Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-04 @ 7:00 AM
Study NCT ID:
NCT00571467
Status:
TERMINATED
Last Update Posted:
2018-07-20
First Post:
2007-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'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': '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013205', 'term': 'Staphylococcal Protein A'}], 'ancestors': [{'id': 'D000942', 'term': 'Antigens, Bacterial'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Terminated due to recruitment not meeting expectations.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2007-12-10', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the overall safety of PRTX-100 during the 3 month study duration', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Characterize the pharmacokinetics of multiple doses of PRTX-100', 'timeFrame': 'over the first 35 days'}, {'measure': 'Explore immunogenicity of multiple doses of PRTX-10', 'timeFrame': '3 months'}, {'measure': 'Evaluate treatment effect on platelet count', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autoimmune Diseases', 'Bleeding Disorders', 'Blood and Blood Disorders'], 'conditions': ['Idiopathic Thrombocytopenic Purpura (ITP)']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied.\n\nPatients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100. A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. Patients will be followed for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet count(pharmacodynamics).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic ITP \\> 4 months\n* Mean platelet count \\<50 x 10\\^9/L for patients not receiving corticosteroids; or mean platelet count \\>=50 x 10\\^9/L for patients receiving stable dose of corticosteroids\n\nExclusion Criteria:\n\n* Splenectomy within 45 days of screening\n* Rituximab within 6 months prior to screening\n* Cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening\n* IVIG, WinRho or other anti-RhD within 30 days prior to screening'}, 'identificationModule': {'nctId': 'NCT00571467', 'briefTitle': 'Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Protalex, Inc.'}, 'officialTitle': 'An Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)', 'orgStudyIdInfo': {'id': 'PRTX-100A-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRTX-100 (Staphylococcal protein A)', 'description': 'Cohort 1: 0.075 mcg/kg\n\nCohort 2: 0.15 mcg/kg\n\nCohort 3: 0.30 mcg/kg', 'interventionNames': ['Drug: PRTX-100 (Staphylococcal protein A)']}], 'interventions': [{'name': 'PRTX-100 (Staphylococcal protein A)', 'type': 'DRUG', 'otherNames': ['PRTX-100'], 'description': '4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels:\n\n* Cohort 1: 0.075 mcg/kg\n* Cohort 2: 0.15 mcg/kg\n* Cohort 3: 0.30 mcg/kg', 'armGroupLabels': ['PRTX-100 (Staphylococcal protein A)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St. George Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Freemantle Hospital', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Otahuhu', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Middlemore Hospital', 'geoPoint': {'lat': -36.9382, 'lon': 174.84019}}], 'overallOfficials': [{'name': 'Edward Bernton, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Protalex, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protalex, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}