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

Phase 1

Terminated

• Conditions: Toxic Epidermal Necrolysis; Stevens-Johnson Syndrome
• Interventions: Drug: Palifermin

• Registration Number: NCT02037347
• Lead Sponsor: Brett King

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 available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Results First Submitted: 2016-10-06
• Results First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Results First Posted: 2016-11-30
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Palifermin	Palifermin	Palifermin 60 micrograms/kg/day IV for 3 consecutive days

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States