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Taking people in GermanyNo phase

Observes ropeginterferon treatment in adults with polycythemia vera

Follows adults with polycythemia vera without enlarged spleen symptoms during ropeginterferon treatment.

Plain-language title generated from the registry record
Registry title: Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

Key facts

Where
Hanover, GermanySee the site

Where in Germany

  • Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der HeydeHanover, GermanyTaking people

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Trial details

Who runs it
iOMEDICO AG
Trial code
NCT06743035
Record updated
9 January 2026
Original description
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.Read full original descriptionShow less

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

ClinicalTrials.gov NCT06743035