Exploration of Biomarkers in Familial Hypercholesterolemia (FH)
Research type
Research Study
Full title
Exploration of Biomarkers in Familial hypercholesterolemia (FH)
IRAS ID
306965
Contact name
Handrean Soran
Contact email
Sponsor organisation
Beren Therapeutics, P.B.C.
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
This study is designed for patients with Familial Hypercholesterolemia (FH).
During the study the patient will have a blood sample (55 mL) taken one time. The Investigator will collect information about patient age, sex, ethnicity, health, medical history including the history of hypercholesterolemia and treatments that patient has received, and he/she is currently receiving. Patient's medical records will be reviewed once each year for two years after patient visit. If the study staff does not have complete records, they may need to call the patient for this information.
It is anticipated that up to 150 patients will be enrolled in the study. Following enrollment of approximately 50 patients, an interim analysis will be conducted, and the result will determine final target number of patients, not to exceed 150.
Subject participation is expected to be approximately 2 years in the study. During that period they will have one Visit on Screening and one visit on Day 1 (Screening and Day 1 assessments may be performed on the same day). Approximately one-, one and a half-, and two- year(s) post Day 1, a retrospective chart review from the previous visit will be conducted to record Major Adverse Cardiac and Cerebrovascular Events (MACCE). Medications taken for cardiovascular disease will also be recorded in the CRF. This information may be obtained via a phone call to the patient if medical records are not available at the study site.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
21/WM/0292
Date of REC Opinion
17 Jan 2022
REC opinion
Further Information Favourable Opinion