Title
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
A Phase IIIb, Randomized, Open Label Study to Compare the Safety, Efficacy and Tolerability of Anagrelide Hydrochloride Versus Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.
Phase
Phase 4Lead Sponsor
ShireStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Thrombocythemia, HemorrhagicIntervention/Treatment
anagrelide hydroxyurea ...Study Participants
150Essential 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).
Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.
Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.
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%
| Event Type | Organ System | Event Term | Anagrelide | Hydroxyurea |
|---|
The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.
Platelet count was evaluated.
Platelet count was evaluated throughout the study.
A complete response was defined as a platelet count of less than (<) 400x10^9/Liter which was confirmed over 2 consecutive visits at least 28 days apart.
A partial response is defined as a platelet count of 400-600 x 10^9/Liter and a reduction in platelet count of at least 200 x 10^9/Liter from baseline which was confirmed over 2 consecutive visits at least 28 days apart.
Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).
Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).
Thrombohaemorrhagic events are a well-known complication of the underlying essential thrombocythemia (ET) and disease progression. Events such as arterial and venous thrombosis, serious haemorrhage (including gastrointestinal haemorrhage), and death from vascular causes have been reported in participants who received cytoreductive treatment.
White blood cell count was evaluated throughout the study.
Red blood cell count was evaluated throughout the study.
