Essential Thrombocythaemia

Our research and trials staff are dedicated and experienced professionals, interested in pushing the boundaries of our knowledge and testing new ideas in practical environments. Use the links below to jump to categorised trials.

PT-1
Type: Multi-centre, randomised trial
Eligibility: Patients with low or intermediate risk ET who are >18 years of age NB: Patients with the following features are classified as high risk and are not eligible for this study any more: age >60 years, platelet count >1500, significant atherosclerotic disease, hypertension or diabetes needing treatment
Study details: Investigates the risk of thrombosis and bleeding in low risk ET patients receiving aspirin. In intermediate risk patients, the study assesses the benefit of using hydroxyurea. All low risk patients (18 – 39 years of age and no high risk features) will receive aspirin 75mg daily. Intermediate risk patients (40 -59 years of age and no high risk features) are randomised to receive aspirin with or without hydroxyurea.
Sanofi Aventis ARD (pending)
Type: Multicentre, randomised, phase II open-label study
Eligibility: Diagnosis of Hydroxyurea resistant or intolerant PV or ET. PC resistance or intolerance to Hydroxyurea is defined as PV patients on. Hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months. Provide written informed consent to participate.
Study details: A randomised study of efficacy and safety or orally administered SAR302503 in patients with Polycythaemia Vera (PV) or Essential Thrombocythaemia (ET) who are resistant or intolerant to Hydroxyurea.  To evaluate the efficacy of daily oral doses of 100,200 and 400mg SAR302503 in patients with PV and ET who are resistant to intolerant to Hydroxyurea (per European LeukaemiaNet criteria)
Sanofi Aventis – JAKARTA
Type: Multicentre, a phase III, randomised, double-blind, placebo-controlled, 3-Arm study
Eligibility: Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT criteria.  Myelofibrosis (MF) classified as high-risk or intermediate risk level 2, as defined by modified IWG-MRT criteria.  Enlarged slpleen, palpable at least 5cm below costal margin.
Study details: A study of patients with intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythaemia Vera Myelofibrosis, or Post-Essential Thrombocythaemia Myelofibrosis with Splenomegaly.  To evaluate the efficacy of daily oral doses of 400mg or 500mg of SAR302503 (investigational medicinal product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contradications for MRI).