Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery Registry
October 27, 2024 updated by: Novartis
Disease Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery (GRNDaD) Registry
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1665
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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East Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This was a retrospective, noninterventional cohort study.
Description
Inclusion criteria:
- Diagnosis of SCD.
- Signed consent to participate in GRNDaD registry.
Exclusion criteria:
• None identified at this time.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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GRNDaD Cohort
Patients with sickle cell disease (SCD) who were included in the GRNDaD registry and received a disease modifying therapy (DMT).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Patients in the Globin Research Network for Data and Discovery (GRNDaD) Registry who Received a Disease Modifying Therapy (DMT)
Time Frame: Up to 2 years
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DMTs included: hydroxyurea, voxelotor, crizanlizumab, l-glutamine, and chronic red cell transfusion.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of Patients in the Globin Research Network for Data and Discovery (GRNDaD) Registry Using Hydroxyurea Categorized by Gender
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Genotype
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Age
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Gender
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Genotype
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Age
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Gender
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Genotype
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Age
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Gender
Time Frame: Up to 2 years
|
Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Genotype
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Age
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Gender
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Genotype
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Age
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of Hospital Admissions Categorized by Age
Time Frame: Up to 2 years
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Up to 2 years
|
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Mean Number of Hospital Admissions
Time Frame: Up to 2 years
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Up to 2 years
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Number of Emergency Department Visits Categorized by Age
Time Frame: Up to 2 years
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Up to 2 years
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Mean Number of Emergency Department Visits
Time Frame: Up to 2 years
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Up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2021
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
October 27, 2024
First Submitted That Met QC Criteria
October 27, 2024
First Posted (Actual)
October 29, 2024
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 27, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSEG101AUS19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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