Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis

Palifermin Treatment of Toxic Epidermal Necrolysis

To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.

Study Overview

• Status: Terminated
• Conditions: Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis
• Intervention / Treatment: Drug: Palifermin

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in more advanced disease necrosis of the entire epidermis
• Epidermal detachment or erythematous to purpuric macules involving more than 10% of body surface area in addition to involvement of the oropharynx; there may be further involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract, respiratory and genitourinary epithelia
• Age of 18 years old or older
• The patient is expected to survive longer than 48 hours

Exclusion Criteria:

• Skin detachment above 90% of the body surface area
• Skin detachment has not progressed during the previous 48 hours
• A positive serum pregnancy test
• Age < 18 years old
• Known hematologic or solid organ malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palifermin; Palifermin 60 micrograms/kg/day IV for 3 consecutive days	Drug: Palifermin; Other Names: Kepivance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time-to-cutaneous Re-epithelialization	The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Time-to-mucosal Re-epithelialization	The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days
Time-to-cessation of Epidermal Necrosis	The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days

Collaborators and Investigators

• Sponsor: Brett King
• Collaborators: Swedish Orphan Biovitrum

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Immune System Diseases; Stomatognathic Diseases; Mouth Diseases; Hypersensitivity; Erythema; Skin Diseases, Vesiculobullous; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Stomatitis; Drug Eruptions; Erythema Multiforme; Drug Hypersensitivity; Stevens-Johnson Syndrome
• Other Study ID Numbers: 0901004673; 020901 (Bridgeport Hospital)