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

Beijing Suncadia Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Homozygous Familial Hypercholesterolemia

Treatments: Drug: SHR-1918

Study type: Interventional

Funder types: Industry

Identifiers

NCT07133815

SHR-1918-205

Details and patient eligibility

About

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

Enrollment: 55 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

SHR-1918

Experimental group

Treatment:

Drug: SHR-1918