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

NCT02037347 | Terminated Phase 1 Results

• 2 other identifiers: 0901004673020901
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Toxic Epidermal Necrolysis; Stevens-Johnson Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Palifermin

EXPERIMENTAL

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

Drug: Palifermin

Interventions

Palifermin DRUG

Also known as: Kepivance

Palifermin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brett King: lead
• Swedish Orphan Biovitrum: collaborator

Study Sites (2)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Brett King MD
• Organization: Yale University

brett.king@yale.edu

203-785-4092

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 30, 2016
• Results First Posted: November 30, 2016

Record last verified: 2016-10

Locations

US (2)