Evaluating symptom burden in patients with Polycythemia Vera treated with ropeginterferon alfa-2b
Official title: Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany
Run by iOMEDICO AG · NCT06743035 · Data updated 2026-11-12
This study is testing how well ropeginterferon alfa-2b helps adults with Polycythemia Vera feel and function better while keeping track of their symptoms and treatment experiences.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Locations | 1 site (Hanover, Lower Saxony) |
| Status | Recruiting |
| Started | December 3, 2024 |
| Main results expected | July 2029 |
| Study ends | July 2029 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT06743035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Polycythemia Vera without symptomatic splenomegaly who are starting treatment with ropeginterferon alfa-2b.
✕Probably not a fit
Patients who have previously received treatment with ropeginterferon alfa-2b or are participating in another interventional clinical trial may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the symptom burden in adult patients diagnosed with Polycythemia Vera (PV) who do not have symptomatic splenomegaly while receiving treatment with ropeginterferon alfa-2b. It will evaluate various patient-relevant endpoints, including the effectiveness of the treatment, complete hematologic response, event-free survival, safety, and tolerability in a real-world setting. The study will also gather information on treatment realities, such as dosing details and factors influencing treatment decisions.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and tolerability of ropeginterferon alfa-2b, potentially improving treatment strategies for patients with PV.
How similar studies have gone: While this study focuses on a specific treatment in a real-world setting, similar studies have shown promise in evaluating treatment effectiveness for myeloproliferative neoplasms.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde
Hanover, Lower Saxony, Germany Recruiting
Study contacts
- Principal investigator: Eyck von der Heyde, Dr. — Onkologische Schwerpunktpraxis
- Study coordinator: Laura Serrer
- Email: rope@iomedico.com
- Phone: +49 761 15242-0
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MPNdpoint: Long-term Look at Philadelphia-negative Myeloproliferative Neoplasms
This study tests how outcomes differ for patients 16 and older with polycythemia vera, essential thrombocythemia, or myelofibrosis by collecting and analyzing clinical and treatment data.
-
Test of bomedemstat for polycythemia vera in adults
This study tests bomedemstat (MK-3543) to see if it helps people with polycythemia vera reach healthier blood counts compared with standard treatments.
-
Rusfertide in Japanese adults with polycythemia vera
This study tests rusfertide in Japanese adults with polycythemia vera to see if it helps keep hematocrit under control and reduce the need for blood removal.
-
Sapablursen added to standard care for people with polycythemia vera
This trial will test whether adding sapablursen to standard therapy can reduce the need for phlebotomy in people with polycythemia vera who remain phlebotomy-dependent.
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MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.
Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.
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ELN multicenter analysis of phenotypic evolution and clinical outcomes
This study tries to find features linked to JAK2V617F-positive essential thrombocythemia (ET) patients who later developed polycythemia vera (PV) by comparing them with matched ET patients who did not progress and with patients diagnosed with de novo PV.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.