Exploration of Biomarkers in Familial Hypercholesterolemia (FH)
- Conditions
- hereditary high cholesterol10027424
- Registration Number
- NL-OMON51891
- Lead Sponsor
- Beren Therapeutics P.B.C.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
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 <= 300 mg/dL
4. Average Fasting LDL-C levels:
o >=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)
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>N/A</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>