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NCT03997903 · ClinicalTrials.gov registry record · Phase 1
Imatinib for Pain in Sickle Cell Anemia
A Phase 1 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03997903 is a Phase 1 study that was terminated before completion, run by Indiana University. The registered enrollment target is 7 participants.
The verdict
NCT03997903, a Phase 1 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
In this protocol, the investigators propose to evaluate the biochemical effects of imatinib on sickle red blood cells (RBCs). Patients will be administered imatinib mesylate orally following the guidelines previously established for use of imatinib in other disorders. The biochemical effects of imatinib on sickle RBCs will be examined, including changes in their levels of band 3 tyrosine phosphorylation and the abundances of RBC-derived microparticles in their blood. In addition, the patients will be monitored for symptoms of sickle cell disease (SCD). The investigators expect band 3 tyrosine phosphorylation to decrease dramatically in patients treated with imatinib. The investigators also anticipate a reduction in the numbers of RBC-derived microparticles in circulation (quantitated by assaying the number of glycophorin A positive microparticles in peripheral blood samples by flow cytometry. Most importantly, the investigators expect to see a reduction in the frequency of vaso-occlusive crises, and possibly acute chest syndrome and utilization of opioids. The study duration is planned as 6 months in order to provide adequate time for potential change in the primary endpoints (e.g. percent irreversibly sickled cells).
Interventions
- DRUG Imatinib Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2024-08-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03997903
The ClinicalTrials.gov registry entry for NCT03997903 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Imatinib Mesylate is the first listed.
NCT03997903 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03997903 about?
NCT03997903 is a clinical study titled "Imatinib for Pain in Sickle Cell Anemia". In this protocol, the investigators propose to evaluate the biochemical effects of imatinib on sickle red blood cells (RBCs). Patients will be administered imatinib mesylate orally following the guidelines previously established for use of imatinib in other disorders. The biochemical effects of imat...
What is the current status of trial NCT03997903?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2020-02-26. Estimated completion is 2024-08-06.
What interventions are being tested in trial NCT03997903?
The interventions under investigation include: Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT03997903?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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