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

NCT ID: NCT00213473

Last Updated: 2013-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-06-30

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Haemophilia Register

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* absence and signed consent, haemophilia A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herve LEVESQUE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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University Hospital of Rouen

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 21131590 (View on PubMed)

Other Identifiers

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2001/001/HP

Identifier Type: -

Identifier Source: org_study_id

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