|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT02037347 |
|
Date of registration:
|
13/01/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
|
|
Scientific title:
|
Palifermin Treatment of Toxic Epidermal Necrolysis |
|
Date of first enrolment:
|
October 2010 |
|
Target sample size:
|
1 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02037347 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Stevens-Johnson Syndrome
|
|
Toxic Epidermal Necrolysis
|
|
Intervention(s)
|
|
Drug: Palifermin
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
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]
|
|
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]
|
|
Secondary ID(s)
|
|
0901004673
|
|
020901
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|