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

This study is currently recruiting participants.
Verified October 2013 by Nihon Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01696500
First received: September 20, 2012
Last updated: October 15, 2013
Last verified: October 2013

September 20, 2012
October 15, 2013
October 2012
January 2014   (final data collection date for primary outcome measure)
disease evaluation score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01696500 on ClinicalTrials.gov Archive Site
  • disease evaluation score [ Time Frame: 4 ,10 ,20 days ] [ Designated as safety issue: No ]
  • avulsed skin area [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • erythematous area [ Time Frame: 20 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis
Drug: Intravenous immunoglobulin
Experimental: NPB-01
Intervention: Drug: Intravenous immunoglobulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2014
January 2014   (final data collection date for primary outcome measure)

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..
Both
20 Years and older
No
Not Provided
Japan
 
NCT01696500
NPB-01-07/C-01
No
Nihon Pharmaceutical Co., Ltd
Nihon Pharmaceutical Co., Ltd
Not Provided
Not Provided
Nihon Pharmaceutical Co., Ltd
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP