A Phase 1/2 interventional study of Palifermin in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome, sponsored by Brett King. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-30.
Sponsored by Brett King · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Drug: Palifermin
Also known as: Kepivance
Time-to-cutaneous Re-epithelialization
Time frame: The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days
Time-to-mucosal Re-epithelialization
Time frame: 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
Time frame: The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days
| Milestone | Palifermin |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
| days | Palifermin |
|---|---|
| Time-to-cutaneous Re-epithelialization | 6 |
No measurements were reported for this outcome.
| days | Palifermin |
|---|---|
| Time-to-cessation of Epidermal Necrosis | 3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Palifermin | — | 1/1 (100%) | 0/1 (0%) |
| Event | Palifermin |
|---|---|
| ischemic necrosisGastrointestinal disorders | 1/1 |
73-year-old male.
| Age, Customized(years) | Palifermin |
|---|---|
| Age | 73 |
| Sex/Gender, Customized(participants) | Palifermin |
|---|---|
| Male | 1 |
This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Brett King