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NCT00213473 Clinical Trial

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

Acquired Haemophilia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00213473
Other study ID # 2001/001/HP
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated June 17, 2013
Start date June 2001
Est. completion date May 2006

Study information
Verified date June 2013
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- absence and signed consent, haemophilia A

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France University Hospital of Rouen Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

See also
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