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

This study has been terminated.
(Low enrollment numbers precluded completion of the study during a reasonable amount of time.)
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Brett King, Yale University Identifier:
First received: January 13, 2014
Last updated: October 6, 2016
Last verified: October 2016
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.

Condition Intervention Phase
Toxic Epidermal Necrolysis
Stevens-Johnson Syndrome
Drug: Palifermin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Palifermin Treatment of Toxic Epidermal Necrolysis

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Time-to-cutaneous Re-epithelialization [ Time Frame: The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days ]

Secondary Outcome Measures:
  • Time-to-mucosal Re-epithelialization [ Time Frame: 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 [ Time Frame: The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days ]

Enrollment: 1
Study Start Date: October 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palifermin
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Drug: Palifermin
Other Name: Kepivance


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02037347

United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Brett King
Swedish Orphan Biovitrum
  More Information

Responsible Party: Brett King, Assistant Professor of Dermatology, Yale University Identifier: NCT02037347     History of Changes
Other Study ID Numbers: 0901004673
020901 ( Other Identifier: Bridgeport Hospital )
Study First Received: January 13, 2014
Results First Received: October 6, 2016
Last Updated: October 6, 2016

Additional relevant MeSH terms:
Stevens-Johnson Syndrome
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Skin Diseases
Erythema Multiforme
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders processed this record on April 26, 2017