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Completed

NCT Number: NCT06662825

Real World Patient Characteristics and Treatment Patterns From Crizanlizumab Use: Preliminary Analysis From Select Sickle Cell Centers

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.

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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

Age range

16 year and older

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

  • Any patient with a diagnosis of SCD based on high performance liquid chromatography (HPLC) or hemoglobin electrophoresis at treating institution.
  • Treatment order for crizanlizumab; Index date was defined as the date for the first crizanlizumab treatment.
  • At least 12 months of available electronic medical record (EMR) data pre-index date (baseline).
  • Patients must have received at least one dose of crizanlizumab.
  • For inclusion in pre/post analysis of effectiveness, patients must have received crizanlizumab for at least 12 months.

Exclusion criteria

None identified.

Treatment and study plan

Primary outcomes

  1. Age at Index Date

    Time frame: Day 1 of Year 2

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

  2. Gender at Index Date

    Time frame: Day 1 of Year 2

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

  3. Race

    Time frame: Day 1 of Year 2

  4. Ethnicity

    Time frame: Day 1 of Year 2

  5. Insurance Type at Index Date

    Time frame: Day 1 of Year 2

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

  6. Number of Patients Categorized by Comorbidity

    Time frame: Baseline

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

    Time frame: Baseline

  8. 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

  9. 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

  10. 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

  1. Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment

    Time frame: 1 year

  2. Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date

    Time frame: Up to 2 years

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

  3. Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date

    Time frame: Up to 2 years

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2022
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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