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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: Clinical Trial Phase 1 study, sponsored by Indiana University.
NCT03997903 is a Phase 1 study that was terminated before completion, run by Indiana University. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percent change in Band 3 Phosphorylation tested in red blood cells. Band 3 is a protein found on the membrane of red blood 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 |
Why NCT03997903 stopped before completion
NCT03997903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Imatinib Mesylate is the first listed.
NCT03997903 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03997903's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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