Treatment of Hypersensitivity Syndrome (DRESS) With Tegel... | NCT00505648

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

NCT00505648

Sponsor

University Hospital, Rouen

Status

Terminated

Last Update Posted

Mar 24, 2015Estimated

Enrollment

6Actual

Phase

Phase 3

Conditions

Drug Hypersensitivity

Interventions

Tegeline®

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Side effects valuation

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 20, 2007

First Submission Date that Met QC Criteria

Jul 20, 2007

First Posted Date

Jul 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tegeline®	Drug	2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.

Outcomes Module

Primary Outcomes

Measure	Description	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		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pascal JOLY, MD-PHD	Clinique Dermatologique - Hôpital Charles Nicolle	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH-rouen		Rouen	Seine maritime	76000	France
JOLY

Condition Browse Module

MeSH Terms

ID	Term
D004342	Drug Hypersensitivity
D006967	Hypersensitivity
D013577	Syndrome

Ancestor Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders
D007154	Immune System Diseases
D004194	Disease

Browse Leaves

Not provided

Browse Branches

Not provided