Status:
NOT_YET_RECRUITING
Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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 Criteria
Inclusion
- Able and willing to provide a written informed consent
- 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
- 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;
- History of malignant tumors in the past 5 years;
- There are serious concurrent diseases
- Pregnant or lactating women;
- The researchers determined that the subjects had poor compliance or any inappropriate factors for participating in this trial
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT07133815
Start Date
August 1 2025
End Date
December 1 2027
Last Update
August 21 2025
Active Locations (1)
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1
Xiangya Second Hospital of Central South University
Changsha, Hunan, China, 410007