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Clinical Trials/EUCTR2005-004435-22-CZ
EUCTR2005-004435-22-CZActive, not recruitingNot Applicable

INCIDENCE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEAMOPHILIA A TREATED WITH OCTANATE - AVI-40-3

OCTAPHARMA AG0 sites35 target enrollmentStarted: November 29, 2005Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
35
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

Inclusion Criteria

  • •Previously untreated patients with severe (FVIII:C < 2%) haemophilia A.
  • •Patients who will be registered for regular treatment at the study site.
  • •Patients without any previous treatment with FVIII concentrates or other blood
  • •products containing FVIII.
  • •Patients without any inhibitor activity prior to admission (cut-off: 0.6 B.U.)
  • •Freely given fully informed consent has been obtained from the patient or from
  • •the patient's parent/legal guardian.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients with any defined bleeding disorder other than haemophilia A (e.g. von
  • •Willebrand disease).
  • •Patients with a FVIII:C above 2%.
  • •Patients requiring Interferon therapy
  • •Participation in another clinical study currently or during the past four weeks.

Investigators

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