Genetic Influence on the distribution of Factor VIII in the patient`s blood with bleeding disorder

• Conditions: Haemophilia A under prophylactic Factor VIII Substitution; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-001669-34-BE
• Lead Sponsor: Med. Univ. Wien, Univ. Klinik f. Kinder- u. Jugendheilkunde, Klin. Abt.f. Pädiatrische Kardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-13
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

This analysis will be performed on a study cohort of approximately 100 severe hemophilia A boys.The boys will be aged between 6 and 18 years and will have severe FVIII deficiency (baseline levels <1%). Only patients using recombinant FVIII products will be included. Following the acquisition of written informed consent the following investigations will be performed on the study participants
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
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

The analysis of factor VIII clearance must be performed at a time when there is no bleeding (bleeding will use up the factor VIII and therefore shorten its circulation time). In addition, there should be no factor VIII antibodies (factor VIII inhibitors) present at the time of testing.

Study & Design

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