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

Drug Hypersensitivity Clinical Trial

— DRESS2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00505648
• Other study ID #: 2004/077/HP
• Status: Terminated
• Phase: Phase 3
• First received: July 20, 2007
• Last updated: March 23, 2015
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Drug Hypersensitivity Syndrome
• Hypersensitivity

Intervention

Drug:
• Tegeline®
2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.

Locations

Country	Name	City	State
France	JOLY	Rouen
France	UH-rouen	Rouen	Seine maritime

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year	Yes