A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
NCT ID: NCT04031742
Last Updated: 2023-08-09
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/PHASE3
18 participants
INTERVENTIONAL
2019-09-29
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1: IBI306
Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks.
IBI306
Administered by subcutaneous injection
Part 2: IBI306
Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks.
IBI306
Administered by subcutaneous injection
Interventions
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IBI306
Administered by subcutaneous injection
IBI306
Administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of homozygous familial hypercholesterolemia
3. LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
4. Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
5. Bodyweight of ≥ 40 kg at screening
Exclusion Criteria
2. Uncontrolled hypertension
3. Moderate to severe renal dysfunction
4. Active liver disease or hepatic dysfunction
5. Known sensitivity to any of the products to be administered during dosing
18 Years
80 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, , China
Countries
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Other Identifiers
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CIBI306A201
Identifier Type: -
Identifier Source: org_study_id
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