To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
NCT ID: NCT04515927
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2020-08-17
2022-07-29
Brief Summary
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Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.
JS002
Biological: JS002 Administered by subcutaneous injection
Interventions
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JS002
Biological: JS002 Administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. Age ≥12 and ≤75 years old;
3. Weight ≥40kg at the time of screening
4. Patients diagnosed with HoFH
5. Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
6. Fasting triglycerides ≤4.5 mmol/L;
Exclusion Criteria
2. History of uncontrolled arrhythmia within 3 months
3. History of MI,UA, PCI or CABG, stroke within 3 months.
4. History of DVT or pulmonary embolism within 3 months.
5. Planned cardiac surgery or revascularization.
6. Uncontrolled hypertension.
7. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
8. Other conditions that the researchers considered inappropriate to participate in the study.
12 Years
75 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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JS002-004
Identifier Type: -
Identifier Source: org_study_id
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