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

Tracking Information
First Submitted Date ICMJE	September 20, 2012
First Posted Date ICMJE	October 1, 2012
Last Update Posted Date	July 2, 2014
Study Start Date ICMJE	October 2012
Actual Primary Completion Date	June 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 27, 2012)	disease evaluation score [ Time Frame: 7 days ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01696500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (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 ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis
Intervention ICMJE	Drug: Intravenous immunoglobulin
Study Arms	Experimental: NPB-01; Intervention: Drug: Intravenous immunoglobulin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: September 27, 2012)	10
Original Estimated Enrollment ICMJE	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 ICMJE	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..
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Japan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01696500
Other Study ID Numbers ICMJE	NPB-01-07/C-01
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Nihon Pharmaceutical Co., Ltd
Study Sponsor ICMJE	Nihon Pharmaceutical Co., Ltd
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Nihon Pharmaceutical Co., Ltd
Verification Date	October 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP