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Effect of Oral Cimetidine in the Protoporphyrias
Sponsor: Amy K. Dickey, M.D.
Summary
Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) result from genetic defects of heme biosynthesis that cause life-long, painful cutaneous sensitivity to light. The objective of this study is to determine the efficacy and safety of oral cimetidine administration for treatment of the protoporphyrias. Efficacy will be based on protoporphyrin levels, photosensitivity, and quality of life questionnaires. Funding Source- FDA OOPD
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2022-06-14
Completion Date
2025-04-24
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Cimetidine
Oral Cimetidine 800mg twice daily.
Placebo
Placebo twice daily
Locations (3)
Massachusetts General Hospital
Boston, Massachusetts, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States