A
non-interventional, post authorisation safety study to continously monitor safety
and pregnancy outcomes in a cohort of at-risk ET subjects exposed to Xagrid compared
to other conventional cytoreductive therapies (EXELS)
Sponsor: Shire
Principal investigator: Gunnar Birgegård
Primary objective: To monitor long term safety of anagrelide (Xagrid)
Status: Ongoing in most European countries. Inclusion stopped April 30 2009.
Research support: Shire
Study design: Observational study of 1000 patients on Xagrid and 2000 patients
on other therapies, mainly hydroxycarbamide. Patients are followed for 5+5 years.
Clinical outcome of ET therapy with regards to blood counts as well as clinical
predefined events are registered every 6 months.
Inclusion criteria: ET patients receiving cytoreductive therapy for ET. Patients
can be newly diagnosed or continuing their pre-prescibed medication of ET. Informed
consent.
Exclusion criteria: Participation in other studies with experimental agents.
