Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin) (DRESS2)
Primary Purpose
Drug Hypersensitivity
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tegeline®
Sponsored by
About this trial
This is an interventional treatment trial for Drug Hypersensitivity focused on measuring Hypersensitivity, Syndrome, Tegeline
Eligibility 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)
Sites / Locations
- UH-rouen
- JOLY
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00505648
First Posted
July 20, 2007
Last Updated
March 23, 2015
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00505648
Brief Title
Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)
Acronym
DRESS2
Official Title
Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Side effects valuation
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Hypersensitivity
Keywords
Hypersensitivity, Syndrome, Tegeline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegeline®
Intervention Description
2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal JOLY, MD-PHD
Organizational Affiliation
Clinique Dermatologique - Hôpital Charles Nicolle
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH-rouen
City
Rouen
State/Province
Seine maritime
ZIP/Postal Code
76000
Country
France
Facility Name
JOLY
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
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Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)
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