Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 4:27 AM
Study NCT ID:
NCT00782106
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2008-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously
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': 'D005719', 'term': 'gamma-Globulins'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2007-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2008-10-29', 'studyFirstSubmitQcDate': '2008-10-29', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to administer, after priming with recombinant human hyaluronidase, at least one half of a 4-week dose (minimum of 200 mg/kg) of IgG in a single infusion site, via the subcutaneous route, with no more than mild local adverse drug reactions.', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Immunodeficiency Diseases (PID)']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent from either the subject or the subject's legally acceptable representative\n* Diagnosis of a PID disorder as defined by World Health Organization criteria1 for which the subject had been receiving a regimen of weekly or biweekly (every-other-week) subcutaneous IgG infusions or IGIV infusions every 21 to 28 days over a period of at least 8 weeks pre-study at an equivalent of a 4-week dose of 300 to 800 mg/kg bodyweight\n* Adults/adolescents aged 16 years and older)\n* For female subjects of child-bearing age: negative urine pregnancy test result at study entry and agreement to employ adequate birth control measures for the duration of the study\n\nExclusion Criteria:\n\n* Subjects positive at enrollment for one or more of the following: HBsAg, PCR for HCV, PCR for HIV Type 1\n* Subjects with levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5 times the upper limit of normal for the testing laboratory\n* Subjects with neutropenia (defined as an absolute neutrophil count \\[ANC\\] \\<= 500/mm3).\n* Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender\n* Subjects with current history of malignancy\n* Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident)\n* Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease)\n* Subjects with anemia that in the opinion of the investigator precluded phlebotomy for laboratory studies\n* Subjects who had been exposed to any blood or blood product other than an intravenous immunoglobulin (IGIV), SC immunoglobulin (SCIG), immune serum globulin (ISG) preparations, or albumin within the 6 months prior to study entry.\n* Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SCIG and/or ISG infusions\n* Subjects with IgA deficiency and known anti IgA antibodies\n* Subjects who had received antibiotic therapy for the treatment of infection within 7 days prior to enrollment\n* Subjects who had participated in another clinical study involving an investigational product or device within 28 days prior to study entry\n* Subjects with inability or unwillingness to meet all the requirements of this study\n* If female, pregnancy or lactation at time of study entry"}, 'identificationModule': {'nctId': 'NCT00782106', 'briefTitle': 'Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)', 'orgStudyIdInfo': {'id': '160602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Tolerability of subcutaneous infusions', 'interventionNames': ['Biological: Recombinant human hyaluronidase + immune globulin intravenous']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Tolerability of subcutaneous infusions and pharmacokinetics', 'interventionNames': ['Biological: Recombinant human hyaluronidase + immune globulin intravenous']}], 'interventions': [{'name': 'Recombinant human hyaluronidase + immune globulin intravenous', 'type': 'BIOLOGICAL', 'otherNames': ['IGIV', '10% = Immune Globulin Intraveneous (Human)', '10%', 'rHuPH20 = Recombinant Human Hyaluronidase'], 'description': 'Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered', 'armGroupLabels': ['1']}, {'name': 'Recombinant human hyaluronidase + immune globulin intravenous', 'type': 'BIOLOGICAL', 'otherNames': ['IGIV', '10% = Immune Globulin Intraveneous (Human)', '10%', 'rHuPH20 = Recombinant Human Hyaluronidase'], 'description': '1. IV infusion of IGIV, 10% to determine pharmacokinetics\n2. Intervention as in Arm 1: Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'First Allergy and Clinical Research Center', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'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': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pediatrics Allergy/Immunology Association, PA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}