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

NCT01696500 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis

Interventions

DRUG

Intravenous immunoglobulin

Sponsors & Collaborators

  • Nihon Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696500 on ClinicalTrials.gov