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Completed

NCT Number: NCT06662812

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of SCD.
  • Signed consent to participate in GRNDaD registry.

Exclusion criteria

  • None identified at this time.

Treatment and study plan

Primary outcomes

  1. 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

    DMTs included: hydroxyurea, voxelotor, crizanlizumab, l-glutamine, and chronic red cell transfusion.

Secondary outcomes

  1. 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

  2. Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Genotype

    Time frame: Up to 2 years

  3. Number of Patients in the GRNDaD Registry Using Hydroxyurea Categorized by Age

    Time frame: Up to 2 years

  4. Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Gender

    Time frame: Up to 2 years

  5. Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Genotype

    Time frame: Up to 2 years

  6. Number of Patients in the GRNDaD Registry Using Voxelotor Categorized by Age

    Time frame: Up to 2 years

  7. Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Gender

    Time frame: Up to 2 years

  8. Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Genotype

    Time frame: Up to 2 years

  9. Number of Patients in the GRNDaD Registry Using Crizanlizumab Categorized by Age

    Time frame: Up to 2 years

  10. Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Gender

    Time frame: Up to 2 years

  11. Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Genotype

    Time frame: Up to 2 years

  12. Number of Patients in the GRNDaD Registry Using L-glutamine Categorized by Age

    Time frame: Up to 2 years

  13. Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Gender

    Time frame: Up to 2 years

  14. Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Genotype

    Time frame: Up to 2 years

  15. Number of Patients in the GRNDaD Registry Using Chronic Transfusion Categorized by Age

    Time frame: Up to 2 years

  16. Number of Hospital Admissions Categorized by Age

    Time frame: Up to 2 years

  17. Mean Number of Hospital Admissions

    Time frame: Up to 2 years

  18. Number of Emergency Department Visits Categorized by Age

    Time frame: Up to 2 years

  19. Mean Number of Emergency Department Visits

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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