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Recruiting NCT06743035

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

— Observational Polycythemia Vera

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Polycythemia Vera. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany

Overview

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.

Primary outcome measures

  • Symptom Burden [Time frame: From Time of enrollment until month 36.]
Secondary outcome measures (12)
  • Effectiveness: Complete hematologic response (CHR) rate [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]
  • Effectiveness: Event-free survival (EFS) [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]
  • Effectiveness: Proportion of patients with platelet count ≤400 ×109/L [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]
  • Effectiveness: Proportion of patients with WBC count <10 ×109/L [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]
  • Effectiveness: Proportion of patients with HCT value <45% [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]
  • Effectiveness: Proportion of patients without phlebotomy during course of study [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]
  • Drug safety [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]
  • Dosing [Time frame: From start until end of treatment (max. 54 months after FPI)]
  • Treatment discontinuation [Time frame: From start until end of treatment (max. 54 months after FPI)]
  • (S)ADRs leading to permanent treatment discontinuation [Time frame: From start until end of treatment (max. 54 months after FPI)]
  • Symptom burden [Time frame: From time of enrollment until month 36 after treatment start (max. 54 months after FPI)]
  • Treatment reality: previous cytoreductive therapies [Time frame: From time of treatment start until end of study (max. 54 months after FPI)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde — Hanover

Identifiers

NCT: NCT06743035 · IOM-060513

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