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

Brett King

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Toxic Epidermal Necrolysis; Stevens-Johnson Syndrome

Treatments: Drug: Palifermin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02037347

020901

0901004673

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

Palifermin

Experimental group

Description:

Palifermin 60 micrograms/kg/day IV for 3 consecutive days

Treatment:

Drug: Palifermin