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Mast Cell Treatment in Post-tick Bite Illness (PTBI)

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase II double-blinded study to assess the safety, tolerability, and feasibility of the mast cell stabilizing medications ketotifen and cromolyn compared to participants receiving standard of care treatment with fexofenadine alone in participants who have persistent symptoms of mast cell activation following a documented tick-borne illness (Ehrlichiosis, Rocky Mountain Spotted Fever, Alpha-gal Syndrome).
Trial Details
NCT Number NCT07526558
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Columbia University
Conditions Post-tick Bite Illness, Mast Cell Stabilizer
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov