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

Stevens-Johnson Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696500
• Other study ID #: NPB-01-07/C-01
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2012
• Last updated: July 1, 2014
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2013
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Syndrome
• Toxic Epidermal Necrolysis

Intervention

Drug:
• Intravenous immunoglobulin

Locations

Country	Name	City	State
Japan	Nihon Pharmaceutical Co., Ltd	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease evaluation score		7 days	No
Secondary	disease evaluation score		4 ,10 ,20 days	No
Secondary	avulsed skin area		20 days	No
Secondary	erythematous area		20 days	No