Brief Title
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Official Title
NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
disease evaluation score
Secondary Outcome
disease evaluation score
Condition
Stevens-Johnson Syndrome
Intervention
Intravenous immunoglobulin
Study Arms / Comparison Groups
NPB-01
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
10
Start Date
October 2012
Completion Date
June 2014
Primary Completion Date
June 2014
Eligibility 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..
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01696500
Organization ID
NPB-01-07/C-01
Responsible Party
Sponsor
Study Sponsor
Nihon Pharmaceutical Co., Ltd
Study Sponsor
, ,
Verification Date
October 2013