Prospective Clinical and Biological Follow-up of Acquired... | NCT00213473

Studies
Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study

NCT00213473

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Jun 18, 2013Estimated

Enrollment

81Actual

Phase

Not provided

Conditions

Acquired Haemophilia
Register

Interventions

Not provided

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

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Not provided

Completion Date

May 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

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

Jun 17, 2013

Last Update Posted Date

Jun 18, 2013Estimated

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

the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. Inclusion criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the help of two french medical society (Internal medicine, french haemostasis and thrombosis society.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Factor VIIIc < 30% and Factor VIII inhibitor > 1 u Bethesda

Exclusion Criteria:

absence and signed consent, haemophilia A

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient with Acquired haemophilia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Herve LEVESQUE, MD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Rouen		Rouen		76031	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21131590	Derived	Wootla B, Christophe OD, Mahendra A, Dimitrov JD, Repesse Y, Ollivier V, Friboulet A, Borel-Derlon A, Levesque H, Borg JY, Andre S, Bayry J, Calvez T, Kaveri SV, Lacroix-Desmazes S. Proteolytic antibodies activate factor IX in patients with acquired hemophilia. Blood. 2011 Feb 17;117(7):2257-64. doi: 10.1182/blood-2010-07-296103. Epub 2010 Dec 3.