NCT07584265 Engagement Study for Participants With Factor V Leiden and Prothrombin G20210A Mutations
| NCT ID | NCT07584265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Richmond Research Institute |
| Condition | Factor V Leiden |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-04-21 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07584265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Factor V Leiden. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07584265 currently recruiting?
Yes, NCT07584265 is actively recruiting participants. Contact the research team at jrickard@richmondresearchinstitute.org for enrollment information.
Where is the NCT07584265 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07584265 clinical trial?
NCT07584265 is sponsored by Richmond Research Institute. The trial plans to enroll 100 participants.