Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly
ConditionPolycythemia Vera
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG
About this trial
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
Qualifiers
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.)
Disqualifiers
Participation in an interventional clinical trial (except follow-up)
Other contraindications according to current Summary of Product Characteristics
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
iOMEDICO AG
Lead sponsor
AOP Orphan Pharmaceuticals Germany GmbH
Collaborator
Source ClinicalTrials.gov