{"entity":{"id":"nct06093672","kind":"trial","name":"Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera","aka":[],"tldr":"A phase 3 trial testing Givinostat in myeloproliferative neoplasms, now recruiting.","summary":"Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera is a phase 3 interventional study registered as NCT06093672, led by Italfarmaco with PPD Development, LP, and recruiting on the registry. Official title: Randomised, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL. Planned enrolment is 220 participants (estimated). The study started in 2024-03-26 and primary completion is expected in 2026-07. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06093672","url":"https://clinicaltrials.gov/study/NCT06093672"}],"tags":["ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","polycythaemia-vera"],"sections":[],"technologies":[],"targets":[],"drugs":["givinostat"],"companies":["italfarmaco"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06093672","phase":"3","setting":"Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL","sponsor":"Italfarmaco","started":"2024-03-26","startedType":"actual","enrolled":220,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06093672/","neighbours":{"cancer":[{"id":"myeloproliferative-neoplasms","kind":"cancer","name":"Myeloproliferative neoplasms (PV, ET, myelofibrosis)","route":"/cancers/myeloproliferative-neoplasms/"},{"id":"polycythaemia-vera","kind":"cancer","name":"Polycythaemia vera (PV)","route":"/cancers/polycythaemia-vera/"}],"drug":[{"id":"givinostat","kind":"drug","name":"Givinostat","route":"/drugs/givinostat/"}],"company":[{"id":"italfarmaco","kind":"company","name":"Italfarmaco","route":"/companies/italfarmaco/"}]}}