Heterozygous Familial Hypercholesterolemia
Conditions
Interventions
LD Group:EPI-003 I.V
MD Group:EPI-003 I.V
HD Group:EPI-003 I.V
extension group:EPI-003 I.V
OBD
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Refractory adult subjects with a confirmed diagnosis of HeFH and adequate treatment; and 2 Patients eligible for enrollment in the following. Stage I: patients with LDL-C levels =3.8 mmol/L (146.7 mg/dL) and TG =4.5 mmol/L (400 mg/dL); Phase II: patients without ASCVD with LDL-C levels =3.8 mmol/L (146.7 mg/dL) and TG =4.5 mmol/L (400 mg/dL). Stage II: LDL-C level =2.6 mmol/L (100 mg/dL) and TG = 4.5 mmol/L (400 mg/dL) in patients with uncomplicated ASCVD; or LDL-C level =1.8 mmol/L (70 mg/dL) and TG = 4.5 mmol/L (400 mg/dL) in patients with complicated ASCVD.
Exclusion criteria
Exclusion criteria: 1 Subjects with confirmed diagnosis of HoFH; and 2 Subjects diagnosed with any uncontrolled serious disease such as heart failure, uncontrolled diabetes, severe hypertension, chronic hepatitis, etc.; and 3 Subjects who have undergone organ transplantation, gene therapy. 4 Pregnant or breastfeeding women; and 5 Subjects with abnormal cardiovascular, hepatic, or renal function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE/SAE;Injection site reactions;Laboratory tests (blood count, blood biochemistry, urine count, coagulation function, etc.);CRP;cytokine level;Physical Examination;12-lead ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum PCSK9 concentration;blood lipid;PK parameters;Immunogenicity of EPI-001 Injection; | — |
Countries
China
Contacts
Public ContactJun Xie
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed