Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)

Phase 3

Terminated

• Conditions: Drug Hypersensitivity

• Registration Number: NCT00505648
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Study Start: 2008-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

JOLY; 🇫🇷 Rouen, France

UH-rouen; 🇫🇷 Rouen, Seine maritime, France