A phase II, open-label, multicentre, pharmacokinetic, pharmacodynamic and safety study of anagrelide hydrochloride in young (18-50 years) and elderly (= 65 years) patients with essential thrombocythaemia.
- Conditions
- Xagrid is an antineoplasic indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
- Registration Number
- EUCTR2004-004058-20-GB
- Lead Sponsor
- Shire Pharmaceutical Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
•Young patients aged 18-50 years inclusive.
•Elderly patients aged 65 years and over.
•Patients must have a confirmed diagnosis of ET.
•Currently receiving anagrelide hydrochloride at a stable maintenance dose = 5 mg/day for at least 4 weeks.
•Body Mass Index (BMI) in the range 16-30 (calculated according to Quetlets method).
•Free of active infection.
•Adequate renal function (creatinine clearance = 50 ml/min).
•Adequate hepatic function (Aspartate amino transferase (AST) and bilirubin = 1.5 x upper limit of normal).
•Performance status 0 or 1 (World Health Organisation (WHO) criteria) with a life expectancy of > 4 months.
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
•Diagnosis of any other myeloproliferative disorder.
•A resting ejection fraction below the limit of the laboratory normal.
•Current use of tobacco in any form (e.g. smoking or chewing).
•Standard blood donation (one pint or more) within 30 days prior to study initiation.
•Plasma donation within 7 days prior to study initiation.
•Abnormal diet or changes in eating habits (per investigator discretion) within 30 days prior to study initiation.
•Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
•Positive urine pregnancy test (for females of child bearing potential) at screening or baseline.
•Patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.
•Haemoglobin <15% below laboratory lower limit of normal
•Subjects confined by either judicial or administrative authorities
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