Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT00162006
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2003-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjects Who Qualify As Treatment Responders', 'timeFrame': 'Baseline thru Day 15 post treatment', 'description': 'Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.'}], 'secondaryOutcomes': [{'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Screening visit'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 1 (initiation of treatment)'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 2'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 5'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 8'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 11'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 22'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 15'}, {'measure': 'Time to achieve a platelet count > 50 x 109/L', 'timeFrame': 'Day 29 (study termination visit)'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Screening visit'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 1 (initiation visit)'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 2'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 5'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 8'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 11'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 15'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 22'}, {'measure': 'Duration of platelet response', 'timeFrame': 'Day 29 (study termination visit)'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Screening visit'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 1 (initiation visit)'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 2'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 5'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 8'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 11'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 15'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 22'}, {'measure': 'Maximum Platelet Count', 'timeFrame': 'Day 29 (study termination visit)'}, {'measure': 'Number of Adverse Experiences', 'timeFrame': 'Throughout the study period of approximately 11 months'}]}, 'conditionsModule': {'keywords': ['Chronic idiopathic thrombocytopenic purpura'], 'conditions': ['Immune Thrombocytopenic Purpura (ITP)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 and \\<= 65 years\n* ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear\n* Baseline platelet count of \\<= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion\n* No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug\n* For females of child bearing potential, use of adequate birth control measures during study participation\n* Written informed consent\n\nExclusion Criteria:\n\n* Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening\n* Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening\n* Underlying other autoimmune or lymphoproliferative disorder\n* Uncontrolled hypertension\n* Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV\n* Malignancy or history of malignancy\n* Documented selective IgA deficiency (\\<= 10 mg/dL)\n* Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product\n* History of severe adverse reactions to blood and/or blood products\n* Pregnancy or lactation\n* Positivity for HIV, or HCV antibodies, or HBsAg\n* History of unresponsiveness to IVIG defined as a peak increment in platelet count \\<= 20,000/µL coincident with the last IVIG treatment course prior to study entry'}, 'identificationModule': {'nctId': 'NCT00162006', 'briefTitle': 'Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura', 'orgStudyIdInfo': {'id': '160002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Giessen', 'country': 'Germany', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Halle', 'country': 'Germany', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Győr', 'country': 'Hungary', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szombathely', 'country': 'Hungary', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}