Status:
COMPLETED
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Hyperlipemia
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hyperchol...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Age ≥12 and ≤75 years old;
- Weight ≥40kg at the time of screening
- Patients diagnosed with HoFH
- Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
- Fasting triglycerides ≤4.5 mmol/L;
Exclusion
- History of NYHA class III-IV heart failure or EF\<30%
- History of uncontrolled arrhythmia within 3 months
- History of MI,UA, PCI or CABG, stroke within 3 months.
- History of DVT or pulmonary embolism within 3 months.
- Planned cardiac surgery or revascularization.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
- Other conditions that the researchers considered inappropriate to participate in the study.
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04515927
Start Date
August 17 2020
End Date
July 29 2022
Last Update
July 24 2024
Active Locations (1)
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1
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, China