Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-1918

    Drug

    SHR-1918

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: SHR-1918Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence and severity of adverse events

Time frame
during the study period About 48 months,

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: