NCT05481151

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: PharmaEssentia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV

Detailed description

Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML) Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV. This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	P1101 (Ropeginterferon alfa-2b-njft)	Ropeginterferon alfa-2b-njft
DRUG	Ropeginterferon alfa-2b-njft (P1101)	Ropeginterferon alfa-2b-njft

Timeline

• Start date: 2022-10-26
• Primary completion: 2025-06-30
• Completion: 2027-07-31
• First posted: 2022-08-01
• Last updated: 2025-08-13

Locations

23 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study