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 startedstudy ends 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, Counterfeit Drugs, 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:
- 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.
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
La Jolla 5363943 California 5332921 92037 United States - University of California, Los Angeles (UCLA) - Medical Center
Los Angeles 5368361 California 5332921 90095 United States - University of California, San Francisco
San Francisco 5391959 California 5332921 94117 United States - California Cancer Associates for Research and Excellence - Fresno
Fresno 5350937 California 5332921 93720 United States - Sharp Memorial Hospital
San Diego 5391811 California 5332921 92123 United States - City of Hope Medical Center, Lenner
Irvine 5359777 California 5332921 92618 United States - Marin Cancer Care
Greenbrae 5354013 California 5332921 94904 United States - Stanford University
Palo Alto 5380748 California 5332921 94304 United States - City of Hope Medical Center, Duarte
Duarte 5344147 California 5332921 91010 United States
Details
- Status
- in progress, not 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
- About 293 people participating
- Last Updated