Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-06 @ 10:32 PM
Study NCT ID:
NCT03164967
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-28', 'releaseDate': '2024-02-02'}, {'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2024-02-02'}}, '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temporally Associated Adverse Events', 'timeFrame': 'During each infusion (During or within 1 hour, 24 hours and 72 hours of completion of an infusion)', 'description': 'Incidence of adverse events (During or within 1 hour, 24 hours and 72 hours of completion of an infusion)'}, {'measure': 'Number of Temporally Associated Adverse Events', 'timeFrame': 'Up to 72 hours of completion of an infusion', 'description': 'Mean number of temporally associated per infusion'}, {'measure': 'Serious Adverse Events', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of serious adverse events'}, {'measure': 'Related Serious Adverse Events', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of related serious adverse events'}, {'measure': 'Treatment Emergent Adverse Events', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of treatment emergent adverse events'}, {'measure': 'Related Treatment Emergent Averse Events', 'timeFrame': 'Within 72 hours of infusion', 'description': 'Incidence of adverse events that first appear, or that worsen relative to the pre-treatment state, which occur during and within 72 hours of treatment administration'}, {'measure': 'Non-treatment Emergent Adverse Events', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of adverse events which do not have a causal relationship with study treatment'}, {'measure': 'Temporally Associated Infusion Adverse Events', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of adverse events which have a causal relationship with infusion treatment'}, {'measure': 'Adverse Reactions', 'timeFrame': 'Up to approximately 7 months', 'description': 'Number and incidence of adverse reactions plus suspected adverse reactions combined'}, {'measure': 'Related Adverse Reactions', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of adverse infusion related reactions'}, {'measure': 'Infusion Site Reactions', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence reactions occuring at the infusion site'}, {'measure': 'Vital Signs', 'timeFrame': 'Before and after each administration of study drug through study completion, up to approximately 7 months', 'description': 'Change in vital signs'}, {'measure': 'Temporally Associated Adverse Events Following Infusions', 'timeFrame': 'Up to 72 hours after each infusion through study completion, up tp approximately 7 months', 'description': 'Incidence of adverse events'}], 'secondaryOutcomes': [{'measure': 'Total IgG Trough', 'timeFrame': 'At each visit through study completion, up tp approximately 7 months', 'description': 'Levels taken before any infusion'}, {'measure': 'IgG subclasses', 'timeFrame': 'Prior to first and last infusion, up tp approximately 7 months', 'description': 'Levels of subclasses 1- 4 before infusion'}, {'measure': 'Total IgG Post', 'timeFrame': 'At each infusion through study completion, up tp approximately 7 months', 'description': 'End of infusion level of Total IgG'}, {'measure': 'Cmax', 'timeFrame': 'At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months', 'description': 'Pharmacokinetic measure at 5th or 7th infusion'}, {'measure': 'Tmax', 'timeFrame': 'At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months', 'description': 'Pharmacokinetic measure at 5th or 7th infusion'}, {'measure': 'AUC(0-ʈ)', 'timeFrame': 'At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months', 'description': 'Pharmacokinetic measure at 5th or 7th infusion'}, {'measure': 'AUC(0-∞)', 'timeFrame': 'At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after infusion', 'description': 'Pharmacokinetic measure at 5th or 7th infusion'}, {'measure': 'Terminal phase elimination half-life (ʈ½)', 'timeFrame': 'At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months', 'description': 'Pharmacokinetic measure at 5th or 7th infusion'}, {'measure': 'Antibodies', 'timeFrame': 'At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months', 'description': 'Levels of specific antibodies (antipneumococcal capsular polysaccharide, antihaemophilus influenza B'}, {'measure': 'Infections', 'timeFrame': 'Up to approximately 7 months', 'description': 'Number of infections of any kind, serious and non-serious'}, {'measure': 'First Serious Bacterial Infection', 'timeFrame': 'Up to approximately 7 months', 'description': 'Time to first Serious Bacterial Infections in days'}, {'measure': 'Serious Bacterial Infections', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of Serious Bacterial Infections'}, {'measure': 'Other Infections', 'timeFrame': 'Up to approximately 7 months', 'description': 'Incidence of infections other than Serious Bacterial Infections'}, {'measure': 'Resolution of Infections', 'timeFrame': 'Up to approximately 7 months', 'description': 'Time to resolution of Infections in days'}, {'measure': 'Fever', 'timeFrame': 'Up to approximately 7 months', 'description': 'Episodes of Fever'}, {'measure': 'Missed Days', 'timeFrame': 'Up to approximately 7 months', 'description': 'Number of days missed of school or work due to infections and treatment'}, {'measure': 'Hospitalizations', 'timeFrame': 'Up to approximately 7 months', 'description': 'Number of hospitalizations due to infections'}, {'measure': 'Terminal phase elimination rate (λZ)', 'timeFrame': 'At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months', 'description': 'Pharmacokinetic measure at 5th or 7th infusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Humoral Immune Response']}, 'descriptionModule': {'briefSummary': 'This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in subjects aged 2-16 with primary immune deficiency disorders associated with defects in humoral immunity to generate additional data on these populations, and more specifically safety and pharmacokinetic (PK) assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent/Assent\n* Male or female between 2 and 16 years, inclusive, at time of Signing Informed Consent/Assent\n* Have a confirmed and documented clinical diagnosis of Primary Immune Deficiency Disorder, including hypogammaglobulinemia or agammaglobulinemia.