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NOT YET RECRUITING
NCT07526558
PHASE2

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase II Pilot Study to Assess the Safety and Tolerability of Mast Cell Treatment in Post-tick Bite Illness

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-04-30

Completion Date

2027-01

Last Updated

2026-04-13

Healthy Volunteers

Yes

Interventions

DRUG

Ketotifen

Ketotifen is a mast cell stabilizer and H1 antihistamine administered orally at 1 mg twice daily, with dose escalation to 2 mg twice daily after 30 days.

DRUG

fexofenadine

Fexofenadine is a second-generation H1 antihistamine administered orally at a dose of 180 mg once daily

DRUG

Cromolyn Sodium

Cromolyn sodium is a mast cell stabilizer administered orally at a dose of 200 mg three times daily.

Locations (1)

University of North Carolina

Chapel Hill, North Carolina, United States