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Exploration of Biomarkers in Familial Hypercholesterolemia (FH)

Exploration of Biomarkers in Familial Hypercholesterolemia (FH) - FH-001

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51891
Enrollment
25
Registered
2021-12-08
Start date
2021-12-23
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hereditary high cholesterol

Interventions

One blood sample will be collected on Day 1 (55 ml).

Sponsors

Beren Therapeutics P.B.C.
Lead Sponsor

Eligibility

Age
12 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patients clinically diagnosed using regional diagnostic criteria (e.g., Simon Broome, Dutch Lipid Network, MEDPED, etc.) and/or genetically confirmed diagnosis of Familial Hypercholesterolemia (FH) 2. >=12 years of age 3. Triglycerides =190mg/dL within last 30 days for untreated adults o >=150mg/dL within last 30 days for untreated children OR o >=160mg/dL within last 30 days for stably treated patients (adults & children)

Exclusion criteria

Exclusion criteria: 1. Conditions or circumstances that, in the opinion of the Investigator, could interfere with or confound study results, or preclude informed consent. 2. Liver transplant recipients. 3. Patients who have undergone partial ileal bypass surgery. 4. Patients with evidence in medical history of chronic HBV infection, HCV infection, or HIV infection 5.Patients who are currently participating or have participated in a clinical trial in which investigational intervention was administered within 12 weeks or 5 half-lives, whichever is longer, of Screening in this clinical study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)