Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly
Recruiting now
Conditions studied: Polycythemia Vera
In brief
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.
Key facts
- Study ID
- NCT06743035
- Run by
- iOMEDICO AG
- People needed
- 200
- Starts
- 2024-12-03
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2026-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Participation in an interventional clinical trial (except follow-up)
- Other contraindications according to current Summary of Product Characteristics
Where it is running
- Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde — Hanover, Lower Saxony, Germany (enrolling)
Full record on ClinicalTrials.gov
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