Completed

NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Intravenous immunoglobulin

Drug
Who is being recruted

Dermatitis+14

+ Drug Eruptions

+ Drug Hypersensitivity

Over 20 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: July 2, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01696500
Principal SponsorNihon Pharmaceutical Co., Ltd
Last updated: July 2, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDrug EruptionsDrug HypersensitivityErythemaErythema MultiformeHypersensitivityHypersensitivity, DelayedImmune System DiseasesStomatognathic DiseasesMouth DiseasesSkin DiseasesSkin Diseases, VesiculobullousStomatitisSkin and Connective Tissue DiseasesChemically-Induced DisordersDrug-Related Side Effects and Adverse ReactionsStevens-Johnson Syndrome

Criteria

4 inclusion criteria required to participate
Patients aged more than twenty years old at informed consent
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
18 exclusion criteria prevent from participating
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 high-dose intravenous immunoglobulin at 28 days before informed consent
Patients treated with plasmapheresis at 2 days before study medication received
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Nihon Pharmaceutical Co., Ltd

Tokyo, JapanOpen Nihon Pharmaceutical Co., Ltd in Google Maps
CompletedOne Study Center