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

Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany

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.

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