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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02037347
First Posted: January 15, 2014
Last Update Posted: November 30, 2016
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.
Collaborator:
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Brett King, Yale University
  Purpose
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: None (Open Label)
Primary Purpose: Treatment
Official Title: Palifermin Treatment of Toxic Epidermal Necrolysis

Resource links provided by NLM:


Further study details as provided by Brett King, 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

  Eligibility

Information from the National Library of Medicine

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

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
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): NCT02037347


Locations
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
ClinicalTrials.gov Identifier: NCT02037347     History of Changes
Other Study ID Numbers: 0901004673
020901 ( Other Identifier: Bridgeport Hospital )
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: October 6, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016
Last Verified: October 2016

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