\n* Have received IGIV therapy which was maintained at a steady dose (± 25% of the mean dose) for at least 3 months prior to study entry, and have maintained a trough IgG level at least 500mg/dL prior to receiving BIVIGAM®.\n* Subjects and/or parents/legal guardians must be able to understand and adhere to the study visit schedule and all other protocol requirements.\n\nExclusion Criteria:\n\n* Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction).\n* Known intolerance to proteins of human origin or known allergic reactions to components of the study product(s).\n* Any previous randomization/participation in this clinical study must be discussed with and approved by the medical director (or designee).\n* Inability or lacking motivation to participate in the study.\n* Medical condition, laboratory finding, or physical exam finding (specify, e.g., vital signs outside of specific range that precludes participation. Per lab results at the Screening visit through Baseline.\n* Confirmed Screening visit laboratory results ˃2.5 X ULN as defined for pediatric populations for any of the following: ALT (alanine aminotransferase/SGPT), AST (aspartate aminotransferase/SGOT), LDH (lactate dehydrogenase), BUN (blood urea nitrogen), Serum creatinine\n* Has selective IgA deficiency or demonstrated antibodies to IgA.\n* History of thrombotic complications of IGIV therapy or history of (deep vein thrombosis)DVT.\n* Current use of daily corticosteroids (\\>10 mg of prednisone equivalent/day),immunosuppressants or immunomodulators are not allowed unless approved in advance by the medical monitor. Intermittent use of corticosteroids during the study is allowed if medically necessary.\n* Positive diagnosis of hepatitis B or hepatitis C.\n* Positive human immunodeficiency virus (HIV) test.\n* Subject has had a serious bacterial infection (SBI) within the last 3 months.\n* Subject has an active infection and is receiving antibiotic therapy for the treatment of this infection at the time of Screening. Note: if the subject is deemed a Screen Failure due to a nonserious active infection requiring antibiotic therapy, the subject may be rescreened 3 or 4 weeks (depending on drug administration schedule) after the initial screening.\n* Subject has a history of thrombotic events (including deep vein thrombosis, myocardial infarction, cerebrovascular accident and pulmonary embolism) within 6 months before 1st IGIV dose or has preexisting risk factors for thrombotic events.\n* Acquired medical condition known to cause secondary immune deficiency such as chronic lymphacitic leukemia, lymphoma or multiple lymphoma.\n* Subjects with protein-losing enteropathies, hypoalbuminaemia.\n* Females taking oral contraceptives.\n* Pregnancy or unreliable contraceptive measures or lactation period (females of childbearing potential (female capable of becoming pregnant) only. Males capable of reproduction must agree to a double barrier method of contraception during their study participation.'}, 'identificationModule': {'nctId': 'NCT03164967', 'briefTitle': 'Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16', 'organization': {'class': 'INDUSTRY', 'fullName': 'ADMA Biologics, Inc.'}, 'officialTitle': 'A Phase IV, Multicenter, Open-label Study to Evaluate the Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Disorders in Subjects Aged 2 to 16', 'orgStudyIdInfo': {'id': '994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active Drug', 'description': 'All subjects will receive Bivigam based on their prior dosing to be adjusted as clinically necessary.', 'interventionNames': ['Biological: Bivigam']}], 'interventions': [{'name': 'Bivigam', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Active Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'IMMUNOe Research Centers', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '27710', 'city': 'Durham', 'state': 'Florida', 'country': 'United States', 'facility': 'Duke University Medical Center'}, {'zip': '33408', 'city': 'North Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Allergy Associates of the Palm Beaches', 'geoPoint': {'lat': 26.81756, 'lon': -80.08199}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Health, Pediatric Allergy, Immunology & Rheumatology', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'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': '75225', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Discovery Clinical Trials', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'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': 'UNDECIDED', 'description': 'Not yet determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADMA Biologics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-02', 'type': 'RELEASE'}, {'date': '2024-02-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'ADMA Biologics, Inc.'}}}}