drugset / Trial / NCT04655092

Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

NCT04655092

Phase 3 Recruiting 67 enrolled PharmaEssentia Japan K.K.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.

Timeline

Start
2021-01-19
Primary completion
2026-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 250 ug Subcutaneous
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 500 ug Subcutaneous