An observational study in Polycythemia Vera, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational
This is a multicentric, observational, retro-prospective study in adult PV patients - resistant or intolerant to hydroxyurea - who are going to receive or have already initiated treatment with ruxolitinib according to the approved local label. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.
This is a multicentric, observational, retro-prospective study in adult population who have been diagnosed with polycythemia vera according to the 2022 (WHO or ICC) criteria, who are resistant or intolerant to hydroxyurea and who are going to be prescribed or have already initiated treatment with ruxolitinib according to the approved local label. Patients who started treatment with ruxolitinib - according to clinical practice - will be enrolled. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's planned enrollment of 153 is below the median of 240 across 44 observational studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 135 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of Polycythemia vera according to WHO or ICC 2022 criteria who received treatment with ruxolitinib as second-line therapy for resistance / intolerance to hydroxyurea, according to the prescription criteria approved in Italy. Patients already on treatment (retrospective part) at the start date of the study and patients included after the start date for a period of 9 months may be included in the study
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
effectiveness of ruxolitinib
Proportion of patients who reach the target hct \<45% within 3 months in the absence of phlebotomy
Time frame: at 3 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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