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Clinical Trial 20102

Cancer Type: Malignant Hematology
Interventions:PTG-300 (); Placebo ()

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Andrew Kuykendall

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients with Phlebotomy-Requiring Polycythemia Vera

Summary

This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera.

Objective

1. Obtain a preliminary estimate of PTG-300s efficacy in phlebotomy-requiring polycythemia vera (PCV) subjects including changes in phlebotomy requirement and splenomegaly. 2. Assess the safety of PTG-300 in PCV subjects who are phlebotomy requiring.

Inclusion Criteria

  • All participants must meet ALL of the following inclusion criteria
  • 18 years or older
  • Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera
  • Receiving aspirin therapy for polycythemia vera (subjects for whom aspirin is not contraindicated)
  • Records of all phlebotomies performed for at least 24 weeks before screening are available
  • Participants who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events due to cytoreductive therapy
  • Subjects receiving cytoreductive therapy with hydroxyurea, interferon, or ruxolitinib must be on a stable dose for at least 24 weeks before screening and with no planned change in dose

  • Exclusion Criteria

  • Participants must meet NONE of the following exclusion criteria
  • Active or chronic bleeding within 4 weeks of screening
  • Meets the criteria for post-PCV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
  • Known primary or secondary immunodeficiency
  • Any surgical procedure requiring general anesthesia within 1 month prior to screening or planned elective surgery during the study