Status:
COMPLETED
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.
Detailed Description
This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate ...
Eligibility Criteria
Inclusion
- Males and females ≥ 18 to ≤ 80 years of age
- Diagnosis of homozygous familial hypercholesterolemia
- LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
- Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
- Bodyweight of ≥ 40 kg at screening
Exclusion
- History of liver transplant
- Uncontrolled hypertension
- Moderate to severe renal dysfunction
- Active liver disease or hepatic dysfunction
- Known sensitivity to any of the products to be administered during dosing
Key Trial Info
Start Date :
September 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04031742
Start Date
September 29 2019
End Date
December 30 2021
Last Update
August 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China