Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063752
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-07-03
Brief Title:
Safety Study of PI-0824 to Treat Pemphigus Vulgaris
Sponsor:
Peptimmune
Organization:
Peptimmune
Study Overview
Official Title:
An Open-Label Dose-Escalation Phase I Clinical Study to Assess the Safety of PI-0824 in Patient With Pemphigus Vulgaris Requiring Daily Corticosteroid Therapy
Status:
COMPLETED
Status Verified Date:
2005-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe
Detailed Description:
Pemphigus vulgaris PV is an autoimmune disease affecting approximately 40000 people worldwide People with PV produce antibodies that attack the cells of the skin resulting in blisters which if left untreated can lead to devastating infections and discomfort Currently most doctors who treat patients with PV will prescribe high-dose steroids and drugs that suppress the immune system in an effort to decrease the production of these antibodies Unfortunately these medications are associated with serious and difficult side effects that often result in the discontinuation of their use Peptimmune Inc has developed a new therapy for the treatment of PV PI-0824 The goal of this therapy is to reduce the production of antibodies that cause PV blisters by acting only on the disease causing components of the immune system It is hoped that use of PI-0824 will reduce or potentially eliminate the need for high dose steroids and drugs that suppress the immune system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None