Evaluating symptom burden in patients with Polycythemia Vera treated with ropeginterferon alfa-2b
Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany
iOMEDICO AG · NCT06743035
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG (industry) |
| Locations | 1 site (Hanover, Lower Saxony) |
| Trial ID | NCT06743035 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hanover, Lower Saxony
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Polycythemia Vera, Ropeginterferon alfa-2b, polycythemia vera, symptom burden, myeloproliferative neoplasm