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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213473
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition
Acquired Haemophilia
Register

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Enrollment: 81
Study Start Date: June 2001
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patient with Acquired haemophilia

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • absence and signed consent, haemophilia A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213473

Locations
France
University Hospital of Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Herve LEVESQUE, MD University Hospital, Rouen
  More Information

No publications provided by University Hospital, Rouen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213473     History of Changes
Other Study ID Numbers: 2001/001/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
acquired haemophilia

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 17, 2014