Phase 2 Evaluation of Weekly Rusfertide Injections in Japanese Adults with Polycythemia Vera to Control Hematocrit and Reduce Phlebotomy

What this Trial Is About

Polycythemia vera PV is a rare blood cancer where the body produces too many red blood cells, causing thicker blood and raising the risk of serious problems like blood clots. This study aims to see if rusfertide can help Japanese adults with PV keep their hematocrit levels under control and reduce the need for regular blood removal procedures called phlebotomies. The study is a phase 2, open-label trial, meaning both participants and researchers know the treatment being given. Participants will receive rusfertide injections under the skin once a week for an initial 52-week period, followed by a long-term extension period of 182 weeks where treatment continues. After the treatment phases, there is a 4-week safety follow-up to monitor participants. All participants receive rusfertide, and no placebo or comparator group is involved. During the study, participants will have regular hematology tests to monitor their blood levels and hematocrit control. Researchers will track the number of phlebotomies needed and measure the percentage of participants maintaining hematocrit below 45%. Follow-up visits and assessments will continue for up to about 244 weeks, including screening, treatment, extension, and safety follow-up to evaluate the treatments impact and safety.

A Study of Rusfertide in Japanese Adults With Polycythemia Vera