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The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.
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Inclusion criteria
Patients must have been diagnosed with PV according to the 2016 WHO criteria within 3 years before randomization
Patients must have JAK2V617F-positive disease
Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at screening as follows:
Patients must be in need of treatment at screening, defined by the presence of at least one of the following:
Patients must have normalized HCT (i.e., HCT < 45%) at randomization
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
220 participants in 2 patient groups
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Central trial contact
Domenico Cieri
Data sourced from clinicaltrials.gov
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