A Phase IIIb, Single-Arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Polycythemia Vera (PV)

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have Polycythemia (PV). Ropeginterferon alfa-2b-njft is an investigational drug that has been approved by the US FDA to treat PV, and the goal of Ropeginterferon alfa-2b-njft is to normalize blood counts, reduce the risk of blood clotting and bleeding, and to slow disease progression. The approved dosing for Ropeginterferon alfa-2b-njft requires a starting dose of 100 mcg and will increase 50mcg every 2 weeks. The purpose of this study is to look at the effectiveness, safety, and tolerability of long-term therapy on this drug using an optimized dosing scheme of 250-350-500 mcg. The dose of 500 mcg should be achieved at Week 4, following the treatment start.

If you are enrolled into this study, you will be treated with injections of varying dose levels of Ropeginterferon alfa-2b-njft. You are expected to be in this research study for up to 96 Weeks plus another 28 days for safety follow-up, but this will depend on how you respond to the study drug and what the Study Doctor thinks is in your best interest.

Study-related (insert exams, tests and experimental medication) provided free of charge.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05481151