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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Drug: Intravenous immunoglobulin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Study Start Date : October 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rhophylac
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: NPB-01 Drug: Intravenous immunoglobulin


Outcome Measures
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Primary Outcome Measures :
  1. disease evaluation score [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. disease evaluation score [ Time Frame: 4 ,10 ,20 days ]
  2. avulsed skin area [ Time Frame: 20 days ]
  3. erythematous area [ Time Frame: 20 days ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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..
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696500


Locations
Japan
Nihon Pharmaceutical Co., Ltd
Tokyo, Japan, 101-0031
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01696500     History of Changes
Other Study ID Numbers: NPB-01-07/C-01
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: October 2013

Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in Stevens-Johnson syndrome
Toxic Epidermal Necrolysis
Patients with Stevens-Johnson syndrome
Toxic Epidermal Necrolysis unresponsive to corticosteroids

Additional relevant MeSH terms:
Syndrome
Stevens-Johnson Syndrome
Disease
Pathologic Processes
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
 Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs