Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01461018
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2011-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
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'}, {'id': 'C558471', 'term': 'Hizentra'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized rate of infection episodes', 'timeFrame': 'Up to 36 months'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events (AEs)', 'timeFrame': 'Up to 36 months'}, {'measure': 'Percentage of subjects with adverse events (AEs)', 'timeFrame': 'Up to 36 months'}, {'measure': 'Rate of AEs per infusion', 'timeFrame': 'Up to 36 months'}, {'measure': 'Annualized rate of clinically documented serious bacterial infections (SBIs)', 'timeFrame': 'Up to 36 months', 'description': 'SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess.'}, {'measure': 'Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections', 'timeFrame': 'Up to 36 months'}, {'measure': 'Number of days of hospitalization due to infections', 'timeFrame': 'Up to 36 months'}, {'measure': 'Duration of use of antibiotics for infection prophylaxis and treatment', 'timeFrame': 'Up to 36 months'}, {'measure': 'Median serum IgG concentration', 'timeFrame': 'Up to 36 months'}]}, 'conditionsModule': {'keywords': ['Immune globulin subcutaneous', 'SCIG', 'Primary immunodeficiency', 'PID'], 'conditions': ['Primary Immune Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07\\_001CR (NCT01458171).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have completed the preceding follow-up study ZLB07\\_001CR.\n* Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and \\<20 years of age at the time of obtaining informed consent), according to the competencies of the subject.\n\nExclusion Criteria:\n\n* Pregnancy or nursing mother.\n* Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07\\_001CR.\n* Subjects who are planning to donate blood during the study.\n* Known or suspected antibodies to the IMP, or to excipients of the IMP.\n* Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.'}, 'identificationModule': {'nctId': 'NCT01461018', 'briefTitle': 'Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency', 'orgStudyIdInfo': {'id': 'IgPro20_3006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IgPro20', 'interventionNames': ['Biological: Immune globulin subcutaneous (Human)']}], 'interventions': [{'name': 'Immune globulin subcutaneous (Human)', 'type': 'BIOLOGICAL', 'otherNames': ['Hizentra'], 'description': 'IgPro20 is a 20% (weight per volume \\[w/v\\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.', 'armGroupLabels': ['IgPro20']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '260-8677', 'city': 'Chiba', 'state': 'Chiba Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '812-8582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '502-8558', 'city': 'Gifu', 'state': 'Gifu Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Study Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '570-8507', 'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'zip': '343-8555', 'city': 'Koshigaya', 'state': 'Saitama Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'zip': '359-8513', 'city': 'Tokorozawa', 'state': 'Saitama Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'zip': '113-8519', 'city': 'Bunkyō City', 'state': 'Tokyo Metropolitan', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}], 'overallOfficials': [{'name': 'Yusuke Watanabe', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}