Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
Sponsored by Brigham and Women's Hospital
About this trial
Last updated 10 years ago
Study ID
199/13376
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 65 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 24 years ago
What is this trial about?
OBJECTIVES:
I. Determine the long-term efficacy and safety of L-cysteine in the prevention
photosensitivity in patients with erythropoietic protoporphyria.
What are the Participation Requirements?
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Erythropoietic protoporphyria RBC protoporphyrin greater than 50 micrograms/100 dL
--Prior/Concurrent Therapy--
At least 3 months since prior betacarotene or L-cysteine
No concurrent betacarotene
--Patient Characteristics--
- Fertile female patients must use effective contraception for duration of trial and for
3 weeks thereafter
- Not pregnant or nursing