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

Brigham and Women's Hospital50 enrolled

Overview

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

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Erythropoietic Protoporphyria

Interventions

cysteine hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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