NCT06743035Recruiting
Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly
Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 16 Dec 2024
- Start date
- 3 Dec 2024
- Primary completion date
- Jul 2029
- Lead sponsor
- iOMEDICO AG
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT06743035
What you commit to
- Study type: Observational
- Planned participants: 200
- From 3 Dec 2024 to the primary completion date, Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participation in an interventional clinical trial (except follow-up)
- Other contraindications according to current Summary of Product Characteristics
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.