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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01696500
Recruitment Status : Completed
First Posted : October 1, 2012
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
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  ICMJE 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  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE Not Provided
Current Responsible Party Nihon Pharmaceutical Co., Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nihon Pharmaceutical Co., Ltd
Original Study Sponsor  ICMJE Same as current
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