NCT00004831

Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks. Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up visits at the end of each drug ingestion period.

Conditions

• Erythropoietic Protoporphyria

Interventions

Type	Name	Description
DRUG	cysteine hydrochloride

Timeline

• Start date: 1996-10-01
• Completion: 1998-07-01
• First posted: 2000-02-25
• Last updated: 2015-03-25