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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505648
Recruitment Status : Terminated (Side effects valuation)
First Posted : July 23, 2007
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
University Hospital, Rouen

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

Condition or disease Intervention/treatment Phase
Drug Hypersensitivity Drug: Tegeline® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®
Study Start Date : January 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505648

Rouen, Seine maritime, France, 76000
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Pascal JOLY, MD-PHD Clinique Dermatologique - Hôpital Charles Nicolle

Responsible Party: University Hospital, Rouen Identifier: NCT00505648     History of Changes
Other Study ID Numbers: 2004/077/HP
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Rouen:

Additional relevant MeSH terms:
Drug Hypersensitivity
Drug Hypersensitivity Syndrome
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Drug Eruptions
Skin Diseases