Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery Registry

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT06662812
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-10-06
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1665

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients in the Globin Research Network for Data and Discovery (GRNDaD) Registry who Received a Disease Modifying Therapy (DMT)	Up to 2 years	DMTs included: hydroxyurea, voxelotor, crizanlizumab, l-glutamine, and chronic red cell transfusion.

Secondary Outcome Measures

Name	Time	Method
Number of Hospital Admissions Categorized by Age	Up to 2 years
Mean Number of Hospital Admissions	Up to 2 years
Number of Emergency Department Visits Categorized by Age	Up to 2 years
Mean Number of Emergency Department Visits	Up to 2 years
Number of Patients in the Globin Research Network for Data and Discovery (GRNDaD) Registry Using Hydroxyurea Categorized by Gender	Up to 2 years
Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Genotype	Up to 2 years
Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Age	Up to 2 years
Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Gender	Up to 2 years
Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Genotype	Up to 2 years
Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Age	Up to 2 years
Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Gender	Up to 2 years
Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Genotype	Up to 2 years
Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Age	Up to 2 years
Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Gender	Up to 2 years
Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Genotype	Up to 2 years
Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Age	Up to 2 years
Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Gender	Up to 2 years
Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Genotype	Up to 2 years
Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Age	Up to 2 years

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States