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

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

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 Overview

• Status: Completed
• Conditions: Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis
• Intervention / Treatment: Drug: Intravenous immunoglobulin

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 101-0031
    • Nihon Pharmaceutical Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease evaluation score	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
disease evaluation score	4 ,10 ,20 days
avulsed skin area	20 days
erythematous area	20 days

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: July 1, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: IVIG in Stevens-Johnson syndrome; Toxic Epidermal Necrolysis; Patients with Stevens-Johnson syndrome; Toxic Epidermal Necrolysis unresponsive to corticosteroids
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Immune System Diseases; Disease; Stomatognathic Diseases; Mouth Diseases; Hypersensitivity; Erythema; Skin Diseases, Vesiculobullous; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Stomatitis; Drug Eruptions; Erythema Multiforme; Drug Hypersensitivity; Syndrome; Stevens-Johnson Syndrome; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: NPB-01-07/C-01