A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients

Phase 4CompletedNCT00202644

Shire150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Thrombocythemia, Hemorrhagic

Interventions

AnagrelideDRUG

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.

HydroxyureaDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Locations (15)

University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven

Pleven, Bulgaria

University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology

Sofia, Bulgaria

Outcomes

Primary Outcomes

Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time

The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.

Time frame: Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36

Platelet Count at Month 6

Platelet count was evaluated.

Time frame: Month 6

Secondary Outcomes

Change From Baseline in Platelet Counts at Month 3 and 36

Platelet count was evaluated throughout the study.

Time frame: Baseline and Month 3 and 36

Percentage of Participants With Complete Response

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.

Time frame: Baseline up to Month 36

Percentage of Participants With Partial Response

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 frame: Baseline up to Month 36

Time to Complete Response

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 frame: Baseline up to Month 36

Time to Partial Response

Data from ClinicalTrials.gov

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