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

NCT05833022 | Completed

• 1 other identifier: CSEG101AUS16
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (2)

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

  Up to 12 months

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

  Up to 12 months

Secondary Outcomes (5)

• Number of patients who discontinued treatment with crizanlizumab

  Up to 24 months

• Number of doses of crizanlizumab for patients who discontinued treatment with crizanlizumab

  Up to 24 months

• Reasons for early discontinuation of crizanlizumab treatment

  Up to 24 months

• Number of sickle cell disease (SCD)-related hospitalizations

  Up to 24 months

• Number of SCD-related emergency department (ED) visits

  Up to 24 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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

You may not qualify if:

• None specified

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Cristiana Care

Wilmington, Delaware, 19801, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Washington University of St. Louis

St Louis, Missouri, 63110, United States

Location

Beth Israel Hospital

East Hanover, New Jersey, 07936, United States

Location

Montefiore

New York, New York, 10461, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

University Hospital at Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43203, United States

Location

University of Texas (Houston)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: July 30, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (11)