Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Symptom Burden
- timeFrame
- From Time of enrollment until month 36.
- description
- Absolute values of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total symptom score (TSS) at time of study enrollment, during course of study until month 36.
Secondary outcomes (15)
- measure
- Effectiveness: Complete hematologic response (CHR) rate
- timeFrame
- From time of treatment start until end of study (max. 54 months after FPI)
- description
- CHR rate is defined as the proportion of patients with * Hematocrit (HCT) \<45% and * Phlebotomy-free (absence of phlebotomy during the previous 3 months) and * Platelet count ≤400 x 10\^9/L and * white blood cell count ≤10 x 10\^9/L
- measure
- Effectiveness: Event-free survival (EFS)
- timeFrame
- From time of treatment start until end of study (max. 54 months after FPI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available