Clinical trial NCT00927667: Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
Official title: A Diagnostic Interventional, Controlled, Cross-sectional Evaluation of Joint Status Using Magnetic Resonance Imaging in Subjects With Severe Hemophilia A Treated With Primary Prophylaxis, Secondary Prophylaxis, or On-demand Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemophilia A
Keywords: Hemophilia A
Joint Status
Bleeds
Magnetic Resonce Imaging
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 156
Sex: MALE
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.


Eligibility criteria: Inclusion Criteria:

* Males aged 12 - 35 years
* Severe hemophilia A ( \< 1 % FVIII:C)
* No history of Factor VIII inhibitory antibody
* 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 and continuing until the present.
* Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
* Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Maximum ankle MRI score
timeFrame: no timeframe (single visit, "snapshot" of the actual joint status)
Secondary outcomes:
measure: Total MRI score of the maximum index joint
timeFrame: no timeframe (single visit, "snapshot" of the actual joint status)
measure: Number of bleeds in each index joint over previous 5 years
timeFrame: no timeframe (medical history status)
measure: Number of total joint bleeds and their locations over previous 5 years
timeFrame: no timeframe (medical history status)
measure: Physical joint score (Gilbert Score)
timeFrame: no timeframe (single visit, "snapshot" of the actual joint status)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Athens
country: Greece
city: Milano
country: Italy
city: Padova
country: Italy
city: Parma
country: Italy
city: Roma
country: Italy
city: A Coruña
country: Spain
city: Valencia
country: Spain
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Canterbury
country: United Kingdom
state: Kent
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: