Status:
ACTIVE_NOT_RECRUITING
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
Lead Sponsor:
Protagonist Therapeutics, Inc.
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed 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 wil...
Eligibility Criteria
Inclusion
- Main 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:
- Hematocrit \<45%,
- WBC 4000/μL to 20,000/μL (inclusive), and
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT05210790
Start Date
April 1 2022
End Date
June 1 2027
Last Update
August 7 2025
Active Locations (184)
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1
Infirmary Cancer Care
Mobile, Alabama, United States, 36607
2
Palo Verde Hematology-Oncology
Glendale, Arizona, United States, 85304
3
City of Hope Medical Center, Duarte
Duarte, California, United States, 91010
4
California Cancer Associates for Research and Excellence - Fresno
Fresno, California, United States, 93720