Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Information source: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis
Intervention: Intravenous immunoglobulin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Nihon Pharmaceutical Co., Ltd
Summary
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were
confirmed based on the investigators national diagnostic criteria. Patients who meet all
inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01
(intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy
of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be
evaluated the disease evaluation score et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
events by 20 days after the start of the study treatment.
Clinical Details
Official title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: disease evaluation score
Secondary outcome: disease evaluation scoreavulsed skin area erythematous area
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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..
Locations and Contacts
Nihon Pharmaceutical Co., Ltd, Tokyo 101-0031, Japan
Additional Information
Starting date: October 2012
Last updated: July 1, 2014
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