Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)

Phase 2

Withdrawn

• Conditions: Toxic Epidermal Necrolysis

• Registration Number: NCT00372723
• Lead Sponsor: Loyola University

Brief Summary

To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.

Detailed Description

This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Admission to burn unit with a histologic diagnosis of TENs

Exclusion Criteria

• Pregnancy
• hypersensitivity to remicaide
• history of heart failure
• documented bacteremia
• history of cancer
• inability to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
30 day mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Safety labs and adverse events	30 days