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Clinical Trials/NCT06662825
NCT06662825
Completed
Not Applicable

SEG-2022-01 Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers

Novartis1 site in 1 country376 target enrollmentDecember 13, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Disease
Sponsor
Novartis
Enrollment
376
Locations
1
Primary Endpoint
Age at Index Date
Status
Completed
Last Updated
last year

Overview

Brief Summary

This was a retrospective cohort study using secondary data from member sites of the National Alliance of Sickle Cell Centers (NASCC) with patients who had initiated crizanlizumab between 2019 and 2022.

Registry
clinicaltrials.gov
Start Date
December 13, 2022
End Date
November 1, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Age at Index Date

Time Frame: Day 1 of Year 2

Index date was defined as the date of the first crizanlizumab infusion

Gender at Index Date

Time Frame: Day 1 of Year 2

Index date was defined as the date of the first crizanlizumab infusion

Race

Time Frame: Day 1 of Year 2

Ethnicity

Time Frame: Day 1 of Year 2

Insurance Type at Index Date

Time Frame: Day 1 of Year 2

Index date was defined as the date of the first crizanlizumab infusion

Number of Patients Categorized by Comorbidity

Time Frame: Baseline

Number of Patients who Received Long-acting Opioid Medication Before Starting Crizanlizumab

Time Frame: Baseline

Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy Before Starting Crizanlizumab Categorized by Duration of Therapy

Time Frame: Baseline

Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown

Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy After Starting Crizanlizumab Categorized by Duration of Therapy

Time Frame: Up to 1 year

Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown

Number of Patients by Type of Disease Modifying Therapy (DMT) Received Pre- and Post-index Date

Time Frame: Up to 2 years

Index date was defined as the date of the first crizanlizumab infusion. DMTs included: * Any SCD specific therapy * Hydroxyurea * Voxelotor * L-Glutamine * Other

Secondary Outcomes

  • Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment(1 year)
  • Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date(Up to 2 years)
  • Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date(Up to 2 years)

Study Sites (1)

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