Clinical Trial 21756

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT05210790

Phase: Phase III
Principal Investigator: Kuykendall, Andrew

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera

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.

Objective

To evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera in maintaining hematocrit control.

Treatments

Therapies

Therapy (NOS)

Medications

Placebo (); Rusfertide (PTG-300)

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 and have either JAK2 V617F mutation or JAK2 exon 12 mutation.

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 as listed in protocol

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.

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 non-invasive non-melanomatous (e.g., squamous cell or basal cell carcinoma) skin cancer during screening unless adequately treated before randomization.

Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

Clinical Trials Search

Advanced Search