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

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Brief Title

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

Official Title

Palifermin Treatment of Toxic Epidermal Necrolysis

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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Time-to-cutaneous Re-epithelialization

Secondary Outcome

 Time-to-mucosal Re-epithelialization

Condition

Toxic Epidermal Necrolysis

Intervention

Palifermin

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1

Start Date

October 2010

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02037347

Organization ID

0901004673

Secondary IDs

020901

Responsible Party

Sponsor-Investigator

Study Sponsor

Brett King

Collaborators

 Swedish Orphan Biovitrum

Study Sponsor

, , 


Verification Date

October 2016