Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-20 @ 12:50 AM
Study NCT ID:
NCT00220766
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D000361', 'term': 'Agammaglobulinemia'}, {'id': 'D016511', 'term': 'Severe Combined Immunodeficiency'}, {'id': 'D014923', 'term': 'Wiskott-Aldrich Syndrome'}, {'id': 'D017074', 'term': 'Common Variable Immunodeficiency'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D008231', 'term': 'Lymphopenia'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005719', 'term': 'gamma-Globulins'}, {'id': 'D002210', 'term': 'Caprylates'}, {'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'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'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-24', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infusion related adverse events', 'timeFrame': 'within 72 hours after infusion'}], 'secondaryOutcomes': [{'measure': 'All adverse events', 'timeFrame': 'within 72 hours after infusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary Immune Deficiency', 'IGIV', 'Immunoglobulin G'], 'conditions': ['Immunologic Deficiency Syndrome', 'Agammaglobulinemia', 'Severe Combined Immunodeficiency', 'Wiskott-Aldrich Syndrome', 'Common Variable Immunodeficiency']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.', 'detailedDescription': 'This is a prospective, single blind, randomized, multi-center cross-over trial in patients with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune Deficiency will be treated with two daily infusions given 3-4 weeks apart at the fixed individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any subject with an established dose in the range of 200-399 mg/kg will be assigned to receive 400 mg/kg during the course of the study during the same dosing schedule established prior to entry into the study.\n\nAfter a screening period lasting not more than four weeks, patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C, 10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min, whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema below.\n\nGroup 1:\n\n* Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)\n* Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)\n\nGroup 2:\n\n* Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)\n* Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial\n* Signed an informed consent written informed consent prior to initiation of any study related procedures\n* Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg\n\nExclusion Criteria:\n\n* History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products\n* Documented history of selective IgA deficiency (serum level \\<5.0 mg/dL) and known antibodies to IgA\n* Isolated IgG subclass deficiency with a normal total serum IgG level\n* Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction.\n* Pretreatment with anti-pyretics or anti-histamines\n* Congestive heart failure (New York Heart Association stage greater than Class II)\n* Renal insufficiency (creatinine \\>2.5 mg/dL)\n* Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)\n* Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse events (AEs)\n* Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain adequate trough levels\n* Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT00220766', 'briefTitle': 'Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grifols Therapeutics LLC'}, 'officialTitle': 'IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients', 'orgStudyIdInfo': {'id': '100348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)', 'interventionNames': ['Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified', 'Drug: Dextrose, 5% in Water']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)', 'interventionNames': ['Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified', 'Drug: Dextrose, 5% in Water']}], 'interventions': [{'name': 'Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified', 'type': 'DRUG', 'otherNames': ['Gamunex', 'IGIVnex', 'Gaminex', 'IGIV-C', 'Immune Globulin Intravenous (Human) , 10%', 'IGIV', 'BAY 41-1000', 'TAL-05-00004'], 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Dextrose, 5% in Water', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Departments of Medicine and Microbiology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Medical and Researach Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'International Center for Interdisciplinary Studies of Immunology', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'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': 'University of South Florida College of Medicine', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "The Clinical Trials Center, Children's Hospital", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Allergy, Asthma, and Immunology', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Optimed Research, LLC', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': 'T2N 2T8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': '3031 Hospital Drive Northwest', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6H 3K2', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M4V 1R2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Saint Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Erwin Gelfand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Medical and Research Center, Denver, CO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grifols Therapeutics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs', 'oldOrganization': 'Talecris Biotherapeutics, Inc.'}}}}