Viewing Study NCT00004359



Ignite Creation Date: 2024-05-05 @ 11:08 AM
Last Modification Date: 2024-10-26 @ 9:04 AM
Study NCT ID: NCT00004359
Status: COMPLETED
Last Update Posted: 2005-06-24
First Post: 1999-10-18

Brief Title: Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita
Sponsor: National Center for Research Resources NCRR
Organization: Office of Rare Diseases ORD

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2000-01
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 Evaluate immunomodulation with extracorporeal photochemotherapy ECP in patients with epidermolysis bullosa acquisita

II Investigate the effect of ECP on lymphocyte activity
Detailed Description: PROTOCOL OUTLINE Oral methoxsalen 8-MOP is administered 90 minutes prior to leukapheresis Blood mononuclear cells are exposed to ultraviolet A light for 3 hours then returned to the patient The process is repeated on 2 successive days

Patients are re-treated every 3 to 4 weeks for a total of 6 treatments or until the skin has cleared

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
NU-511 None None None