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NCT05904093 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease and Hemoglobin S, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05904093: Recruiting Phase 1 study of Sickle Cell Disease and Hemoglobin S, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05904093 is a Phase 1 study of Sickle Cell Disease and Hemoglobin S that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 25 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05904093, a Phase 1 study of Sickle Cell Disease and Hemoglobin S, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Sickle cell disease (SCD) is a genetic disease that causes the body to produce abnormal ( sickled ) red blood cells. SCD can cause anemia and life-threatening complications in the lungs, heart, kidney, and nerves. People with SCD are also at increased risk of forming blood clots in the veins and lungs, but the standard treatments for these clots can cause increased bleeding in people with SCD. Better treatments are needed. Objective: To test a drug (fostamatinib) in people with SCD. Eligibility: People aged 18 to 65 with SCD. Design: Participants will have 6 clinic visits over 12 weeks. Each visit will be 2 to 3 hours. Participants will be screened. They will have a physical exam with blood tests. They will tell the researchers about the medications they take. Fostamatinib is a tablet taken by mouth. Participants will take the drug at home, twice a day, for up to 6 weeks. Participants will have a clinic visit every 2 weeks while they are taking the drug. At each visit they will have a physical exam with blood tests. They will talk about any side effects the drug may be causing. If they are tolerating the drug well after the first 2 weeks, they may begin taking a higher dose. Participants will have a final visit 4 weeks after they stop taking the drug. They will have a physical exam and blood tests; they will be checked for any side effects of the drug.
Primary Outcome
The type, incidence, severity, and relationship to study treatment of AEs and serious adverse events (SAEs) from baseline to Day according to CTCAE.
Conditions Studied
Interventions
- DRUG Fostamatinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-12-18 |
| Est. Completion | 2026-05-14 |
| Phase | Phase 1 |
What NCT05904093 shows while recruiting
NCT05904093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (91% lower).
The record links to 6 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Fostamatinib is the first listed.
NCT05904093 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05904093 about?
NCT05904093 is a clinical study titled "Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease". Background: Sickle cell disease (SCD) is a genetic disease that causes the body to produce abnormal ( sickled ) red blood cells. SCD can cause anemia and life-threatening complications in the lungs, heart, kidney, and nerves. People with SCD are also at increased risk of forming blood clots in the ...
What is the current status of trial NCT05904093?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2024-12-18. Estimated completion is 2026-05-14.
What conditions does trial NCT05904093 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Hemoglobin S, Hb-SS Disease, Disease Sickle Cell Anemia, Sickle Cell Disorders.
What interventions are being tested in trial NCT05904093?
The interventions under investigation include: Fostamatinib (DRUG).
Who is sponsoring clinical trial NCT05904093?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05904093 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05904093's enrollment target sits among peer trials
25 153rd of 213 higher than 55 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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