Orchard Healthcare Research Inc. | Skokie, IL
Status and phase
Conditions
Treatments
About
The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.
Full description
Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks. Approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria.
Male and female subjects aged 18 (or the country specific minimum age of consent >18) years or older.
Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera.
At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization.
CBC values immediately prior to randomization:
Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen.
Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.
Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria.
Primary purpose
Allocation
Interventional model
Masking
250 participants in 2 patient groups
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Central trial contact
Study Director
Data sourced from clinicaltrials.gov
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