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

Sponsor
University Hospital, Rouen (Other)
Overall Status
Completed
CT.gov ID
NCT00213473
Collaborator
(none)
81
Enrollment
1
Location
59
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    81 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study
    Study Start Date :
    Jun 1, 2001
    Study Completion Date :
    May 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Factor VIIIc < 30% and Factor VIII inhibitor > 1 u Bethesda
      Exclusion Criteria:
      • absence and signed consent, haemophilia A

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University Hospital of Rouen Rouen France 76031

      Sponsors and Collaborators

      • University Hospital, Rouen

      Investigators

      • Principal Investigator: Herve LEVESQUE, MD, University Hospital, Rouen

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University Hospital, Rouen
      ClinicalTrials.gov Identifier:
      NCT00213473
      Other Study ID Numbers:
      • 2001/001/HP
      First Posted:
      Sep 21, 2005
      Last Update Posted:
      Jun 18, 2013
      Last Verified:
      Jun 1, 2013
      Keywords provided by University Hospital, Rouen
      acquired haemophilia
      Additional relevant MeSH terms:
      Hemophilia A

      Study Results

      No Results Posted as of Jun 18, 2013