Not yet recruiting NCT07133815
Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1918.
- Who it may be relevant to
- Registry conditions: Homozygous Familial Hypercholesterolemia. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug SHR-1918
SHR-1918
Primary outcome measures
- The incidence and severity of adverse events [Time frame: during the study period About 48 months，]
Eligibility criteria
Inclusion criteria
- Able and willing to provide a written informed consent
- 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
- 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;
- History of malignant tumors in the past 5 years;
- There are serious concurrent diseases
- Pregnant or lactating women;
- The researchers determined that the subjects had poor compliance or any inappropriate factors for participating in this trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiangya Second Hospital of Central South University — Changsha
Identifiers
NCT: NCT07133815 · SHR-1918-205