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

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:

Genetics Home Reference related topics: Stevens-Johnson syndrome/toxic epidermal necrolysis

MedlinePlus related topics: Steroids

Drug Information available for: Rhophylac

Genetic and Rare Diseases Information Center resources: Toxic Epidermal Necrolysis Stevens-Johnson Syndrome Erythema Multiforme

U.S. FDA Resources

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
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


Ages Eligible for Study:	20 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696500

Locations


Japan
Nihon Pharmaceutical Co., Ltd
Tokyo, Japan, 101-0031

Sponsors and Collaborators

Nihon Pharmaceutical Co., Ltd

More Information


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:	July 1, 2014
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:


Syndrome Stevens-Johnson Syndrome Staphylococcal Scalded Skin 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 Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Skin Diseases, Bacterial Skin Diseases, Infectious Infection Immunoglobulins, Intravenous Gamma-Globulins Rho(D) Immune Globulin Immunoglobulins

ClinicalTrials.gov processed this record on September 30, 2016