A diagnostic interventional, controlled, cross-sectional evaluation of joint status using MRI in subjects with severe hemophilia A treated with primary prophylaxis, secondary prophylaxis, or on-demand therapy - MRI

Bayer Healthcare AG0 sites250 target enrollmentMarch 6, 2009

Overview

No summary available.

Registry

who.int

Start Date

March 6, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•Test subjects (for MRI quality assessment)
•\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-
•Males aged 18 \- 35 years
•Severe hemophilia A (\< 1% FVIII:C)
•Written informed consent by subject
•Investigation subjects only (subjects participating in the full investigation)
•\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-
•Males aged 12 \- 35 years
•Severe hemophilia A ( \< 1 % FVIII:C)
•No history of Factor VIII inhibitory antibody measured using the Bethesda assay

•Test subjects (for MRI quality assessment)
•\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-
•Individuals for whom high\-magnetic exposure is contraindicated
•Individuals who, in the opinion of the physician, would not be able to meet the
•requirements of the MRI technique
•Investigation subjects only (subjects participating in the full investigation)
•\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-
•Individuals with other coagulopathies (e.g., von Willebrand disease)
•HIV seropositive subjects
•Individuals for whom the most clinically severe joint is not one of the 4 index joints