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Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from National Heart, Lung, and Blood Institute (NHLBI)

Record History

The 50 most recent of 338 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Primary endpoint(s) modified Show 4 more changesShow less
    • Enrollment increased: 25 → 35 participants
    • Trial arms changed: 1 → 2
    • Study description expanded, about 14 words
    • Eligibility criteria shortened, about 4 words
  4. Eligibility criteria expanded, about 10 words
    • Study description expanded, about 134 words
    v335
  5. Re-verified, no change to tracked fieldsv334
  6. Primary and study completion pushed from May 14, 2026 to May 14, 2027v333
  7. 3 versions Re-verified since Jan 17, 2026, no change to tracked fieldsv330-v332
  8. Primary completion date: Aug 31, 2025 to May 14, 2026v329
  9. 3 versions Re-verified since Mar 11, 2025, no change to tracked fieldsv326-v328
  10. Trial status: Enrolling by Invitation to Recruitingv325
  11. 2 versions Re-verified since Jan 22, 2025, no change to tracked fieldsv323-v324
  12. Eligibility criteria expanded, about 19 wordsv322
  13. Re-verified, no change to tracked fieldsv321
  14. Start date changed from estimate of Dec 26, 2024 to Dec 18, 2024v320
  15. Start date: Dec 25, 2024 to Dec 26, 2024v319
  16. Start date: Dec 24, 2024 to Dec 25, 2024v318
  17. Start date: Dec 22, 2024 to Dec 24, 2024v317
  18. Start date: Dec 19, 2024 to Dec 22, 2024v316
  19. Start date: Dec 18, 2024 to Dec 19, 2024v315
  20. Start date: Dec 17, 2024 to Dec 18, 2024v314
  21. Start date: Dec 9, 2024 to Dec 17, 2024v313
  22. Start date: Dec 8, 2024 to Dec 9, 2024v312
  23. Start date: Dec 5, 2024 to Dec 8, 2024v311
  24. Start date: Dec 2, 2024 to Dec 5, 2024v310
  25. Start date: Dec 1, 2024 to Dec 2, 2024v309
  26. Start date: Nov 28, 2024 to Dec 1, 2024v308
  27. Start date: Nov 26, 2024 to Nov 28, 2024v307
  28. Start date: Nov 25, 2024 to Nov 26, 2024v306
  29. Start date: Nov 24, 2024 to Nov 25, 2024v305
  30. Start date: Nov 21, 2024 to Nov 24, 2024v304
  31. Start date: Nov 20, 2024 to Nov 21, 2024v303
  32. Start date: Nov 19, 2024 to Nov 20, 2024v302
  33. Start date: Nov 18, 2024 to Nov 19, 2024v301
  34. Start date: Nov 17, 2024 to Nov 18, 2024v300
  35. Start date: Nov 14, 2024 to Nov 17, 2024v299
  36. Start date: Nov 13, 2024 to Nov 14, 2024v298
  37. Start date: Nov 12, 2024 to Nov 13, 2024v297
  38. Start date: Nov 11, 2024 to Nov 12, 2024v296
  39. Start date: Nov 10, 2024 to Nov 11, 2024v295
  40. Start date: Nov 7, 2024 to Nov 10, 2024v294
  41. Start date: Nov 5, 2024 to Nov 7, 2024v293
  42. Start date: Nov 4, 2024 to Nov 5, 2024v292
  43. Start date: Nov 3, 2024 to Nov 4, 2024v291
  44. Start date: Oct 31, 2024 to Nov 3, 2024v290
  45. Start date: Oct 30, 2024 to Oct 31, 2024v289
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05904093
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Sickle Cell Disorders, Sickle Cell Disease, Hemoglobin S, Hb-SS Disease, Disease Sickle Cell Anemia
Related terms Anemia, Sickle Cell, Sickle Cell Trait
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov