Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT06662812
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2024-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1665}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients in the Globin Research Network for Data and Discovery (GRNDaD) Registry who Received a Disease Modifying Therapy (DMT)', 'timeFrame': 'Up to 2 years', 'description': 'DMTs included: hydroxyurea, voxelotor, crizanlizumab, l-glutamine, and chronic red cell transfusion.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients in the Globin Research Network for Data and Discovery (GRNDaD) Registry Using Hydroxyurea Categorized by Gender', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Genotype', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Age', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Gender', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Genotype', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Age', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Gender', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Genotype', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Age', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Gender', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Genotype', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Age', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Gender', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Genotype', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Age', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Hospital Admissions Categorized by Age', 'timeFrame': 'Up to 2 years'}, {'measure': 'Mean Number of Hospital Admissions', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Emergency Department Visits Categorized by Age', 'timeFrame': 'Up to 2 years'}, {'measure': 'Mean Number of Emergency Department Visits', 'timeFrame': 'Up to 2 years'}]}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'This was a retrospective observational cohort study. This study was a secondary analysis of individuals with sickle cell disease (SCD) enrolled in the GRNDaD registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of SCD.\n* Signed consent to participate in GRNDaD registry.\n\nExclusion criteria:\n\n• None identified at this time.'}, 'identificationModule': {'nctId': 'NCT06662812', 'briefTitle': 'Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Disease Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery (GRNDaD) Registry', 'orgStudyIdInfo': {'id': 'CSEG101AUS19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GRNDaD Cohort', 'description': 'Patients with sickle cell disease (SCD) who were included in the GRNDaD registry and received a disease modifying therapy (DMT).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}