Not Yet RecruitingPhase 2

Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

China55 participantsStarted 2025-08

Plain-language 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

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

The incidence and severity of adverse events

Timeframe: during the study period About 48 months，

Trial details

NCT IDNCT07133815

SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Meng Sun

+86 18036618718 meng.sun@hengrui.com

View on ClinicalTrials.gov More Homozygous Familial Hypercholesterolemia trials