Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-04 @ 12:53 PM
Study NCT ID:
NCT03037359
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2017-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007074', 'term': 'Immunoglobulin G'}], 'ancestors': [{'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '24 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2017-01-20', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Hypotension', 'timeFrame': 'During infusion and up to 72 hours post infusion.', 'description': 'The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products.\n\nHypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.'}], 'secondaryOutcomes': [{'measure': 'Rate of Hepatic Impairment', 'timeFrame': 'Throughout the duration of study participation, up to approximately 140 days.', 'description': 'The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.'}, {'measure': 'Rate of Renal Impairment', 'timeFrame': 'Throughout the duration of study participation, up to approximately 140 days.', 'description': 'The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.'}, {'measure': 'Rates of Other Adverse Events', 'timeFrame': 'Throughout the duration of study participation, up to approximately 140 days.', 'description': 'The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PID'], 'conditions': ['Primary Immune Deficiency Disorder']}, 'descriptionModule': {'briefSummary': 'This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary immunodeficiency disease treated IGIV products.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with PID diagnosis\n* Current subjects requiring treatment with an IGIV\n\nExclusion Criteria:\n\n* Patients not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03037359', 'briefTitle': 'A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'ADMA Biologics, Inc.'}, 'officialTitle': 'A Multicenter, Non-interventional, Observational, Prospective Study to Assess Hypotension in Patients With Primary Immunodeficiency Disease Treated With Bivigam™ (Human 10%) or Other Commercial Human 10% Immune Globulin (Intravenous) (IGIV) Products During Infusion and up to 72 Hours Post Infusion', 'orgStudyIdInfo': {'id': '017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bivigam', 'description': 'Patients with primary immunodeficiency disease treated with Bivigam™', 'interventionNames': ['Biological: Bivigam']}, {'label': 'Other IGIV', 'description': 'Patients with primary immunodeficiency disease treated with other IGIVs', 'interventionNames': ['Biological: Other']}], 'interventions': [{'name': 'Bivigam', 'type': 'BIOLOGICAL', 'description': 'Human immune globulin', 'armGroupLabels': ['Bivigam']}, {'name': 'Other', 'type': 'BIOLOGICAL', 'description': 'Human immune globulin', 'armGroupLabels': ['Other IGIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93013', 'city': 'Carpinteria', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Specialty Pharmacy', 'geoPoint': {'lat': 34.39888, 'lon': -119.51846}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma of the Bay Area', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Immunoe Research Centers', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Central Georgia Infectious Disease Consultants', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Allergy and Sinus', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kanarek Adult & Pediatric Allergy & Immunology', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '67211', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Infectious Disease Consultants', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '11234', 'city': 'Syosset', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Allergy, Asthma & Immunology', 'geoPoint': {'lat': 40.82621, 'lon': -73.50207}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Allergy Asthma & Immunology Relief', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Clinical Research Associates', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '73131', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Institute of Allergy and Asthma Clinical Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Infectious Disease Consultants', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75225', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Discovery Clinical Trials', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Allergy Partners of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Allergy Immunology and Respiratory Care', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '22030', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Lysosomal Rare Disorders Research & Treatment Center', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADMA Biologics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}