A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
SHR-1918
Homozygous Familial Hypercholesterolemia+9
+ Hyperlipoproteinemia Type II
+ Hyperlipidemias
Treatment Study
Summary
Study start date: December 22, 2023
Actual date on which the first participant was enrolled.This clinical study focuses on testing a drug called SHR-1918 to see how effective it is in lowering "bad" cholesterol, also known as low-density lipoprotein cholesterol (LDL-C), in people who have homozygous familial hypercholesterolemia (HoFH). HoFH is a rare genetic condition where individuals inherit a tendency for high cholesterol levels from both parents, which can lead to serious heart problems. This study is important because it aims to find a better treatment for lowering LDL-C in these patients, potentially reducing their risk of heart disease and improving their quality of life. In this study, participants with HoFH will receive the drug SHR-1918. The study is open-label, meaning both the researchers and participants will know they are receiving this specific treatment, and it is single-arm, meaning all participants receive the same treatment without a comparison group. The main focus is to measure how much the levels of LDL-C decrease, helping researchers understand the drug's effectiveness. While the study does not list specific risks or benefits, participants will be closely monitored to ensure their safety and to observe the drug's effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The Second Xiangya Hospital of Central South University Hospital
Changsha, ChinaOpen The Second Xiangya Hospital of Central South University Hospital in Google Maps