Engagement Study for Participants With Factor V Leiden and Prothrombin G20210A Mutations
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRichmond Research Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
Male or female participants aged ≥ 18 years at the date of signing the Participant Information Sheet/Informed Consent Form (PIS/ICF).
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.
Confirmed or suspected diagnosis of FVL or Prothrombin G20210A mutation via targeted genetic testing.
Disqualifiers
Unwilling or unable to comply with the protocol-defined study assessments.
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.
Trial population
Adult participants with known or suspected FVL or Prothrombin G20210A mutation
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Willingness to be re-contacted for future clinical trials and Feedback Questionnaire.
Study duration: Up to 15 weeks
Time frame
Until the end of the study (up to 15 weeks)Secondary outcomes
1
Genotype and zygosity status
Proportion of participants with confirmed Factor V Leiden or Prothrombin G20210A mutation, including zygosity (heterozygous or homozygous), based on targeted genetic testing.
Time frame
Screening2
Prior venous thromboembolism (VTE) phenotype
Descriptive summary of participant history of venous thromboembolism, including type (e.g., deep vein thrombosis, pulmonary embolism), age at first event, and provoking factors, collected via medical history.
Time frame
Day 13
Anticoagulation status
Current and prior use of anticoagulant therapy, including type and indication, as recorded in medical history and concomitant medications.
Time frame
Day 14
Haematology parameters
Descriptive summary of haematology parameters obtained from blood samples as specified in the protocol
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov