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

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Mass General Brigham

Status and phase

Completed
Phase 3

Conditions

Erythropoietic Protoporphyria

Treatments

Drug: cysteine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00004940
BWH-FDR000996-DR
199/13376

Details and patient eligibility

About

OBJECTIVES:

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

Full 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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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