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 December 2012 by Nihon Pharmaceutical Co., Ltd
Sponsor:
Nihon Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01696500
First received: September 20, 2012
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Stevens-Johnson Syndrome Toxic Epidermal Necrolysis |
Drug: Intravenous immunoglobulin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. |
Resource links provided by NLM:
Further study details as provided by Nihon Pharmaceutical Co., Ltd:
Primary Outcome Measures:
- disease evaluation score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NPB-01 | Drug: Intravenous immunoglobulin |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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..
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696500
Locations
| Japan | |
| Nihon Pharmaceutical Co., Ltd | Recruiting |
| Tokyo, Japan, 101-0031 | |
| Contact: Yasumasa Ogawa kaihatsu@nihon-pharm.co.jp | |
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
More Information
No publications provided
| Responsible Party: | Nihon Pharmaceutical Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT01696500 History of Changes |
| Other Study ID Numbers: | NPB-01-07/C-01 |
| Study First Received: | September 20, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
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:
|
Epidermal Necrolysis, Toxic Staphylococcal Scalded Skin Syndrome Stevens-Johnson Syndrome Drug Eruptions Dermatitis Skin Diseases Drug Hypersensitivity Hypersensitivity Immune System Diseases Drug Toxicity Poisoning Substance-Related Disorders Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections |
Bacterial Infections Skin Diseases, Bacterial Skin Diseases, Infectious Infection Stomatitis Mouth Diseases Stomatognathic Diseases Erythema Multiforme Erythema Skin Diseases, Vesiculobullous Immunoglobulins Antibodies Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013