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

This study has been terminated.
(Side effects valuation)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00505648
First Posted: July 23, 2007
Last Update Posted: March 24, 2015
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.
Information provided by (Responsible Party):
University Hospital, Rouen
  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 3

Study Type: Interventional
Study Design: 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®

Resource links provided by NLM:


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 ]

Enrollment: 6
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00505648


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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00505648     History of Changes
Other Study ID Numbers: 2004/077/HP
First Submitted: July 20, 2007
First Posted: July 23, 2007
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Rouen:
Hypersensitivity
Syndrome
Tegeline

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