- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00505648
Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin) (DRESS2)
March 23, 2015 updated by: University Hospital, Rouen
Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®
Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome.
Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rouen, France, 76031
- JOLY
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Seine maritime
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Rouen, Seine maritime, France, 76000
- UH-Rouen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pascal JOLY, MD-PHD, Clinique Dermatologique - Hôpital Charles Nicolle
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
July 20, 2007
First Submitted That Met QC Criteria
July 20, 2007
First Posted (Estimate)
July 23, 2007
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004/077/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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