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Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria

Erythropoietic Protoporphyria Clinical Trial

Clinical Trial Summary

OBJECTIVES:

I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.

Clinical Trial 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 ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004940
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase Phase 3
Start date May 1996
Completion date September 2001
View Details
See also
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Completed NCT01097044 - Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) Phase 2
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