Status:
UNKNOWN
A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hyperchole...
Eligibility Criteria
Inclusion
- Males and females ≥ 18 years of age
- Diagnosis of homozygous familial hypercholesterolemia
- Stable lipid-lowering therapies for at least 28 days
- LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
- Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
- Bodyweight of ≥ 40 kg at screening.
Exclusion
- LDL or plasma apheresis within 8 weeks prior to randomization
- New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months of randomization, Planned cardiac surgery or revascularization, Uncontrolled cardiac arrhythmia
- Liver transplant history.
- Uncontrolled hypertension.
- Moderate to severe renal dysfunction.
- Active liver disease or hepatic dysfunction.
- Known sensitivity to any of the products to be administered during dosing
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04455581
Start Date
September 1 2020
End Date
August 31 2021
Last Update
July 2 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.