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| ID | Type | Description | Link |
|---|---|---|---|
| 020901 | Other Identifier | Bridgeport Hospital |
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Low enrollment numbers precluded completion of the study during a reasonable amount of time.
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| Name | Class |
|---|---|
| Swedish Orphan Biovitrum | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palifermin | Experimental | Palifermin 60 micrograms/kg/day IV for 3 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palifermin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-cutaneous Re-epithelialization | The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-mucosal Re-epithelialization | 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 | The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States | ||
| Yale-New Haven Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Palifermin | Palifermin 60 micrograms/kg/day IV for 3 consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
73-year-old male.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palifermin | Palifermin 60 micrograms/kg/day IV for 3 consecutive days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-to-cutaneous Re-epithelialization | Posted | Number | days | The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palifermin | Palifermin 60 micrograms/kg/day IV for 3 consecutive days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ischemic necrosis | Gastrointestinal disorders | ischemic necrosis of the small bowel |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett King MD | Yale University | 203-785-4092 | brett.king@yale.edu |
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
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| ID | Term |
|---|---|
| D051523 | Fibroblast Growth Factor 7 |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| New Haven |
| Connecticut |
| 06510 |
| United States |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
|
| Secondary | Time-to-mucosal Re-epithelialization | Adverse event experienced by participant precluded measuring this outcome. | Posted | The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days |
|
|
| Secondary | Time-to-cessation of Epidermal Necrosis | Posted | Number | days | The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days |
|
|
|
| 1 |
| 1 |
| 0 |
| 1 |
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| D003872 |
| Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011506 | Proteins |
| D001685 | Biological Factors |