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

Stevens-Johnson Syndrome Clinical Trial

Official title:

Palifermin Treatment of Toxic Epidermal Necrolysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02037347
• Other study ID #: 0901004673
• Secondary ID: 020901
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 13, 2014
• Last updated: August 9, 2016
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis

Intervention

Drug:
• Palifermin

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Brett King	Swedish Orphan Biovitrum

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-cutaneous re-epithelialization		The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days	No
Secondary	Time-to-mucosal re-epithelialization		The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days	No
Secondary	Time-to-cessation of epidermal necrosis		The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days	No