Polycytemia VeraMIRRORNCT07282132
Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study
An observational study of Polycytemia Vera, run by Federico II University.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polycytemia Vera
- What is being tested?
- Ropeginterferon alfa-2b (BESREMi®)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Confirmed diagnosis of Polycythemia Vera according to updated diagnostic criteria
- Have received at least one dose of Ropeginterferon Alfa-2b (BESREMI).
- Complete clinical and laboratory data availability for review (e.g., hematologic parameters, treatment response, adverse events).
- Followed at one of the participating study centers.
- Have signed informed consent for participation.
Who cannot join
- Have received experimental or non-approved treatments for PV during the observation period.
- Lack sufficient clinical or laboratory data to allow inclusion in the analysis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter Insights on Real-World Results Of Ropeginterferon Alpha-2B in Polycythemia Vera Patients
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.
- Conditions
- Polycytemia Vera
- Being tested
- Ropeginterferon alfa-2b (BESREMi®)
- Keywords
- Ropeginterferon alpha 2b
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropeginterferon alfa-2b (BESREMi®)Drug
Ropeginterferon Alfa-2b was administered in accordance with the approved prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Polycythemia Vera Receiving Ropeginterferon aplha 2b | 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 Receives: Drug: Ropeginterferon alfa-2b (BESREMi®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment or at least 12 months of treatment
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and at scheduled visits (3,6,9,12,18,24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion26 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycytemia VeraStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Novella Pugliese, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282132
- Sponsor's protocol ID
- AIFA-RSO-3948
- Other IDs
- AIFA-RSO-3948
- Acronym
- MIRROR
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared to protect participant privacy and to comply with ethical and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Insights on Real-World Results Of Ropeginterferon Alpha-2B in Polycythemia Vera Patients
- ClinicalTrials.gov ID
- NCT07282132
- Acronym / sponsor ID
- MIRROR / AIFA-RSO-3948
- Conditions
- Polycytemia Vera
- Keywords
- Ropeginterferon alpha 2b
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Polycythemia Vera Receiving Ropeginterferon aplha 2b | – | Drug: Ropeginterferon alfa-2b (BESREMi®)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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Polycythemia Vera according to updated diagnostic criteria
- Have received at least one dose of Ropeginterferon Alfa-2b (BESREMI).
- Complete clinical and laboratory data availability for review (e.g., hematologic parameters, treatment response, adverse events).
- Followed at one of the participating study centers.
- Have signed informed consent for participation.
Key exclusion criteria (2 listed)
- Have received experimental or non-approved treatments for PV during the observation period.
- Lack sufficient clinical or laboratory data to allow inclusion in the analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropeginterferon alfa-2b (BESREMi®)Ropeginterferon Alfa-2b was administered in accordance with the approved prescribing information. | Drug | Patients with Polycythemia Vera Receiving Ropeginterferon aplha 2b |
Primary outcome
Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera
Time frame: From enrollment to the end of treatment or at least 12 months of treatment
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
9 secondary outcomes
Time to Hematologic Response
Time frame: Baseline to first documented CHR or PR (up to 24 months)
Duration of Hematologic Response
Time frame: From first CHR/PR to loss or last follow-up (up to 24 months)
Progression-Free Survival (PFS)
Time frame: Baseline to event or last follow-up (up to 24 months)
Thromboembolic Event Rate
Time frame: Baseline to last follow-up (up to 24 months)
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to last follow-up (up to 24 months)
Treatment Discontinuation
Time frame: Baseline to last follow-up (up to 24 months)
Dose Modifications and Adherence
Time frame: Baseline to last follow-up (up to 24 months)
Normalization of Hematologic Parameters
Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)
JAK2 V617F Allele Burden
Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared to protect participant privacy and to comply with ethical and regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycytemia Vera, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novella Pugliese, MD, PhD (+393396137232, novypugliese@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera (time frame: From enrollment to the end of treatment or at least 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.