Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
NCT ID: NCT00004940
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
1996-05-31
2001-09-30
Brief Summary
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I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.
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Detailed Description
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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
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Study Design
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TREATMENT
Interventions
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cysteine hydrochloride
Eligibility Criteria
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Inclusion 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
18 Years
65 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Principal Investigators
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Micheline Mary Mathews-Roth
Role: STUDY_CHAIR
Brigham and Women's Hospital
Other Identifiers
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BWH-FDR000996-DR
Identifier Type: -
Identifier Source: secondary_id
199/13376
Identifier Type: -
Identifier Source: org_study_id
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