Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT00076960
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-10-15
First Post:
2004-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of Stanate (TM) [Stannsoporfin]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007567', 'term': 'Jaundice, Neonatal'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D007565', 'term': 'Jaundice'}, {'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'C055421', 'term': 'tin mesoporphyrin'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2004-02-06', 'studyFirstSubmitQcDate': '2004-02-09', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-02-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['hyperbilirubinemia', 'jaundice', 'tin-mesoporphyrin', 'stannsoporfin', 'exchange transfusion', 'neonatal hyperbilirubinemia'], 'conditions': ['Neonatal Jaundice', 'Hyperbilirubinemia']}, 'referencesModule': {'references': [{'pmid': '11731664', 'type': 'BACKGROUND', 'citation': "Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. doi: 10.1542/peds.108.6.1374."}]}, 'descriptionModule': {'briefSummary': "The purpose of this protocol is to make Stanate (TM) \\[stannsoporfin, tin-mesoporphyrin\\] available to infants who meet the following criteria:\n\n1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;\n2. the infant requires an exchange transfusion; and\n3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Week', 'minimumAge': '12 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': '* Term or near term neonate\n* Elevated serum bilirubin\n* Failing phototherapy\n* Requires exchange transfusion\n* Family refuses exchange transfusion on religious grounds'}, 'identificationModule': {'nctId': 'NCT00076960', 'briefTitle': 'Compassionate Use of Stanate (TM) [Stannsoporfin]', 'nctIdAliases': ['NCT01183988'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions', 'orgStudyIdInfo': {'id': '99A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stanate (TM) [stannsoporfin, tin-mesoporphyrin]', 'type': 'DRUG', 'description': 'Treatment with 4.5 mg/kg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}