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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Drug Hypersensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tegeline®

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No