A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: April 01, 2022
End Date: June 01, 2025
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:
1. Hematocrit <45%,
2. WBC 4000/μL to 20,000/μL (inclusive), and
3. Platelets 100,000/μL to 1,000,000/μL (inclusive)
- 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.
- Clinically meaningful laboratory abnormalities at Screening.
- Subjects who require phlebotomy at hematocrit levels lower than 45%.
- Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
- Active or chronic bleeding within 2 months prior to randomization.
- History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer.
- Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screen unless the cancer is adequately treated before randomization.
- Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.
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Conditions:
- Polycythemia Vera
- Polycythemia