drugset / Trial / NCT05020184
Effect of Oral Cimetidine in the Protoporphyrias
Phase 2
Completed
26 enrolled
Amy K. Dickey, M.D.
The University of Texas Medical Branch, Galveston · collabWake Forest University Health Sciences · collab
RandomizedCrossoverQuadruple-blindTreatment
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
Timeline
- Start
- 2022-06-14
- Primary completion
- 2025-04-24
- Completion
- 2025-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cimetidine | Small molecule | 800 mg | Oral |