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

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.
 
ClinicalTrials.gov Identifier: NCT02037347
Recruitment Status : Terminated (Low enrollment numbers precluded completion of the study during a reasonable amount of time.)
First Posted : January 15, 2014
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Collaborator:
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Brett King, Yale University

Tracking Information
First Submitted Date  ICMJE January 13, 2014
First Posted Date  ICMJE January 15, 2014
Results First Submitted Date  ICMJE October 6, 2016
Results First Posted Date  ICMJE November 30, 2016
Last Update Posted Date November 30, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02037347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
Official Title  ICMJE Palifermin Treatment of Toxic Epidermal Necrolysis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Toxic Epidermal Necrolysis
  • Stevens-Johnson Syndrome
Intervention  ICMJE Drug: Palifermin
Other Name: Kepivance
Study Arms  ICMJE Experimental: Palifermin
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Intervention: Drug: Palifermin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 9, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2014)
5
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02037347
Other Study ID Numbers  ICMJE 0901004673
020901 ( Other Identifier: Bridgeport Hospital )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brett King, Yale University
Study Sponsor  ICMJE Brett King
Collaborators  ICMJE Swedish Orphan Biovitrum
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP