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Trial Title:
Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice
NCT ID:
NCT05566535
Condition:
Polycythemia Vera
Conditions: Official terms:
Polycythemia Vera
Polycythemia
Conditions: Keywords:
ruxolitinib
quality of life
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Ruxolitinib
Description:
Ruxo will be administered to patients with PV in a real-world setting. Treatment with
Ruxo is according to local approved label. Ruxo treatment should be administered
according to drug official instruction and in compliance with clinical practice at the
certain medical center.
Summary:
The purpose of this multicenter observational prospective cohort study is to examine
changes in QoL and symptoms in patients with polycythemia vera (PV) during treatment with
ruxolitinib (Ruxo), and to evaluate efficacy and safety of Ruxo in a real-world setting
Criteria for eligibility:
Study pop:
Adult patients with PV will be enrolled after being prescribed with Ruxo. The eligibility
criteria for this study are broader than those for patients to be treated with Ruxo in
randomized clinical trials, so as to be reflective of routine clinical practice
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients who have confirmed diagnosis of PV
- Patients whose age - 18 years and older
- Patients who signed informed consent
- Patients who able to fill out questionnaires
Exclusion Criteria:
- Patients enrolled in clinical trials
- Patients with contraindications to Ruxo in accordance with instruction for use
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2022
Completion date:
August 1, 2024
Lead sponsor:
Agency:
Multinational Center for Quality of Life Research, Russia
Agency class:
Other
Source:
Multinational Center for Quality of Life Research, Russia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566535
