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

Not Applicable

Not yet recruiting

• Conditions: Homozygous Familial Hypercholesterolemia
• Interventions: Drug: SHR-1918

• Registration Number: NCT07133815
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2025-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1918	SHR-1918	-

Primary Outcome Measures

Name	Time	Method
The incidence and severity of adverse events	during the study period About 48 months，

Trial Locations

Locations (1)

Xiangya Second Hospital of Central South University; 🇨🇳 Changsha, Hunan, China