Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||May 1996|
|Estimated Study Completion Date:||September 2001|
PROTOCOL OUTLINE: This is a phase III study, lasting 3 years; 1996-1999. Patients are administered L-cysteine orally twice daily, 2 capsules with breakfast and 2 with lunch.
Patients fill in questionnaires and diary sheets about their reaction to sunlight exposure, and have blood tested 3 times a year.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004940
|Study Chair:||Micheline Mary Mathews-Roth||Brigham and Women's Hospital|