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NCT06148493 · ClinicalTrials.gov registry record
Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 425
- Enrollment target
NCT06148493: Completed study, sponsored by Novartis Pharmaceuticals.
NCT06148493 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 425 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06148493 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 425 participants
- Enrollment target
Study Summary
This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases. Patients were grouped into one of two cohorts depending on the index medication. All patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 30 April 2022 in (Phase 1) were grouped into the asciminib cohort. A data refresh was conducted (Phase 1 refresh) and all patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 29 August 2022 were included in the asciminib cohort. Patients were required to have at least 6 months of continuous data availability prior to the start of treatment and were followed from the start of treatment until the end of available follow-up. The end of available follow up in open source data was defined as 1) last claim date in medical or pharmacy data, OR 2) last day of index pharmacy stability, OR 3) end of study period, whichever came first. While no post-index data availability were required in Phase 1, a subgroup analysis was conducted in patients with at least 3 and 6 months of available follow-up after the index date in Phase 1 refresh. In Phase 2 of the study, patients with no exposure to asciminib and with at least 1 pharmacy claim for imatinib mesylate, dasatinib, nilotinib, bosutinib or ponatinib were indexed to the first new tyrosine kinase inhibitor (TKI) observed between 01 January 2021 and 29 August 2022 and grouped into the other TKI cohort. The index date was the initiation date of the index medication. Patients were required to have linkage to the open-source medical claims database and at least 3 months of available follow-up after the index date.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2022-12-15 |
What the finished NCT06148493 record still lists
NCT06148493 is an observational study that tracks outcomes without assigning an intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT06148493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06148493 about?
NCT06148493 is a clinical study titled "Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database". This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases. Patients were grouped into one of two cohorts depending on the index medication. All patients with at least 1 pharmacy claim for asciminib occurring between 01...
What is the current status of trial NCT06148493?
This trial is currently completed. The enrollment target is 425 participants. The study started on 2022-09-20. Estimated completion is 2022-12-15.
Who is sponsoring clinical trial NCT06148493?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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