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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Richmond Pharmacology Limited Industry-sponsored |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | April 21, 2026 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07584265 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
- Study coordinator: James Rickard, MPharm
- Email: jrickard@richmondresearchinstitute.org
- Phone: +44 (0) 20 7042 5800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Single-dose test of CITY-FXI in adults with and without Factor V Leiden or Prothrombin G20210A mutation
This will test a single dose of CITY-FXI, an siRNA that lowers Factor XI, in healthy adults and in adults who carry Factor V Leiden or the prothrombin G20210A mutation to see if it is safe and how it acts in the body.
-
Chronic Respiratory Disease Participant Engagement
This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.
-
Collecting ECG data and patient insights on heart failure care
This study is collecting heart monitoring data and patient feedback from people with heart failure to help improve future heart disease research and treatments.
-
Preventing hospital admission for ATTR cardiomyopathy with home telemonitoring
This will test whether a home telemonitoring service using daily weight scales can reduce hospital admissions for adults with ATTR cardiac amyloidosis.
-
Non-invasive tool to predict fatty liver disease
This study is testing a new, non-invasive tool to see if it can help identify fatty liver disease in healthy people and those already diagnosed with it.
-
COVID-19 antibody and PCR testing program
This project uses PCR and blood antibody tests to find current or past COVID-19 infection in people aged 5 to 70, including those with and without symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.