Clinical trial Recruiting at 1 site Observational Ages 18 and up

Engagement study for people with Factor V Leiden and Prothrombin G20210A mutations

Official title: Engagement Study to Establish a Clinical Baseline for Adult Participants With Factor V Leiden or Prothrombin G20210A Mutation and Familiarise Them With the Clinical Trials Unit Environment for Future Clinical Trial Participation.

Run by Richmond Pharmacology Limited · NCT07584265 · Data updated 2026-11-12

This study tests how to connect with adults who have or may have Factor V Leiden or Prothrombin G20210A mutations and introduces them to clinical trials.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorRichmond Pharmacology Limited
Industry-sponsored
Locations1 site (London)
StatusRecruiting
StartedApril 21, 2026
Main results expectedJanuary 31, 2027
Study endsJanuary 31, 2027
Registry record updatedMay 29, 2026
Trial IDNCT07584265 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with confirmed or suspected Factor V Leiden or Prothrombin G20210A mutations who can consent and comply with study procedures.

Probably not a fit

Participants who do not have the mutations or who do not complete the visits may receive no direct medical benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study recruits adults with or suspected to have Factor V Leiden or Prothrombin G20210A mutations. Targeted genetic testing is used to confirm the mutation status. Participants undergo basic health assessments at a site visit to establish a health baseline, including blood pressure, ECG, and laboratory tests. The study lasts about 10 weeks and includes 1–2 site visits plus a follow-up phone call, with the goal of helping participants learn about clinical research and identify eligibility for future related trials.

Why it matters

Potential benefit: Participants may gain access to genetic confirmation and an introduction to ongoing clinical research opportunities.

How similar studies have gone: Previous studies have used similar engagement approaches to connect patients with mutation-related trials, with variable success in informing eligibility.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Richmond Pharmacology Limited
    London, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.