A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

ID#: NCT05210790

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: April 01, 2022

End Date: June 01, 2025

Contact Information:
Study Director
1-888-899-1543
Summary: 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.
Eligibility: 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:

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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