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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 April 2015
Main ID:  NCT00004831
Date of registration: 24/02/2000
Prospective Registration: No
Primary sponsor: FDA Office of Orphan Products Development
Public title: Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria
Scientific title:
Date of first enrolment: October 1996
Target sample size: 20
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00004831
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Contacts
Name:     Micheline M Mathews-Roth
Address: 
Telephone:
Email:
Affiliation:  St. Luke's-Roosevelt Hospital Center
Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Documented erythropoietic protoporphyria Determination of
elevated protoporphyrin within the past year Experiencing photosensitivity
--Prior/Concurrent Therapy-- No concurrent use of betacarotene --Patient Characteristics--
Other: Not pregnant or nursing Fertile female patients must use effective contraception
while on study and for 3 weeks thereafter



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Erythropoietic Protoporphyria
Intervention(s)
Drug: cysteine hydrochloride
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
199/13413
SLRH-CU-FDR000996-EF
BWH-FDR000996-EF
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
St. Luke's-Roosevelt Hospital Center
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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