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 - ND

• Conditions: Severe hemophilia A (< 1% FVIII:C); MedDRA version: 12.1Level: LLTClassification code 10053753Term: Hemophilia A without inhibitors

• Registration Number: EUCTR2009-010147-14-IT
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-28
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

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 (< 0.6 BU/ml) For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption for a consecutive period beginning at prophylaxis initiation and continuing until the present. Relevant interruption is defined as having received therapy that does not qualify as prophylaxis by the above definition or missing documentation of bleeds and consumption for more than 12 consecutive months. Complete documentation of joints bleeds and their locations prior to start of primary prophylaxis, documentation of the joint status or the joint bleeds and their location of the previous 6 months before start in case of secondary prophylaxis. Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records. The minimum data required is the number and location of joint bleeds, treatment schedule, and Factor VIII consumption over the last 5 years. For the on-demand subjects > 12 bleeds/year in the last 5 years. Written informed consent by subject and parent/legal representative, if < 18 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Test Subject:
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 (ankle, knee) HCV seropositive individuals who underwent interferon therapy during the last 12 months Individuals for whom high-magnetic exposure is contraindicated (see section 7.1) Individuals who, in the opinion of the physician or parent/guardian, would not be able to meet the requirements of the MRI technique Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period Joint replacement For the on-demand treatment group, any period greater than 8 consecutive months having received ≥ 50 IU per kg per week Factor VIII for the prevention of bleeding.

Study & Design

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