Trial Outcomes & Findings for Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis (NCT NCT02037347)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days

Results posted on

2016-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Palifermin Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palifermin n=1 Participants Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Age, Customized Age	73 years n=5 Participants
Sex/Gender, Customized Male	1 participants n=5 Participants

PRIMARY outcome

Timeframe: The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days

Outcome measures

Outcome measures
Measure	Palifermin n=1 Participants Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Time-to-cutaneous Re-epithelialization	6 days

SECONDARY outcome

Timeframe: The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days

Population: Adverse event experienced by participant precluded measuring this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days

Outcome measures

Outcome measures
Measure	Palifermin n=1 Participants Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Time-to-cessation of Epidermal Necrosis	3 days

Adverse Events

Palifermin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Palifermin n=1 participants at risk Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Gastrointestinal disorders ischemic necrosis	100.0% 1/1

Other adverse events

Adverse event data not reported

Additional Information

Brett King MD

Yale University

Phone: 203-785-4092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place