Safely Quenching Complement in Stroke Survivors

Sponsor
Columbia University
Study ID
NCT07495722
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Pegcetacoplan Injection [Empaveli] — DRUG
    In this study, participants will receive three 1,080 mg doses delivered within 0-3 hours following endovascular thrombectomy, and at 24 and 48 hours after the initial dose. Pegcetacoplan is FDA-approved for the treatment of paroxysmal nocturnal hemoglobinuria and is being evaluated in this study for its safety and tolerability in acute ischemic stroke patients following reperfusion.

Study Details

This study will include adults (ages 18-80) who have had a stroke caused by a large blood clot blocking blood flow in the brain. All patients in the study must have already had a treatment called a thrombectomy, where doctors remove the clot to help blood flow return to the brain. The goal of this study is to test the safety of a drug called EMPAVELI (pegcetacoplan). This drug is meant to lower swelling and inflammation that can happen after blood flow returns. The hope is that it may help protect the brain from more damage and improve recovery. People in the study will get three doses of EMPAVELI through an EMPAVELI-designed pump 0-3 hours post thrombectomy surgery and 24 and 48 hours after the initial dose. Doctors will check them with exams, blood tests, brain scans, and other tests while they are there. Patients will also have follow-up visits at 30 and 90 days to see how they are doing, per the usual standard of care. This research is important because, even with current stroke treatments, many patients still have problems like disability. If this drug is found to be safe, it could lead to better treatments to protect the brain and help people recover more fully after a stroke.

Key Dates

Start date
Oct 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Empaveli (Pegcetacoplan) Treatment
    Participants will receive pegcetacoplan (Empaveli) administered as three subcutaneous doses of 1,080 mg given within 0-3 hours following endovascular thrombectomy, and at 24 and 48 hours after the initial dose. This is a single-arm, open-label study designed to evaluate the safety and tolerability of complement C3 inhibition in adults with acute ischemic stroke due to anterior circulation large vessel occlusion.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through 90 days post-treatment ]

Central Contacts

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