Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
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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: | 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. |
- 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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2012 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NPB-01 | Drug: Intravenous immunoglobulin |
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| 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..
Contacts and Locations
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 | |
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 Submitted: | September 20, 2012 |
| First Posted: | October 1, 2012 |
| 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 |