Viewing Study NCT00004359


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Study NCT ID: NCT00004359
Status: COMPLETED
Last Update Posted: 2005-06-24
First Post: 1999-10-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita
Sponsor: National Center for Research Resources (NCRR)
Organization:

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 ID Infos

Secondary ID Type Domain Link View
NU-511 None None View