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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213473
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
Last Verified: June 2013

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