Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

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:
  • 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 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

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