Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

Last updated: December 19, 2024
Sponsor: iOMEDICO AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia (Pediatric)

Bone Marrow Disorder

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT06743035
IOM-060513
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age ≥18 years

  • Confirmed diagnosis of PV without symptomatic splenomegaly

  • Indication and decision for treatment with ropeginterferon alfa-2b in accordancewith current SmPC

  • No prior treatment with ropeginterferon alfa-2b (Patients are allowed to be enrolledup to 6 weeks after their first dose of ropeginterferon alfa-2b but must still be ontreatment at the time of enrollment.)

  • Dated signature of informed consent form

  • Participation in Patient-Reported Outcome (PRO) assessment in German language andcompletion of questionnaire at time of study enrollment

  • Other criteria according to current Summary of Product Characteristics

Exclusion

Exclusion Criteria:

  • Participation in an interventional clinical trial (except follow-up)

  • Other contraindications according to current Summary of Product Characteristics

Study Design

Total Participants: 200
Study Start date:
December 03, 2024
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde

    Hannover, Niedersachsen 30161
    Germany

    Active - Recruiting

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