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Completed

NCT Number: NCT05833022

Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: 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 at least five patients who initiated crizanlizumab. Patients who were prescribed crizanlizumab were included in the cohort.

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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

University of Alabama Birmingham, Birmingham, Alabama, United States

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Who can participate

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

Inclusion criteria

  • Any patient with 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 at least 6 doses of medication. The rates could be annualized if total post-index time was <12 months.

Exclusion criteria

None specified

Treatment and study plan

Primary outcomes

  1. Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) prior to treatment with crizanlizumab

    Time frame: Up to 12 months

  2. Percentage of patients who received sickle cell disease treatment (use of hydroxyurea, l-glutamine, chronic transfusion therapy, and voxelotor) during treatment with crizanlizumab

    Time frame: Up to 12 months

Secondary outcomes

  1. Number of patients who discontinued treatment with crizanlizumab

    Time frame: Up to 24 months

  2. Number of doses of crizanlizumab for patients who discontinued treatment with crizanlizumab

    Time frame: Up to 24 months

  3. Reasons for early discontinuation of crizanlizumab treatment

    Time frame: Up to 24 months

  4. Number of sickle cell disease (SCD)-related hospitalizations

    Time frame: Up to 24 months

  5. Number of SCD-related emergency department (ED) visits

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2023
Registry last updated
Apr 27, 2023

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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