A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Confirmed diagnosis of essential thrombocythaemia - high risk profile
- Previously untreated with a cytoreductive agent
- Females of childbearing potential must have a negative urine pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study
Exclusion criteria
- Diagnosis of any other myeloproliferative disorder
- Any known cause for a secondary thrombocytosis
- Anti-coagulant and anti-aggregant therapies
- Known or suspected heart disease
- Left Ventricular Ejection Fraction < 55%
Trial design
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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