Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin) - Full Text View

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

This study has been terminated.

( Side effects valuation )

First Received: July 20, 2007 Last Updated: June 11, 2009 History of Changes

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00505648

Purpose

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

Condition	Intervention	Phase
Drug Hypersensitivity	Drug: Tegeline®	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505648

Locations

France
JOLY
Rouen, France, 76031
France, Seine maritime
UH-rouen
Rouen, Seine maritime, France, 76000

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

Pascal JOLY, MD-PHD

Clinique Dermatologique - Hôpital Charles Nicolle

More Information

No publications provided

Responsible Party:	Rouen University Hospital ( PAIRE Christian / managing Director )
Study ID Numbers:	2004/077/HP
Study First Received:	July 20, 2007
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00505648 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Rouen:

Hypersensitivity
Syndrome
Tegeline

Study placed in the following topic categories:

Antibodies
Hypersensitivity
Drug Hypersensitivity
Eosinophilia
Immunoglobulins

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Drug Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009