An observational study in Polycytemia Vera, sponsored by Federico II University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Federico II University · Observational
This retrospective study aims to evaluate the effectiveness and safety of Ropeginterferon Alfa-2b (BESREMI) in patients with Polycythemia Vera (PV). Eligible patients have a confirmed PV diagnosis according to current criteria, have received at least one dose of Ropeginterferon, and have complete clinical and laboratory data available. The primary objective is to analyze the time course of hematologic response (complete or partial, CHR/PR) according to ELN criteria, and to identify clinical and treatment-related factors associated with achieving and maintaining response. Secondary objectives include time to response, duration of response, progression-free survival, thromboembolic event rate, safety and tolerability, treatment discontinuation, dose modifications and adherence, normalization of hematologic parameters, and changes in JAK2 V617F allele burden. Data will be collected retrospectively from medical records at participating centers.
Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include patients diagnosed with Polycythemia Vera (PV) according to current diagnostic criteria who have received at least one administration of Ropeginterferon Alfa-2b (BESREMI) as part of their disease management. Eligible patients must have complete clinical and laboratory information available and must be followed at one of the participating centers. All participants must provide written informed consent prior to inclusion in the study.
Exclusion Criteria:
Data will be collected retrospectively from patient medical records and will include: 1. Demographic Data 2. Clinical Characteristics of PV 3. Treatment Information. Details on Ropeginterferon Alfa-2b therapy: Dosage; Treatment schedule and duration; Clinical and hematologic response; Treatment discontinuation and reasons for interruption 4. Clinical and Hematologic Response: Hematologic parameters (hemoglobin, hematocrit, platelet count, etc.); Clinical status during treatment; Spleen size assessed via abdominal ultrasound (when available); Documentation of baseline values, prior therapies, dosing schedules, and response assessments at: 3, 6, 9, 12, 18, and 24 months; Discontinuation rates and reasons for stopping therapy 5. Molecular Response: Quantification of JAK2 V617F allele burden over time 6. Adverse Events: Any clinically relevant complications or side effects
Drug: Ropeginterferon alfa-2b (BESREMi®)
Ropeginterferon Alfa-2b was administered in accordance with the approved prescribing information.
Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera
Definition: Proportion of patients achieving Complete Hematologic Response (CHR) or Partial Response (PR) at each scheduled timepoint (3, 6, 9, 12, 18 and 24 months), classified according to the ELN criteria and identification of baseline and on-treatment factors associated with (a) first attainment of CHR/PR and (b) maintenance (duration) of CHR/PR. Assessment timepoints: Baseline, 3, 6, 9, 12, 18 and 24 months (or last available follow-up). Summary metrics: Proportion (%) in CHR and PR at each timepoint
Time frame: From enrollment to the end of treatment or at least 12 months of treatment
Time to Hematologic Response
Time (in months) from the first day of Ropeginterferon Alfa-2b treatment to achievement of CHR or PR hematologic response according to ELN criteria.
Time frame: Baseline to first documented CHR or PR (up to 24 months)
Duration of Hematologic Response
Interval between first documented CHR or PR and loss of that response, death, or last follow-up.
Time frame: From first CHR/PR to loss or last follow-up (up to 24 months)
Progression-Free Survival (PFS)
Time from treatment initiation to progression to post-PV myelofibrosis, acute myeloid leukemia, or death from any cause
Time frame: Baseline to event or last follow-up (up to 24 months)
Thromboembolic Event Rate
Proportion of patients experiencing arterial or venous thrombotic or embolic events during treatment with Ropeginterferon.
Time frame: Baseline to last follow-up (up to 24 months)
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]) CTCAE v6.
Time frame: Baseline to last follow-up (up to 24 months)
Treatment Discontinuation
Proportion of patients who discontinue Ropeginterferon for adverse events, lack of efficacy, or other clinical reasons.
Time frame: Baseline to last follow-up (up to 24 months)
Dose Modifications and Adherence
Number and proportion of patients with significant dose changes (reductions or increases) and estimated adherence (planned vs observed dosing intervals).
Time frame: Baseline to last follow-up (up to 24 months)
Normalization of Hematologic Parameters
Proportion of patients achieving target hematologic values: hematocrit \<45%, leukocytes \<10000/mm³, platelets \<400000/mm³.
Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)
JAK2 V617F Allele Burden
Assessment of JAK2 V617F allele burden dynamics during Ropeginterferon treatment and correlation with hematologic response.
Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)
No study locations are listed for this record.
Plan to share: No — Individual Participant Data (IPD) will not be shared to protect participant privacy and to comply with ethical and regulatory requirements.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Federico II University