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

Condition(s) studied

Investigational drug(s) / intervention(s)

P1101 (Ropeginterferon alfa-2b): The subjects who have completed the 52-week treatment duration in Study A19-201 will be treated with P1101, starting at the dose at Week 50. The dose during this study may be increased or decreased up to 500 μg depending on the condition. This study will be continued as a post-marketing clinical study after acquisition of the marketing approval of P1101.

Study 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.

Eligibility

Primary outcome measure(s)

• Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks — Through study completion, an average of 2 year
  CHR will be defined as follows. * Hematocrit \<45% phlebotomy-free (absence of phlebotomy during the previous 12 weeks) * Platelet count ≤ 400 x 10\^9/L * WBC count ≤ 10 x 10\^9/L

Trial sites (6)