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

NCT ID: NCT00004940

Last Updated: 2015-03-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

2001-09-30

Brief Summary

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OBJECTIVES:

I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.

Detailed Description

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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

Conditions

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Erythropoietic Protoporphyria

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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cysteine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

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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