Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06506084 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 9, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Active, Not Recruiting → Recruiting
    • Enrollment increased: 319 → 429 participants
    • Study completion pushed from Dec 31, 2026 to Dec 31, 2029
    • Study sites revised (37)
    v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 37 of 37 sites
    v6
  3. Study sites: 32 to 37v5
  4. Primary completion date: Sep 30, 2024 to Sep 30, 2026v4
  5. Re-verified, no change to tracked fieldsv3
  6. Secondary endpoints revised (7)v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Polycythaemia vera (PV) is associated with a reduced quality of life, a high rate of vascular events, and an intrinsic risk of disease evolution. The results of several randomised trials for the treatment with new cytoreductive agents are now available, among which a new ropegylated formulation of interferon alfa-2b (ropeginterferon alfa-2b) have been recently approved in Europe and USA \[EMA (2019), FDA (2021) and AIFA (2022)\]. The use of this drug in clinical practice is an opportunity for a prospective observational study in a rare disease such as PV; the aim is to evaluate its impact in the practical management of these patients. Therefore, the main objectives of the present study are to determine: (i) to what extent ropeginterferon alfa-2b can be prescribed and tolerated in patients with PV; (ii) the risk-benefit of ropeginterferon alfa-2b in patients with PV, followed-up in real-world clinical practice.
Trial Details
NCT Number NCT06506084
Lead Sponsor FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Conditions
(from sponsor)		 Polycythemia Vera
Related terms Polycythemia Vera
Enrollment 429 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov