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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01696500 |
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Date of registration:
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20/09/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
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Scientific title:
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NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01696500 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients who the disease evaluation score is more than 14 at study medication
received.
2. Patients with corticosteroids over 20mg/day(Prednisolone) at study medication
received and continued this treatment more than 2 days.
3. Patients with treatment effect is insufficiency before study medication received and
need additional treatment.
4. Patients aged more than twenty years old at informed consent.
Exclusion Criteria:
1. Patients who the SCORTEN score is more than 4 at study medication received.
2. Patients with multiple organ failure at study medication received.
3. Patients with severe respiratory disorder at study medication received.
4. Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.
5. Patients with malignancy during treatment at informed consent.
6. Patients treated with corticosteroids dosage is change at 2 days before study
medication received.
7. Patients treated with corticosteroids pulse therapy(including semi-pulse therapy) at
2 days before study medication received.
8. Patients treated with plasmapheresis at 2 days before study medication received.
9. Patients treated with high-dose intravenous immunoglobulin at 28 days before informed
consent.
10. Patients with history of shock or hypersensitivity for NPB-01.
11. Patients with IgA deficiency.
12. Patients with severe impaired liver function diagnosed virus hepatitis or cirrhosis
et al.
13. Patients with more than 2mg/dL serum creatinine.
14. Patients with severe cerebro- or cardiovascular disorders.
15. Patients with high risk of thromboembolism.
16. Patients with hemolytic/hemorrhagic anemia.
17. Patients with severe decreased cardiac function.
18. Patients with decreased platelet less than 75,000/µL..
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stevens-Johnson Syndrome
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Toxic Epidermal Necrolysis
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Intervention(s)
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Drug: Intravenous immunoglobulin
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Primary Outcome(s)
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disease evaluation score
[Time Frame: 7 days]
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Secondary Outcome(s)
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disease evaluation score
[Time Frame: 4 ,10 ,20 days]
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avulsed skin area
[Time Frame: 20 days]
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erythematous area
[Time Frame: 20 days]
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Secondary ID(s)
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NPB-01-07/C-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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