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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02037347
Recruitment Status : Terminated (Low enrollment numbers precluded completion of the study during a reasonable amount of time.)
First Posted : January 15, 2014
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Collaborator:
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Brett King, Yale University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Toxic Epidermal Necrolysis
Stevens-Johnson Syndrome
Intervention Drug: Palifermin
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Palifermin
Hide Arm/Group Description Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Palifermin
Hide Arm/Group Description Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
73-year-old male.
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Age Number Analyzed 1 participants
73
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 1 participants
1
1.Primary Outcome
Title Time-to-cutaneous Re-epithelialization
Hide Description [Not Specified]
Time Frame The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palifermin
Hide Arm/Group Description:
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: days
6
2.Secondary Outcome
Title Time-to-mucosal Re-epithelialization
Hide Description [Not Specified]
Time Frame The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse event experienced by participant precluded measuring this outcome.
Arm/Group Title Palifermin
Hide Arm/Group Description:
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time-to-cessation of Epidermal Necrosis
Hide Description [Not Specified]
Time Frame The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palifermin
Hide Arm/Group Description:
Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: days
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Palifermin
Hide Arm/Group Description Palifermin 60 micrograms/kg/day IV for 3 consecutive days
All-Cause Mortality
Palifermin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Palifermin
Affected / at Risk (%)
Total   1/1 (100.00%) 
Gastrointestinal disorders   
ischemic necrosis [1]  1/1 (100.00%) 
[1]
ischemic necrosis of the small bowel
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Palifermin
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brett King MD
Organization: Yale University
Phone: 203-785-4092
EMail: brett.king@yale.edu
Layout table for additonal information
Responsible Party: Brett King, Yale University
ClinicalTrials.gov Identifier: NCT02037347    
Other Study ID Numbers: 0901004673
020901 ( Other Identifier: Bridgeport Hospital )
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: October 6, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016