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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00004940
Collaborator
(none)
50
Enrollment
64
Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. 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
  • Drug: cysteine hydrochloride
 Phase 3

Detailed Description

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Study Start Date :
May 1, 1996
Study Completion Date :
Sep 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Study Chair: Micheline Mary Mathews-Roth, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004940
    Other Study ID Numbers:
    • 199/13376
    • BWH-FDR000996-DR
    First Posted:
    Feb 25, 2000
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Apr 1, 2000
    Keywords provided by , ,
    erythropoietic protoporphyria
    inborn errors of metabolism
    porphyria
    rare disease
    Additional relevant MeSH terms:
    Protoporphyria, Erythropoietic

    Study Results

    No Results Posted as of Mar 25, 2015