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

iOMEDICO

Status: Enrolling

Conditions: Polycythemia Vera

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06743035

IOM-060513

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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