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

• Conditions: Previously untreated patients with severe (FVIII:C<2%) haemophilia A, no inhibitor activity prior to admission, no concomitant therapy with Interferon, patients registered for regular treatment at the study site, informed consent obtained from parent/legal guardian or patient, no previous treatment with FVIII or blood products containing FVIII, no participation in another clinical trial 4 weeks before study start and during the study.; MedDRA version: 8.0Level: PTClassification code 10016080

• Registration Number: EUCTR2005-004435-22-CZ
• Lead Sponsor: OCTAPHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-29
• Last Update Posted: 12 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 35

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified