NCT06743035 Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly
| NCT ID | NCT06743035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iOMEDICO AG |
| Condition | Polycythemia Vera |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-12-03 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Eyck von der Heyde, Dr.
PRINCIPAL INVESTIGATOR
Onkologische Schwerpunktpraxis
Frequently Asked Questions
Who can join the NCT06743035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Polycythemia Vera. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06743035 currently recruiting?
Yes, NCT06743035 is actively recruiting participants. Contact the research team at rope@iomedico.com for enrollment information.
Where is the NCT06743035 trial being conducted?
This trial is being conducted at Hanover, Germany.
Who is sponsoring the NCT06743035 clinical trial?
NCT06743035 is sponsored by iOMEDICO AG. The principal investigator is Eyck von der Heyde, Dr. at Onkologische Schwerpunktpraxis. The trial plans to enroll 200 participants.