Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004940
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
Sponsor:
Brigham and Womens Hospital
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria
I Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BWH-FDR000996-DR | None | None | None |