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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Immune System Diseases

ClinicalTrials.gov processed this record on November 23, 2014