Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 9:33 AM
Study NCT ID:
NCT01881503
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-13
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C096798', 'term': 'HBOC 201'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2013-06-14', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': '1 week', 'description': 'subjects will receive HBOC-201 to treat life-threatening anemia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['life-threatening anemia', 'blood alternative', 'HBOC'], 'conditions': ['Anemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.englewoodhealth.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option.\n\nHBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.', 'detailedDescription': "i. Initial Dose\n\nFor patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient's circulatory volume is properly controlled and will not impose an inappropriate risk.\n\nii. Subsequent Doses\n\nThe need for additional dose administration should be assessed after each infusion as clinically indicated.\n\nDosing will be stopped if any one of the following occurs:\n\n* resolution of critical ischemia\n* death\n* recovery of native Hemoglobin levels to \\> 6 g/dL,\n* evidence of reticulocytosis"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients \\> = 18 years of age\n2. Patients with hemoglobin \\< = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency\n3. Patients or their Legally Authorized Representatives who are able and willing to provide informed consent\n\nExclusion Criteria:\n\n1. Patients with known hypersensitivity or allergy to beef products\n2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis (on a case by case and quality of life determination)\n3. Patients \\> 80 years of age (on a case by case and quality of life determination)\n4. Patients who are eligible for blood transfusions'}, 'identificationModule': {'nctId': 'NCT01881503', 'briefTitle': 'Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Englewood Hospital and Medical Center'}, 'officialTitle': 'Expanded Access Protocol for the Treatment Use of HBOC-201', 'orgStudyIdInfo': {'id': 'E-12-454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All subjects', 'description': 'all qualifying subjects will receive HBOC-201 (Hemopure) to treat their life-threatening anemia', 'interventionNames': ['Biological: HBOC-201']}], 'interventions': [{'name': 'HBOC-201', 'type': 'BIOLOGICAL', 'otherNames': ['Hemopure'], 'description': "HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.", 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Hospital and Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}], 'overallOfficials': [{'name': 'Carmine Gianatiempo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Englewood Hospital and Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Englewood Hospital and Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'HbO2 Therapeutics LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}