Homozygous Familial Hypercholesterolemia
Conditions
Brief summary
A multicenter, single arm, open label phase II clinical study evaluating the long-term efficacy and safety of SHR-1918 in homozygous familial hypercholesterolemia patients
Interventions
DRUGSHR-1918
SHR-1918
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects who received and completed the SHR-1918-301 study treatment in previous studies and were deemed to have therapeutic benefits by the researchers
Exclusion criteria
1. Known to be allergic to the investigational drug or any component of the investigational drug, or to have experienced severe allergic reactions to other antibody drugs; 2. History of malignant tumors in the past 5 years; 3. There are serious concurrent diseases 4. Pregnant or lactating women; 5. The researchers determined that the subjects had poor compliance or any inappropriate factors for participating in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | during the study period About 48 months， |
Countries
China
Contacts
Primary ContactMeng Sun
Backup ContactChao Lyu
Outcome results
None listed