Table IV.
JOS | ESPRIT | |
---|---|---|
Enrolment | 08/1996–04/2005 | 12/1996–06/1998 |
Enrolled patients, n. (prophylaxis/on-demand) | 65 (32/33) | 45 (23/22) |
Evaluable patients*, n. (prophylaxis/on-demand) | 57 (28/29) | 40 (20/20) |
Median age, years | 1.6 | 4.0 |
Follow-up, months^ | 49 | 120 |
ELEGIBILITY CRITERIA | ||
Age, months | < 30 | < 84 |
FVIII activity | < 2 | < 1 |
Joint bleeds | ≤2 | ≥1° |
Baseline orthopaedic and Pettersson scores | 0 | 0 |
INTERVENTIONS | ||
Prophylactic regimen, FVIII | 25 IU/Kg e.o.d. | 25 IU t.i.w. (target FVIII>1%) |
On-demand treatment, FVIII | 40 IU/Kg, 20 IU/Kg at 24 and 72 hrs and e.o.d. until recovery | ≥ 25 IU/Kg, repeated until complete recovery |
in the JOS, number of patients with radiological data for the assessment of the primary end-point; in the ESPRIT, number of patients following the treatment regimen assigned by randomisation.
median follow-up in the JOS, in which patients were evaluated at the age of 6 years old; planned follow-up in the ESPRIT.
at least one joint or muscle bleed in the 6 months before randomisation.