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.
- Conditions
- Essential thrombocythaemia (ET)MedDRA version: 7.1Level: LLTClassification code 10015493
- Registration Number
- EUCTR2004-004061-15-IE
- Lead Sponsor
- Shire Pharmaceutical Development Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 184
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method