Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
Phase 3
Completed
- Conditions
- Erythropoietic Protoporphyria
- Registration Number
- NCT00004940
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
OBJECTIVES:
I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method