Study of a Potential New Treatment for Patients With Toxi... | NCT00372723

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

NCT00372723

Sponsor

Loyola University

Status

Withdrawn

Last Update Posted

Apr 26, 2013Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Toxic Epidermal Necrolysis

Interventions

Remicaide (infliximab)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow enrollment

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 5, 2006

First Submission Date that Met QC Criteria

Sep 6, 2006

First Posted Date

Sep 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2013

Last Update Posted Date

Apr 26, 2013Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remicaide (infliximab)	Drug	a single dose infusion of 5mg/kg Remicade (Infliximab)

Measure	Description	Time Frame
30 day mortality		30 days

Measure	Description	Time Frame
Safety labs and adverse events		30 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Gamelli, MD	Loyola University Medical Center, Department of Surgery	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013262	Stevens-Johnson Syndrome

Ancestor Terms

ID	Term
D013280	Stomatitis
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D003875	Drug Eruptions

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069285	Infliximab

Ancestor Terms

ID	Term
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided