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Joint Clinical Trials Office

An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects with Polycythemia Vera

Clinical Trial Details

The purpose of this study is to determine whether the study drug, Rusfertide, is safe and effective for treating Polycythemia Vera for those that require routine phlebotomies (removal of red blood cells) to control their disease.

Participants in this study should have previously participated in a study in which Rusfertide (also known as PTG-300) was being studied. Participants will continue to receive Rusfertide in this study.

Rusfertide is an experimental study drug that lowers the level of iron in the blood. Iron is required for production of red blood cells. Rusfertide has been tested for safety and efficacy in small clinical studies in patients with Polycythemia Vera, a blood disorder called beta-thalassemia, and in a disorder of iron metabolism called hemochromatosis. Rusfertide is an experimental study drug because it has not been approved by the United States Food and Drug Administration (FDA).
   
Participation in this study will last up to about 2 years and include 13 study visits to the study clinic.

Key Eligibility: 

Inclusion Criteria:

  1. Participants who have completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 or Phase 3 study of rusfertide.

Exclusion Criteria:

  1. Participants who discontinued early from a previous rusfertide study for reasons other than enrolling in this study.
  2. Pregnant or lactating females.
  3. Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception during the study and for 30 days after the last dose of the study drug

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Mendez
212-746-4829
vib9049@med.cornell.edu

Primary Investigator(s)

Ellen K. Ritchie, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2402027111

ClinicalTrials.gov:

NCT06033586

Sponsor:

PTG-300-21

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • Protagonist Therapeutics

Disease

Myeloproliferative Neoplasms
Polycythemia Vera