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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Yale University
Sponsor:
Collaborator:
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Brett King, Yale University
ClinicalTrials.gov Identifier:
NCT02037347
First received: January 13, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: October 2010
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037347

Contacts
Contact: Brett A King, MD, PhD 203-737-4825 brett.king@yale.edu

Locations
United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06610
Sub-Investigator: Alisa Savetamal, MD         
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Brett A King, MD, PhD         
Sponsors and Collaborators
Brett King
Swedish Orphan Biovitrum
  More Information

No publications provided

Responsible Party: Brett King, Assistant Professor of Dermatology, Yale University
ClinicalTrials.gov Identifier: NCT02037347     History of Changes
Other Study ID Numbers: 0901004673, 020901
Study First Received: January 13, 2014
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Drug Hypersensitivity
Epidermal Necrolysis, Toxic
Staphylococcal Scalded Skin Syndrome
Stevens-Johnson Syndrome
Drug Eruptions
Dermatitis
Skin Diseases
Hypersensitivity
Immune System Diseases
Drug Toxicity
Poisoning
Substance-Related Disorders
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on July 22, 2014