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

• ClinicalTrials.gov Identifier: NCT01696500
• Recruitment Status: Completed
• First Posted: October 1, 2012
• Last Update Posted: July 2, 2014
• Sponsor: Nihon Pharmaceutical Co., Ltd
• Information provided by (Responsible Party): Nihon Pharmaceutical Co., Ltd

Tracking Information

• First Submitted Date: September 20, 2012
• First Posted Date: October 1, 2012
• Last Update Posted Date: July 2, 2014
• Study Start Date: October 2012
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 27, 2012): disease evaluation score [ Time Frame: 7 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 27, 2012)

• disease evaluation score [ Time Frame: 4 ,10 ,20 days ]
• avulsed skin area [ Time Frame: 20 days ]
• erythematous area [ Time Frame: 20 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis

• Intervention: Drug: Intravenous immunoglobulin

Study Arms

Experimental: NPB-01

Intervention: Drug: Intravenous immunoglobulin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 27, 2012): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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..

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01696500
• Other Study ID Numbers: NPB-01-07/C-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nihon Pharmaceutical Co., Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Nihon Pharmaceutical Co., Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Nihon Pharmaceutical Co., Ltd
• Verification Date: October 2013