Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-07 @ 4:14 AM
Study NCT ID:
NCT04156893
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2019-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RH Genotype Matched RBC Transfusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will receive RH genotype matched red cell units for transfusion. For subjects with a history of stroke/recurrent transient ischemic attack or other indication who require tight control of Hb S, and RH genotyped blood is not available, standard of care serologic matched blood would be administered rather than delaying transfusion and risking higher Hb S level.\n\nFor all subjects, standard of care serologic matched blood would be administered rather than delaying transfusion beyond 7 days'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the treatment efficacy by monitoring the rate of Rh alloimmunization', 'timeFrame': '3.5 years', 'description': 'A primary objective is to determine whether providing RH genotype matched red cell units can reduce or prevent Rh alloimmunization.'}, {'measure': 'Determine the feasibility of identifying sufficient RH genotype matched units', 'timeFrame': '3.5 years', 'description': "A primary objective is to determine the feasibility of identifying sufficient RH genotype matched red cells for chronically transfused patients with SCD with varied RH genotypes. Approximately 20 RHD (Rhesus D) and 20 RHCE (Rhesus CE) variants have been observed in patients with SCD and will determine whether sufficient RH genotyped units can be matched to the patient's own RH genotype."}], 'secondaryOutcomes': [{'measure': 'Determine the rate of non-Rh alloimmunization', 'timeFrame': '3.5 years', 'description': 'A secondary objective is to determine the rate of antibody formation outside the Rh blood group system, such as anti-Kidd or -S/s.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Transfusion'], 'conditions': ['Sickle Cells Disease']}, 'referencesModule': {'references': [{'pmid': '23723452', 'type': 'BACKGROUND', 'citation': 'Chou ST, Jackson T, Vege S, Smith-Whitley K, Friedman DF, Westhoff CM. High prevalence of red blood cell alloimmunization in sickle cell disease despite transfusion from Rh-matched minority donors. Blood. 2013 Aug 8;122(6):1062-71. doi: 10.1182/blood-2013-03-490623. Epub 2013 May 30.'}, {'pmid': '2342522', 'type': 'BACKGROUND', 'citation': 'Vichinsky EP, Earles A, Johnson RA, Hoag MS, Williams A, Lubin B. Alloimmunization in sickle cell anemia and transfusion of racially unmatched blood. N Engl J Med. 1990 Jun 7;322(23):1617-21. doi: 10.1056/NEJM199006073222301.'}, {'pmid': '25203083', 'type': 'BACKGROUND', 'citation': 'Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.'}, {'pmid': '30026182', 'type': 'BACKGROUND', 'citation': 'Chou ST, Evans P, Vege S, Coleman SL, Friedman DF, Keller M, Westhoff CM. RH genotype matching for transfusion support in sickle cell disease. Blood. 2018 Sep 13;132(11):1198-1207. doi: 10.1182/blood-2018-05-851360. Epub 2018 Jul 19.'}, {'pmid': '31021439', 'type': 'BACKGROUND', 'citation': 'Coleman S, Westhoff CM, Friedman DF, Chou ST. Alloimmunization in patients with sickle cell disease and underrecognition of accompanying delayed hemolytic transfusion reactions. Transfusion. 2019 Jul;59(7):2282-2291. doi: 10.1111/trf.15328. Epub 2019 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'To determine the feasibility and efficacy of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.', 'detailedDescription': "This is a Phase 1/2 trial in patients with Sickle Cell Disease requiring chronic red cell transfusions. RH genotyped donor units will be obtained from the New York Blood Center. Patients will be matched with donor units whose RH genotypes predict no foreign Rh protein exposure to the patient. This will provide red cell matching at a level above the current standard of care (serologic C, E, and K matching). Patients will receive RH matched red cells for the duration of their chronic transfusion therapy or up to three years, whichever is shorter. In the pilot phase, we have determined it is feasible to identify RH matched donor units for the patient's RH genotype for every scheduled transfusion. We will now continue to show feasibility as well as determine efficacy by monitoring Rh alloantibody formation.\n\nFor subjects with a history of stroke/recurrent transient ischemic attack or other indication who require tight control of Hb S, and RH genotyped blood is not available, standard of care serologic matched blood would be administered rather than delaying transfusion and risking higher Hb S level.\n\nFor all subjects, standard of care serologic matched blood would be administered rather than delaying transfusion beyond 7 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects age \\>6 months\n* Diagnosis of SCD, all genotypes\n* Require a period of chronic red cell transfusion therapy\n* Subject/parental/guardian permission (informed consent) and if appropriate, child assent\n\nExclusion Criteria:\n\n* Rare RH genotype that would preclude identification of sufficient RBC units\n* Antigen negative requirements due to alloimmunization that would preclude identification of sufficient RBC units\n* Alloimmunized to D antigen\n* Rh alloimmunized patients for whom providing RH genotype matched blood would expose the patient to an antigen that would not be consistent with standard of care and blood bank protocols\n* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures'}, 'identificationModule': {'nctId': 'NCT04156893', 'acronym': 'RBC', 'briefTitle': 'RH Genotype Matched RBC Transfusions', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'RH Genotype Matched Red Cell Transfusions for Patients With Sickle Cell Disease', 'orgStudyIdInfo': {'id': '19-016565'}, 'secondaryIdInfos': [{'id': 'R01HL147879', 'link': 'https://reporter.nih.gov/quickSearch/R01HL147879', 'type': 'NIH'}, {'id': 'R01HL169401', 'link': 'https://reporter.nih.gov/quickSearch/R01HL169401', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RH genotype matched red cell transfusions', 'description': 'Subjects will receive RH genotyped matched red cell units for transfusion in addition to standard serologic C, E, and K antigen matching and being hemoglobin S negative, which is our institutional standard of care for patients with Sickle Cell Disease.', 'interventionNames': ['Biological: Red cell units that are genotype matched at the RHD and RHCE loci']}], 'interventions': [{'name': 'Red cell units that are genotype matched at the RHD and RHCE loci', 'type': 'BIOLOGICAL', 'description': 'Patients will be provided with red cell units that are C, E, and K antigen matched (standard of care for patients with SCD) and genotype matched at the RHD and RHCE loci.', 'armGroupLabels': ['RH genotype matched red cell transfusions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stella Chou, MD', 'role': 'CONTACT', 'email': 'chous@chop.edu', 'phone': '215-590-0947'}, {'name': 'Stella Chou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Stella Chou, MD', 'role': 'CONTACT', 'email': 'chous@chop.edu', 'phone': '215-590-0947'}], 'overallOfficials': [{'name': 'Stella Chou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'For the duration of the study', 'ipdSharing': 'YES', 'description': "Protected Health Information (PHI) will be shared with the New York Blood Center (NYBC) to order blood for the subjects. This will be done using a secure online blood ordering system. The NYBC uses an FDA-approved HIPAA secure system called Blood Enterprise Computer System (BECS) to store patient data and results, including PHI. 3rd party computers at New York Blood Center will also store study data using study identification (ID) numbers. The purpose of having study data coded at NYBC is for specialized testing for red antigens or antibodies for which we will provide some clinical data to assist in the laboratory evaluation. To assure that the transmission of data and samples maintains confidentiality we will used study ID numbers for these samples. The master list will be maintained at the Children's Hospital of Philadelphia (CHOP). The study databases are password protected and on password protected computers at CHOP and at NYBC, that are backed up on the research servers.", 'accessCriteria': 'Only study team members will have access to the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'New York Blood Center', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}