Trials / Completed
CompletedNCT00004940
Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (planned)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cysteine hydrochloride |
Timeline
- Start date
- 1996-05-01
- Completion
- 2001-09-01
- First posted
- 2000-02-25
- Last updated
- 2015-03-25
Source: ClinicalTrials.gov record NCT00004940. Inclusion in this directory is not an endorsement.