Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759534
Status:
UNKNOWN
Last Update Posted:
2021-08-25
First Post:
2021-02-10
Brief Title:
Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia
Sponsor:
Shenzhen Peoples Hospital
Organization:
Shenzhen Peoples Hospital
Study Overview
Official Title:
Phase III Clinical Study to Evaluate the Efficacy and Safety of PCSK9 Inhibitors in the Prevention of Chinese Heterozygous Familial Hypercholesterolemia
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study plans to enroll several patients with heterozygous familial hypercholesterolemia randomly assigned to different dose groups and randomly receiving subcutaneous injection of IBI306150 mg or placebo every two weeks or subcutaneous injection of IBI306 450mg every four weeks n49 or placebo n25 treatment treatment lasted for 12 weeks During randomization the LDL-C level 48mmolL or 48mmolL observed during the screening period visit VI and whether ezetimibe was used for stratification After 12 weeks each group entered the 12-week open-period treatment in which subjects in the IBI306 group continued to receive IBI306 treatment and subjects in the placebo group stopped using placebo and received IBI306 treatment The exploratory endpoint is the population pharmacokinetic characteristics of IBI306 in Chinese heterozygous familial hypercholesterolemia population
Detailed Description:
This study plans to enroll 148 patients with heterozygous familial hypercholesterolemia and maintain a low-fat diet and stably take the current anterior-lowering therapy for at least 4 weeks Randomly enter different dose groups at 11 2 1 randomized to receive subcutaneous injection of IBI306150 mg n49 or placebo n25 every two weeks or subcutaneous injection of IBI306 450mg n49 or placebo n25 every four weeks The treatment lasted 12 weeks During randomization the LDL-C level 48mmolL or 48mmolL observed during the screening period visit VI and whether ezetimibe was used for stratification After 12 weeks each group entered the 12-week open-period treatment in which subjects in the IBI306 group continued to receive IBI306 treatment and subjects in the placebo group stopped using placebo and received IBI306 treatment The primary endpoint was the percentage change in LDL-C levels from baseline at 12 weeks The secondary endpoints were the changes in blood lipid levels from baseline at 12 and 24 weeks drug safety and immunogenicity The exploratory endpoint is the population pharmacokinetic characteristics of IBI306 in Chinese heterozygous familial hypercholesterolemia population If necessary the dose of IBI306 will be adjusted according to the results of the ongoing multi-dose climbing study After the open period the subjects will undergo an 8-week safety visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None