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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Symptom Burden — From Time of enrollment until month 36. Absolute values of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total symptom score (TSS) at time of study enrollment, during course of study until month 36.
Trial sites (1)
Facility
City
Region
Status
Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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