Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004940|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.
|Condition or disease||Intervention/treatment||Phase|
|Erythropoietic Protoporphyria||Drug: cysteine hydrochloride||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Study Start Date :||May 1996|
|Estimated Study Completion Date :||September 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004940
|Study Chair:||Micheline Mary Mathews-Roth||Brigham and Women's Hospital|