CClinicalTrials.gg
CompletedNCT05833022Updated Apr 27, 2023

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

An observational study in Sickle Cell Disease, sponsored by Novartis Pharmaceuticals. Completed at 11 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Novartis Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
297
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sickle Cell Disease

Browse trials for

03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's enrollment of 297 is above the median of 100 across 287 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

This was a retrospective, noninterventional cohort study

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

Exclusion criteria:

None specified

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
297 participants (actual)
Patient registry
No
06

What researchers measure

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

07

Study locations

11 sites
  • University of Alabama Birmingham
    Birmingham, Alabama 35233, United States
  • Cristiana Care
    Wilmington, Delaware 19801, United States
  • All Children's Hospital
    Saint Petersburg, Florida 33701, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Washington University of St. Louis
    Saint Louis, Missouri 63110, United States
  • Beth Israel Hospital
    East Hanover, New Jersey 07936, United States
  • Montefiore
    New York, New York 10461, United States
  • University of North Carolina
    Chapel Hill, North Carolina 27514, United States
  • University Hospital at Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Ohio State University
    Columbus, Ohio 43203, United States
  • University of Texas (Houston)
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05833022
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 27, 2023
Start date
Jul 30, 2021
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022
Last update
Apr 27, 2023

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion