Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-22 @ 4:07 PM
Study NCT ID:
NCT02274233
Status:
TERMINATED
Last Update Posted:
2015-09-29
First Post:
2014-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}, {'id': 'D017086', 'term': 'beta-Thalassemia'}, {'id': 'D013789', 'term': 'Thalassemia'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624987', 'term': 'SP-420'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Changes in renal function parameters.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Up to 35 days'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of SP-420', 'timeFrame': 'Day 7'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of SP-420', 'timeFrame': 'Day 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chelation', 'Iron Overload', 'Thalassemia', 'Transfusion', 'Iron Chelation'], 'conditions': ['Iron Overload', 'Beta-Thalassemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has iron-overload secondary to β-thalassemia requiring chronic red blood cell transfusions and iron chelation therapy\n* Subject weighs ≥35 kg\n* Subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first dose of SP-420 and for the duration of the study\n* Serum ferritin ≥700 ng/mL and iron saturation ≥70% within 3 weeks before Baseline (Day 1)\n* Cardiac T2\\* score \\>20 msec within 6 months before Baseline (Day 1)\n* Willing to use contraception during the study\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* Serum creatinine greater than the upper limit of normal\n* Platelet count \\<100 × 10\\^9/L\n* Use of another investigational drug within the last 30 days\n* Significant cardiac, renal, hepatic dysfunction or other clinically significant conditions that, in the opinion of the Investigator, would exclude the subject'}, 'identificationModule': {'nctId': 'NCT02274233', 'briefTitle': 'Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sideris Pharmaceuticals'}, 'officialTitle': 'Multicenter, Open-label, Dose-escalation Study of SP-420 in Subjects With Transfusion-dependent β-Thalassemia', 'orgStudyIdInfo': {'id': 'SP-420-702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.5 mg/kg', 'description': '1.5 mg/kg SP-420 once daily for 14 days', 'interventionNames': ['Drug: SP-420']}, {'type': 'EXPERIMENTAL', 'label': '3 mg/kg', 'description': '3 mg/kg SP-420 once daily for 14 days', 'interventionNames': ['Drug: SP-420']}, {'type': 'EXPERIMENTAL', 'label': '6 mg/kg', 'description': '6 mg/kg SP-420 once daily for 14 days', 'interventionNames': ['Drug: SP-420']}, {'type': 'EXPERIMENTAL', 'label': '12 mg/kg', 'description': '12 mg/kg SP-420 once daily for 14 days', 'interventionNames': ['Drug: SP-420']}, {'type': 'EXPERIMENTAL', 'label': '24 mg/kg', 'description': '24 mg/kg SP-420 once daily for 28 days', 'interventionNames': ['Drug: SP-420']}, {'type': 'EXPERIMENTAL', 'label': '9 mg/kg', 'description': '9 mg/kg SP-420 twice daily for 28 days', 'interventionNames': ['Drug: SP-420']}], 'interventions': [{'name': 'SP-420', 'type': 'DRUG', 'armGroupLabels': ['1.5 mg/kg', '12 mg/kg', '24 mg/kg', '3 mg/kg', '6 mg/kg', '9 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Sideris Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Sideris Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sideris Investigative Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sideris Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Sideris Investigative Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Sideris Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Sideris Investigative Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Sideris Pharmaceuticals, Inc. Sideris Pharmaceuticals, Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sideris Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sideris Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}