Back to resultsPhase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Primary Purpose
Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Intravenous immunoglobulin
Sponsored by
About this trial
This is an interventional treatment trial for Stevens-Johnson Syndrome focused on measuring IVIG in Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Patients with Stevens-Johnson syndrome, Toxic Epidermal Necrolysis unresponsive to corticosteroids
Eligibility Criteria
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..
Sites / Locations
- Nihon Pharmaceutical Co., Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NPB-01
Arm Description
Outcomes
Primary Outcome Measures
disease evaluation score
Secondary Outcome Measures
disease evaluation score
avulsed skin area
erythematous area
Full Information
NCT ID
NCT01696500
First Posted
September 20, 2012
Last Updated
July 1, 2014
Sponsor
Nihon Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01696500
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nihon Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
Keywords
IVIG in Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Patients with Stevens-Johnson syndrome, Toxic Epidermal Necrolysis unresponsive to corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NPB-01
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intravenous immunoglobulin
Primary Outcome Measure Information:
Title
disease evaluation score
Time Frame
7 days
Secondary Outcome Measure Information:
Title
disease evaluation score
Time Frame
4 ,10 ,20 days
Title
avulsed skin area
Time Frame
20 days
Title
erythematous area
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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..
Facility Information:
Facility Name
Nihon Pharmaceutical Co., Ltd
City
Tokyo
ZIP/Postal Code
101-0031
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
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