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

This study has been withdrawn prior to enrollment.
(slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372723
First Posted: September 7, 2006
Last Update Posted: April 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Loyola University
  Purpose
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.

Condition Intervention Phase
Toxic Epidermal Necrolysis Drug: Remicaide (infliximab) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • 30 day mortality [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Safety labs and adverse events [ Time Frame: 30 days ]

Enrollment: 0
Study Start Date: July 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Remicaide (infliximab)
    a single dose infusion of 5mg/kg Remicade (Infliximab)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372723


Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Richard Gamelli, MD Loyola University Medical Center, Department of Surgery
  More Information

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00372723     History of Changes
Other Study ID Numbers: 108983
First Submitted: September 5, 2006
First Posted: September 7, 2006
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Loyola University:
toxic epidermal necrlysis
ten

Additional relevant MeSH terms:
Stevens-Johnson Syndrome
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents