NCT00063752

Brief Summary

The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2005

First QC Date

July 3, 2003

Last Update Submit

June 23, 2005

Conditions

Pemphigus Vulgaris

Interventions

PI-0824DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

University of California San Francisco

San Francisco, California, 94107, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

East Coast Clinical Research

Salisbury, Massachusetts, 01952, United States

Location

Stony Brook Dermatology Associates

East Setauket, New York, 11733, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

Pemphigus

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 3, 2003

First Posted

July 8, 2003

Study Start

July 1, 2003

Study Completion

March 1, 2005

Last Updated

June 24, 2005

Record last verified: 2005-04

Locations

US(8)