Skip to content

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

Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00505648
Acronym
DRESS2
Enrollment
6
Registered
2007-07-23
Start date
2008-01-31
Completion date
2010-06-30
Last updated
2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Hypersensitivity

Keywords

Hypersensitivity, Syndrome, Tegeline

Brief summary

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

Interventions

DRUGTegeline®

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

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
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 phenotype1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026