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

This study has been terminated.
(Side effects valuation)
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00505648
First received: July 20, 2007
Last updated: June 11, 2009
Last verified: June 2009
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®

Resource links provided by NLM:

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:
    Drug: Tegeline®
    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
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

No publications provided

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

Keywords provided by University Hospital, Rouen:
Hypersensitivity
Syndrome
Tegeline

Additional relevant MeSH terms:
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013