Clinical trial · Observational
LOW-PV Continuation
- 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)
This multicenter longitudinal observational study focuses on Italian patients with Polycythemia Vera (PV) who were enrolled in the Low-PV RCT and continued receiving Ropeginterferon alfa-2b until the study's conclusion on March 31, 2023. It includes patients who were responders to Ropeginterferon alfa-2b after two years in the phase II randomized trial "LOW-PV." Data will be collected retrospectively every 6 months from March 31, 2023 to November 30, 2024 and prospectively from December 1, 2024 to March 31, 2026.
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
- Maintenance of Treatment response
- timeFrame
- From date of randomization until the date of follow up assessed up to 6 months.
- description
- Median HCT lower than 45% without disease progression
Secondary outcomes (7)
- measure
- Complete hematological (CHR) and clinical remission (CR)
- timeFrame
- From date of randomization until the date of follow up assessed up to 6 months
- description
- Rate of Efficacy
- measure
- Change in JAK2 variant allele frequency (VAF) since treatment start
- timeFrame
- From date of randomization until the date of follow up assessed up to 6 months
- description
- Rate of Efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients enrolled in the LOW-PV RCT study who continued to receive Ropeginterferon alfa-2b until the conclusion of the study on March 31, 2023. These patients will be included regardless of the treatment they are undergoing at the time of enrollment in the current study. * Patients who have signed the written informed consent for study participation. Exclusion Criteria: * None
References
Publications (0)
Data not yet available