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

NCT ID: NCT02037347

Last Updated: 2016-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Toxic Epidermal Necrolysis Stevens-Johnson Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Palifermin

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

Group Type EXPERIMENTAL

Palifermin

Intervention Type DRUG

Interventions

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Palifermin

Intervention Type DRUG

Other Intervention Names

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Kepivance

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role collaborator

Brett King

OTHER

Sponsor Role lead

Responsible Party

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Brett King

Assistant Professor of Dermatology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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020901

Identifier Type: OTHER

Identifier Source: secondary_id

0901004673

Identifier Type: -

Identifier Source: org_study_id