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

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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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

disease evaluation score

Secondary Outcome

 disease evaluation score

Condition

Stevens-Johnson Syndrome

Intervention

Intravenous immunoglobulin

Study Arms / Comparison Groups

 NPB-01
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

October 2012

Completion Date

June 2014

Primary Completion Date

June 2014

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..
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01696500

Organization ID

NPB-01-07/C-01


Responsible Party

Sponsor

Study Sponsor

Nihon Pharmaceutical Co., Ltd


Study Sponsor

, , 


Verification Date

October 2013