Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin) (DRESS2)

University Hospital, Rouen

Status and phase: Terminated; Phase 3

Conditions: Drug Hypersensitivity

Treatments: Drug: Tegeline®

Study type: Interventional

Funder types: Other

Identifiers

NCT00505648

2004/077/HP

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)