Clinical trial NCT06662812: Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery Registry
Official title: Disease Characteristics and Treatment Patterns of Patients With Sickle Cell Disease in Globin Research Network for Data and Discovery (GRNDaD) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 1665
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

• None identified at this time.

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: