'interventionNames': ['Drug: XOMA 358 single dose level A', 'Drug: XOMA 358 single dose level B', 'Drug: XOMA 358 single dose level C']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - multiple doses', 'description': 'Cohort 1', 'interventionNames': ['Drug: XOMA 358 multiple dose level 1']}], 'interventions': [{'name': 'XOMA 358 single dose level A', 'type': 'DRUG', 'description': 'XOMA 358 single dose level A administered by intravenous infusion', 'armGroupLabels': ['Part 1 - single dose']}, {'name': 'XOMA 358 single dose level B', 'type': 'DRUG', 'description': 'XOMA 358 single dose level B administered by an intravenous infusion', 'armGroupLabels': ['Part 1 - single dose']}, {'name': 'XOMA 358 single dose level C', 'type': 'DRUG', 'description': 'XOMA 358 single dose level C administered by an intravenous infusion', 'armGroupLabels': ['Part 1 - single dose']}, {'name': 'XOMA 358 multiple dose level 1', 'type': 'DRUG', 'description': 'XOMA 358 multiple dose level 1 administered by an intravenous infusion', 'armGroupLabels': ['Part 2 - multiple doses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Allan Gordon, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'XOMA (US) LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XOMA (US) LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}