Status:
COMPLETED
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Primary Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.
Eligibility Criteria
Inclusion
- Any male or female aged between 18 and 80 on the date of signing the informed consent;
- Diagnosed as hypercholesterolemia ;
- Fasting triglyceride was less than 5.6 mmol/L during screening:
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Exclusion
- A history of the following diseases or treatments during the screening period:
- Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
- Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);
- Any of the laboratory test indicators meets the following criteria:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;
- The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
- Have used the following drugs:
- PCSK9 inhibitors had been used in the previous 6 months;
- Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
- Other circumstances:
- Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose
- Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04844125
Start Date
April 14 2021
End Date
August 12 2022
Last Update
April 25 2023
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou, China, 510080