Safety Study of PI-0824 to Treat Pemphigus Vulgaris - Tabular View

Tracking Information
First Received Date ^ICMJE	July 3, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	July 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00063752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety Study of PI-0824 to Treat Pemphigus Vulgaris
Official Title ^ICMJE	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
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 40,000 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 Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Condition ^ICMJE	Pemphigus Vulgaris
Intervention ^ICMJE	Drug: PI-0824
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	15
Completion Date	March 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00063752
Responsible Party
Study ID Numbers ^ICMJE	PI-001
Study Sponsor ^ICMJE	Peptimmune
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Peptimmune
Verification Date	April 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP