Sickle Cell DiseaseNCT06662825
Real World Patient Characteristics and Treatment Patterns From Crizanlizumab Use: Preliminary Analysis From Select Sickle Cell Centers
An observational study of Sickle Cell Disease, run by Novartis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2022to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: SEG-2022-01 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 patients who had initiated crizanlizumab between 2019 and 2022.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Crizanlizumab Cohort | Patients with sickle cell disease (SCD) who had received at least one dose of crizanlizumab between 2019 and 2022. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at Index Date
Index date was defined as the date of the first crizanlizumab infusion
Measured: Day 1 of Year 2
Gender at Index Date
Index date was defined as the date of the first crizanlizumab infusion
Measured: Day 1 of Year 2
Race
Measured: Day 1 of Year 2
Ethnicity
Measured: Day 1 of Year 2
Insurance Type at Index Date
Index date was defined as the date of the first crizanlizumab infusion
Measured: Day 1 of Year 2
Number of Patients Categorized by Comorbidity
Measured: Baseline
Number of Patients who Received Long-acting Opioid Medication Before Starting Crizanlizumab
Measured: Baseline
Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy Before Starting Crizanlizumab Categorized by Duration of Therapy
Red blood cell transfusion therapy time intervals:
- 0-3 months
- 3-6 months
- 6-12 months
- >12 months
- Unknown
Measured: Baseline
Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy After Starting Crizanlizumab Categorized by Duration of Therapy
Red blood cell transfusion therapy time intervals:
- 0-3 months
- 3-6 months
- 6-12 months
- >12 months
- Unknown
Measured: Up to 1 year
Number of Patients by Type of Disease Modifying Therapy (DMT) Received Pre- and Post-index Date
Index date was defined as the date of the first crizanlizumab infusion.
DMTs included:
- Any SCD specific therapy
- Hydroxyurea
- Voxelotor
- L-Glutamine
- Other
Measured: Up to 2 years
Secondary outcomes (3)
Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment
Measured: 1 year
Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date
Index date was defined as the date of the first crizanlizumab infusion.
Measured: Up to 2 years
Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date
Index date was defined as the date of the first crizanlizumab infusion.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start13 Dec 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662825
- Sponsor's protocol ID
- CSEG101AUS20
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEG-2022-01 Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers
- ClinicalTrials.gov ID
- NCT06662825
- Acronym / sponsor ID
- CSEG101AUS20
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crizanlizumab Cohort | – | –Patients with sickle cell disease (SCD) who had received at least one dose of crizanlizumab between 2019 and 2022. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment
Time frame: 1 year
Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date
Time frame: Up to 2 years
Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Novartis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at Index Date (time frame: Day 1 of Year 2). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.