Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

Sponsor

Nihon Pharmaceutical Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01696500

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stevens-Johnson Syndrome Toxic Epidermal Necrolysis	Drug: Intravenous immunoglobulin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NPB-01	Drug: Intravenous immunoglobulin

Arm

Intervention/Treatment

Experimental: NPB-01

Drug: Intravenous immunoglobulin

Outcome Measures

Primary Outcome Measures

disease evaluation score [7 days]

Secondary Outcome Measures

disease evaluation score [4 ,10 ,20 days]
avulsed skin area [20 days]
erythematous area [20 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who the disease evaluation score is more than 14 at study medication received.
Patients with corticosteroids over 20mg/day(Prednisolone) at study medication received and continued this treatment more than 2 days.
Patients with treatment effect is insufficiency before study medication received and need additional treatment.
Patients aged more than twenty years old at informed consent.

Exclusion Criteria:

Patients who the SCORTEN score is more than 4 at study medication received.
Patients with multiple organ failure at study medication received.
Patients with severe respiratory disorder at study medication received.
Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.
Patients with malignancy during treatment at informed consent.
Patients treated with corticosteroids dosage is change at 2 days before study medication received.
Patients treated with corticosteroids pulse therapy(including semi-pulse therapy) at 2 days before study medication received.
Patients treated with plasmapheresis at 2 days before study medication received.
Patients treated with high-dose intravenous immunoglobulin at 28 days before informed consent.
Patients with history of shock or hypersensitivity for NPB-01.
Patients with IgA deficiency.
Patients with severe impaired liver function diagnosed virus hepatitis or cirrhosis et al.
Patients with more than 2mg/dL serum creatinine.
Patients with severe cerebro- or cardiovascular disorders.
Patients with high risk of thromboembolism.
Patients with hemolytic/hemorrhagic anemia.
Patients with severe decreased cardiac function.
Patients with decreased platelet less than 75,000/μL..