A Phase IIIb, randomised, open label study to compare the safety, efficacy and tolerability of anagrelide hydrochloride versus hydroxyurea in high-risk essential thrombocythaemia patients.

Shire Pharmaceutical Development Ltd.0 个研究点目标入组 184 人开始时间: 2005年6月22日最近更新: 2016年10月3日

适应症

试验速览

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•Patients must have given written informed consent to participate in the study.
•Patients must be aged =18 years
•Previously untreated with a cytoreductive agent.
•Confirmed diagnosis of ET – High Risk Profile
•Satisfactory Medical assessment with no clinically significant and relevant abnormalities.
•If patients are female and of childbearing potential they must have a negative serum pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study. Pregnant or lactating women are excluded from participation.
•Patients must be able willing and likely to comply with the study procedures and restrictions.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with diagnosis of any other myeloproliferative disorder (MPD)
•Any known cause for a secondary thrombocytosis.
•Previous or current treatment with cytoreductive therapy.
•Anticoagulant therapies.
•Anti-aggregant therapies, including aspirin. (Aspirin or other anti-aggregant therapy is allowed up to the point of randomisation).
•Known or suspected intolerance to the study materials.
•Known or suspected Heart Disease
•Left Ventricular Ejection Fraction (LVEF) <55%.
•Treatment with any medications known to alter ventricular ejection fraction.
•Life threatening malignancy or neoplasia which in the opinion of the investigator is unrelated to thrombocythaemia,
•Severe renal impairment defined as creatinine clearance <30ml/min, or severe hepatic impairment defined as elevated transaminases >5xULN.
•Clinically significant abnormal laboratory values (excluding markers of essential thrombocythaemia) will exclude the patient from the study as will known infection with hepatitis B, hepatitis C or HIV.
•Patients with a history of drug/alcohol abuse (within the previous 2 years)
•Patients must not have participated in another investigational study within 30 days prior to enrolment or for a longer duration if specified in local regulations.

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