Hemophilia Clinical Trial
Official title:
Continuation of Children Enrolled in Protocol #95-011, 'A Randomized Prospective Study for the Prevention of Joint Disease in Children With Severe Factor VIII Deficiency'
The original Joint Outcome Study (JOS) enrolled 65 boys with hemophilia from 16 sites
nationally. The subjects were randomized to one of two arms (prophylaxis or an enhanced
episode-based treatment)and were followed prospectively until the age of six. At the age of
six, the proportion of children on each treatment arm who developed bone or cartilage damage
as determined by X-Ray or MRI was assessed. In addition, the function and structure of the
index joints (defined as knees, ankles, and elbows)were evaluated using a physical assessment
scale specially designed for preschool children.
The specific aim of the Joint Outcome Study Continuation (JOSC) is to extend observations of
the children participating in the original JOS until the subjects reach the age of 18 years
in order to determine the natural history of joint development in hemophilia and the impact
of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic
arthropathy. In addition, plasma and DNA will be collected and banked yearly for current and
future studies of biomarkers and predictors of hemophilia outcomes.
n/a
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