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Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria



Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria

For Condition: Erythropoietic Protoporphyria
Status: Completed
Sponsor(s): FDA Office of Orphan Products Development , St. Luke's-Roosevelt Hospital
Synopsis: OBJECTIVES: I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks. Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up visits at the end of each drug ingestion period.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
MichelineMathews-Roth,  Study Chair,  St. Luke's-Roosevelt Hospital


Additional Information:
Study ID Numbers:  199/13413;  BWH-FDR000996-EF,SLRH-CU-FDR000996-EF
Study Start Date: October 1996
Record last reviewed: August 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004831

Other Erythropoietic Protoporphyria Studies:
1. Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria

2. Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria

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