RecruitingNot Applicable

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

Germany200 participantsStarted 2024-12-03

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Symptom Burden

Timeframe: From Time of enrollment until month 36.

Trial details

NCT IDNCT06743035

SponsoriOMEDICO AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-07

Contact for this trial

Laura Serrer

+49 761 15242-0 rope@iomedico.com