Polycythemia VeraNCT07868081
A Study to Better Understand the Diagnosis and Treatment of Polycythaemia Vera
An observational study of Polycythemia Vera, run by Takeda.
Trial summary
PV is a rare, long-term blood cancer that causes the body to make too many blood cells. This can make the blood thicker than normal and the risk of blood clots higher. People with PV often experience symptoms that can affect their daily lives. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polycythemia Vera
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Licensed hematologists and hemato-oncologists who are board-certified or independently practicing and actively involved in diagnosing or managing patients with PV will be enrolled.
Who may be able to join
- Board-certified or practicing hematology specialists actively managing PV patients.
- Currently practicing in a hospital or clinic setting in the Kingdom of Saudi Arabia or Ukraine or Türkiye.
- Minimum of 3 years of experience in the management of myeloproliferative neoplasms and/or hematological malignancies. Actively managing a minimum number of PV patients, defined as either:
- Has managed at least 10 patients with PV during the past 3 to 5 years, or at least 3 to 5 patients with PV during the past 12 months.
- Willing and able to provide informed consent and participate in a standardized survey and vignette assessment in a language in which the approved study materials are available, including English, Turkish, or Ukrainian, as applicable to the participating country.
Who cannot join
- Physicians not currently involved in the diagnosis or management of PV patients.
- Medical trainees, residents, or fellows not yet board-certified or independently practicing.
- Practicing outside of KSA or Ukraine or Türkiye.
- Unwilling or unable to provide informed consent or complete the study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Knowledge, Attitudes and Practices Through Unified Real-world Experimental Vignettes in Polycythemia Vera (PV): KAPTURE-PV, a Multi-Country Vignette-Based Observational Study
PV is a rare, long-term blood cancer that causes the body to make too many blood cells. This can make the blood thicker than normal and the risk of blood clots higher. People with PV often experience symptoms that can affect their daily lives. Understanding how doctors diagnose and treat PV in everyday medical practice in a certain country can help find the differences in knowledge, diagnosis, and treatment of PV across countries.
This study will not review or collect data from actual people with PV. It will collect information on the diagnosis and treatment of PV using a standard set of questions on and examples of fictional (unreal) people with PV. This is called clinical vignette. The study will ask doctors from several countries to complete this survey.
Read more
The main aim of this study is to better understand how well doctors know about and diagnose PV and how they treat PV in certain countries.
Other aims are to better understand how PV is managed and treated in everyday medical practice across countries. This includes which treatment people with PV receive once they are diagnosed and how access to medicines and healthcare services and other factors affects a doctor's treatment decisions for PV.
Read the detailed description
This study is a non-interventional, cross-sectional physician survey study employing a Knowledge, Attitudes and Practices (KAP) framework and standardized Polycythemia Vera clinical vignettes. Data are collected through a single interviewer-led session with practicing hematologists and hemato-oncologists. The study evaluates physician diagnostic and treatment decision-making patterns and does not involve patient enrollment, patient-level data collection, treatment assignment, or longitudinal follow-up.
- Conditions
- Polycythemia Vera
- Being tested
- No Intervention
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Physician Survey | Eligible hematologists and hemato-oncologists will participate in a single survey session lasting approximately 30 minutes. The session will use standardized PV clinical vignettes and a combination of open and closed-ended questions to assess physicians' KAP and clinical decision making. All data will be collected through audio-recorded interviews (where applicable) and/or typed narrative entries in a secure online platform. No clinical intervention will be administered, and no follow-up will be conducted. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participating Physicians Correctly Identifying the Prespecified Diagnostic Criteria and Risk-Classification Factors for PV in Standardized Clinical Vignettes
For each prespecified diagnostic criterion and risk-classification factor, the percentage of participating physicians selecting the protocol-defined correct response will be reported.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Distribution of Physician Responses Regarding Early Cytoreductive Treatment in PV
The number of participating physicians selecting each response category for the statement 'Early cytoreductive therapy is underutilized in PV management in my region' will be reported using a 5-point Likert agreement scale ranging from 1, 'Strongly disagree,' to 5, 'Strongly agree.' Higher scores indicate greater agreement with the statement. Treatment choices made in the standardized PV clinical vignettes will also be summarized descriptively.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Concordance of Physician-Reported Diagnostic and Treatment Decisions With Prespecified PV Guideline-Based Criteria
For each applicable survey or vignette decision, the number of participating physicians whose response is concordant with the protocol-defined guideline-based criterion will be reported.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Distribution of Self-Reported Rate of Adherence to International Guidelines in Diagnostic and Therapeutic Decisions
For each guideline category, the number of participating physicians reporting 'Always,' 'Often,' or 'Rarely' will be summarized. The international guideline most commonly used will also be reported.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Distribution of Physician-Reported Phlebotomy Use and Cytoreductive Treatment in Current PV Management
The distribution of the estimated percentage of physicians' patients currently managed with phlebotomy alone, phlebotomy plus cytoreductive therapy, ruxolitinib, or other therapies will be summarized.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Number of Physicians by Reported HCT Monitoring Frequencies and HCT Thresholds for Treatment Escalation
HCT monitoring intervals will be summarized separately for low- and high-risk PV. Physician-reported HCT thresholds for treatment escalation will be summarized descriptively.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Secondary outcomes (4)
Percentage of Physicians Reporting Use of Diagnostic Procedures and Treatment Modalities Used for PV Management
The percentage of participating physicians reporting use of each prespecified diagnostic procedure and treatment modality, including phlebotomy, aspirin, cytoreductive treatment, and individual treatment agents, will be reported. For each prespecified diagnostic or monitoring tool, the number and percentage of physicians reporting 'Always,' 'Often,' or 'Rarely' will be reported separately for initial diagnosis and ongoing monitoring.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Percentage of Physicians Reporting Factors Influencing Clinical Decision-Making in PV Management
The percentage of participating physicians selecting each prespecified factor, including physician experience, resource limitations, patient characteristics, treatment preferences, and access-related considerations, as most important in their decision to change PV treatment will be reported.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Percentage of Physicians Selecting Each Treatment-Management Option in low- and High-Risk PV Clinical Vignettes
Percentage of physicians selecting each prespecified classification and treatment-management option in response to low- and high-risk PV clinical vignettes will be reported. Responses will be descriptively aggregated to summarize commonly reported sequences of treatment without ranking treatment sequences, identifying an optimal sequence, or making causal inferences.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Percentage of Physicians Reporting Systemic Barriers to Optimal PV Care and Their Perceived Impact
For each prespecified barrier to early cytoreductive therapy, the percentage of physicians rating its impact as high, moderate, or low will be reported. The barriers selected among the top three barriers to optimal PV care will be summarized separately.
Measured: At completion of the approximately 30-minute survey session (up to 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868081
- Sponsor's protocol ID
- TAK-121-5004
- Other IDs
- MACS-2026-020602
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.