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

Phase 3TerminatedNCT00505648

University Hospital, Rouen6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug Hypersensitivity

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

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (2)

UH-rouen

Rouen, Seine maritime, France

JOLY

Rouen, France

Outcomes

Primary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.