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Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

Recruiting
18 years and older
All
Phase N/A

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Overview

The primary objective of this non interventional study is to evaluate symptom burden in adult patients with PV without symptomatic splenomegaly during treatment with ropeginterferon alfa-2b in a real-world setting. Further patient-relevant endpoints include effectiveness including complete hematologic response (CHR), event-free survival (EFS), safety and tolerability, treatment reality including dosing details as well as factors affecting treatment decision making.

Eligibility

Inclusion Criteria:

  • Age ≥18 years
  • Confirmed diagnosis of PV without symptomatic splenomegaly
  • Indication and decision for treatment with ropeginterferon alfa-2b in accordance with current SmPC
  • No prior treatment with ropeginterferon alfa-2b (Patients are allowed to be enrolled up to 6 weeks after their first dose of ropeginterferon alfa-2b but must still be on treatment at the time of enrollment.)
  • Dated signature of informed consent form
  • Participation in Patient-Reported Outcome (PRO) assessment in German language and completion of questionnaire at time of study enrollment
  • Other criteria according to current Summary of Product Characteristics

Exclusion Criteria:

  • Participation in an interventional clinical trial (except follow-up)
  • Other contraindications according to current Summary of Product Characteristics

Study details
    Polycythemia Vera

NCT06743035

iOMEDICO AG

15 October 2025

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