A multicenter, single arm, open label phase II clinical study evaluating the long-term efficacy and safety of SHR-1918 in homozygous familial hypercholesterolemia patients
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Subjects who received and completed the SHR-1918-301 study treatment in previous studies and were deemed to have therapeutic benefits by the researchers
Exclusion Criteria:
1. Known to be allergic to the investigational drug or any component of the investigational drug, or to have experienced severe allergic reactions to other antibody drugs;
2. History of malignant tumors in the past 5 years;
3. There are serious concurrent diseases
4. Pregnant or lactating women;
5. The researchers determined that the subjects had poor compliance or any inappropriate factors for participating in this trial
Primary outcome measure(s)
The incidence and severity of adverse events — during the study period About 48 months，
Trial sites (1)
Facility
City
Region
Status
Xiangya Second Hospital of Central South University
Changsha
Hunan
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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