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Engagement Study for Participants With Factor V Leiden and Prothrombin G20210A Mutations

Recruitingn/aAges 18 Years - anyAllRichmond Research Institute
NCT07584265 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will enrol individuals who have, or may have, Factor V Leiden or Prothrombin G20210A mutations, which are genetic changes linked to an increased risk of blood clots. Targeted genetic testing will be carried out, where appropriate, to confirm whether participants have one of these genetic variants. Those with a confirmed result will attend a site visit for basic health checks, including blood pressure measurements, ECG, and blood tests, to establish a baseline of their general health and help identify suitability for future related clinical trials. The study also provides participants with the opportunity to learn more about clinical research and become familiar with the clinical trial unit and team. Participation lasts approximately 10 weeks and includes 1-2 site visits and a follow-up telephone call.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male or female participants aged ≥ 18 years at the date of signing the Participant Information Sheet/Informed Consent Form (PIS/ICF). 2. Ability to provide written, personally signed, and dated informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines E6 (R3) (2025) and applicable regulations, before any study-specific procedures are performed. 3. Confirmed or suspected diagnosis of FVL or Prothrombin G20210A mutation via targeted genetic testing. Exclusion Criteria: 1. Unwilling or unable to comply with the protocol-defined study assessments. 2. Any other significant disease or disorder that, in the opinion of the Principal Investigator (PI) or Sponsor, may either place the participant at risk from participation, or influence the clinical baseline.
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What it tests

  • Not listed
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Where

1 site
Richmond Pharmacology Limited
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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