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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen

Criteria

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)