Erythropoietic Protoporphyria Clinical Trial
OBJECTIVES:
I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing
photosensitivity in patients with erythropoietic protoporphyria.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 1998 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented erythropoietic protoporphyria Determination of elevated protoporphyrin within the past year Experiencing photosensitivity --Prior/Concurrent Therapy-- No concurrent use of betacarotene --Patient Characteristics-- Other: Not pregnant or nursing Fertile female patients must use effective contraception while on study and for 3 weeks thereafter |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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FDA Office of Orphan Products Development | St. Luke's-Roosevelt Hospital Center |
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