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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 hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.
Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subcutaneous injection of JS002, 450mg, Q4W, 3/13 times. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS002 | Drug | Biological: JS002 Administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of effectiveness | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital Capital Medical University | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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