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
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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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: NPB-01 |
Drug: Intravenous immunoglobulin |
- disease evaluation score [ Time Frame: 7 days ]
- disease evaluation score [ Time Frame: 4 ,10 ,20 days ]
- avulsed skin area [ Time Frame: 20 days ]
- erythematous area [ Time Frame: 20 days ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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..

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
Japan | |
Nihon Pharmaceutical Co., Ltd | |
Tokyo, Japan, 101-0031 |
Responsible Party: | Nihon Pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT01696500 |
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 |
IVIG in Stevens-Johnson syndrome Toxic Epidermal Necrolysis Patients with Stevens-Johnson syndrome Toxic Epidermal Necrolysis unresponsive to corticosteroids |
Stevens-Johnson Syndrome 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 Immunoglobulins, Intravenous Antibodies gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |