Back to resultsStudy to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
Primary Purpose
Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Palifermin
Sponsored by
About this trial
This is an interventional treatment trial for Toxic Epidermal Necrolysis
Eligibility 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
Sites / Locations
- Bridgeport Hospital
- Yale-New Haven Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Palifermin
Arm Description
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Outcomes
Primary Outcome Measures
Time-to-cutaneous Re-epithelialization
Secondary Outcome Measures
Time-to-mucosal Re-epithelialization
Time-to-cessation of Epidermal Necrosis
Full Information
NCT ID
NCT02037347
First Posted
January 13, 2014
Last Updated
October 6, 2016
Sponsor
Brett King
Collaborators
Swedish Orphan Biovitrum
1. Study Identification
Unique Protocol Identification Number
NCT02037347
Brief Title
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
Official Title
Palifermin Treatment of Toxic Epidermal Necrolysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment numbers precluded completion of the study during a reasonable amount of time.
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brett King
Collaborators
Swedish Orphan Biovitrum
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palifermin
Arm Type
Experimental
Arm Description
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Palifermin
Other Intervention Name(s)
Kepivance
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
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