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NCT00004940 Clinical Trial

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

Erythropoietic Protoporphyria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004940
Other study ID # 199/13376
Secondary ID BWH-FDR000996-DR
Status Completed
Phase Phase 3
First received February 24, 2000
Last updated March 24, 2015
Start date May 1996
Est. completion date September 2001

Study information
Verified date April 2000
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

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

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cysteine hydrochloride

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital
See also
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Enrolling by invitation NCT05883748 - Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP Phase 2/Phase 3
Completed NCT01097044 - Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) Phase 2
Completed NCT03682731 - Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria