A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
a study on Polycythemia Vera
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA UCSD UCSF
- Dates
- study startedcompletion around
Description
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.
Official Title
A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera
Details
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.
Keywords
Polycythemia Vera, PV, Polycythemia, Rusfertide
Eligibility
You can join if…
Open to people ages 18 years and up
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.
You CAN'T join if...
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.
Locations
- University of California, San Diego (UCSD) - Moores Cancer Center
accepting new patients
La Jolla California 92037 United States - University of California, Los Angeles (UCLA) - Medical Center
accepting new patients
Los Angeles California 90095 United States - University of California, San Francisco
accepting new patients
San Francisco California 94117 United States - California Cancer Associates for Research and Excellence - Fresno
accepting new patients
Fresno California 93720 United States - Sharp Memorial Hospital
accepting new patients
San Diego California 92123 United States - City of Hope Medical Center, Lenner
accepting new patients
Irvine California 92618 United States - Marin Cancer Care
accepting new patients
Greenbrae California 94904 United States - Stanford University
accepting new patients
Palo Alto California 94304 United States - City of Hope Medical Center, Duarte
accepting new patients
Duarte California 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Protagonist Therapeutics, Inc.
- ID
- NCT05210790
- Phase
- Phase 3 Polycythemia Vera Research Study
- Study Type
- Interventional
- Participants
- Expecting 250 study participants
- Last Updated