Trial · NCT07282132
Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study
NCT07282132, Not yet recruiting, Federico II University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study. Trials, record NCT07282132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07282132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study
- NCT number
- NCT07282132
- Status
- Not yet recruiting
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Federico II University
- Conditions
- Polycytemia Vera
- Interventions
- Ropeginterferon alfa-2b (BESREMi®)
- First posted
- 2025-12-15
- Last updated
- 2025-12-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera | 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 |
| Secondary | Time to Hematologic Response | Baseline to first documented CHR or PR (up to 24 months) | Time (in months) from the first day of Ropeginterferon Alfa-2b treatment to achievement of CHR or PR hematologic response according to ELN criteria. |
| Secondary | Duration of Hematologic Response | From first CHR/PR to loss or last follow-up (up to 24 months) | Interval between first documented CHR or PR and loss of that response, death, or last follow-up. |
| Secondary | Progression-Free Survival (PFS) | Baseline to event or last follow-up (up to 24 months) | Time from treatment initiation to progression to post-PV myelofibrosis, acute myeloid leukemia, or death from any cause |
| Secondary | Thromboembolic Event Rate | Baseline to last follow-up (up to 24 months) | Proportion of patients experiencing arterial or venous thrombotic or embolic events during treatment with Ropeginterferon. |
| Secondary | Incidence of Treatment-Emergent Adverse Events | Baseline to last follow-up (up to 24 months) | Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]) CTCAE v6. |
| Secondary | Treatment Discontinuation | Baseline to last follow-up (up to 24 months) | Proportion of patients who discontinue Ropeginterferon for adverse events, lack of efficacy, or other clinical reasons. |
| Secondary | Dose Modifications and Adherence | Baseline to last follow-up (up to 24 months) | Number and proportion of patients with significant dose changes (reductions or increases) and estimated adherence (planned vs observed dosing intervals). |
| Secondary | Normalization of Hematologic Parameters | Baseline and at scheduled visits (3,6,9,12,18,24 months) | Proportion of patients achieving target hematologic values: hematocrit \<45%, leukocytes \<10000/mm³, platelets \<400000/mm³. |
| Secondary | JAK2 V617F Allele Burden | Baseline and at scheduled visits (3,6,9,12,18,24 months) | Assessment of JAK2 V617F allele burden dynamics during Ropeginterferon treatment and correlation with hematologic response. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07282132
GET https://conductscience.org/api/trials/v1/NCT07282132/registered