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Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria Clinical research trials and Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria. Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

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



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

For Condition: Erythropoietic Protoporphyria
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Brigham and Women's Hospital
Synopsis: OBJECTIVES: I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 50

Location and Contact Information:

Overall Study Official:
MichelineMathews-Roth,  Study Chair,  Brigham and Women's Hospital


Additional Information:
Study ID Numbers:
  199/13376;  BWH-FDR000996-DR
Study Start Date: May 1996
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004940

Other Erythropoietic Protoporphyria Studies:
1. Phase III Study of L-Cysteine in Patients with Erythropoietic Protoporphyria

2. Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria

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

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