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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®

About this trial

This is an interventional treatment trial for Drug Hypersensitivity focused on measuring Hypersensitivity, Syndrome, Tegeline

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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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