NCT00505648

Brief Summary

Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

July 20, 2007

Last Update Submit

March 23, 2015

Conditions

Drug Hypersensitivity

Keywords

HypersensitivitySyndromeTegeline

Outcome Measures

Primary Outcomes (1)

  • express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype

    1 year

Interventions

Tegeline®DRUG

2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18
  • Cutaneous and/or mucous eruption
  • Polyadenopathy
  • Body temperature \> 38°C
  • Hematology disorders : Hypereosinophily \> 1.5 G/l, lymphocytosis \> 5G/l, atypical blood lymphocytes
  • Consent obtained from patient

You may not qualify if:

  • Age \< 18
  • No consent obtained from patient
  • IgV allergy
  • Dress with very sérious visceral attack and vital diagnostic (sharp cardiac insufficiency, sharp respiratory insufficiency, hepatic insufficiency, sharp renal insufficiency)
  • Oral therapy or immunosuppressive therapy (Methotrexate, cyclosporine, cyclophosphamide, etc.)
  • IgA deficiency,
  • MCI \>=35
  • Sharp renal insufficiency before Dress with creatinaemia \< 60 ml/min (Cockroft)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UH-rouen

Rouen, Seine maritime, 76000, France

Location

JOLY

Rouen, 76031, France

Location

MeSH Terms

Conditions

Drug HypersensitivityHypersensitivitySyndrome

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersImmune System DiseasesDiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pascal JOLY, MD-PHD

    Clinique Dermatologique - Hôpital Charles Nicolle

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

FR(2)