NCT01696500

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

September 20, 2012

Last Update Submit

July 1, 2014

Conditions

Stevens-Johnson SyndromeToxic Epidermal Necrolysis

Keywords

IVIG in Stevens-Johnson syndromeToxic Epidermal NecrolysisPatients with Stevens-Johnson syndromeToxic Epidermal Necrolysis unresponsive to corticosteroids

Outcome Measures

Primary Outcomes (1)

  • disease evaluation score

    7 days

Secondary Outcomes (3)

  • disease evaluation score

    4 ,10 ,20 days

  • avulsed skin area

    20 days

  • erythematous area

    20 days

Study Arms (1)

NPB-01

EXPERIMENTAL
Drug: Intravenous immunoglobulin

Interventions

Intravenous immunoglobulinDRUG
NPB-01

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nihon Pharmaceutical Co., Ltd

Tokyo, 101-0031, Japan

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

October 1, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 2, 2014

Record last verified: 2013-10

Locations

JP(1)