Status and phase
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About
This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.
Full description
Phase 2 study in approximately sixty subjects previously diagnosed with Polycythemia Vera who require phlebotomy on a routine basis. There is a 28 week dose finding phase to identify a dose that maintains hematocrit <45%. Subjects who successfully complete the dose finding phase will be entered into a 12 week randomized withdrawal phase to confirm the response. Subsequently patients will enter into an up to 3 year open label extension to investigate long term safety.
Enrollment
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Inclusion and exclusion criteria
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled.
Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled:
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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