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NOT YET RECRUITING

NCT07495722

PHASE1

Safely Quenching Complement in Stroke Survivors

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

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.

Official title: Safely Quenching Complement in Stroke Subjects: A Phase 1 Safety Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2027-08

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Acute Ischemic Stroke Cerebral Infarction

Interventions

DRUG

Pegcetacoplan Injection [Empaveli]

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.

Inclusion Criteria: * Adults (18-80 years old) * Diagnosis of AIS due to anterior circulation (Intracranial ICA, M1 MCA) LVO with evidence of complete/near-complete revascularization following EVT (mTICI ≥2b). * Enrollment within 24 hours of reperfusion, with reperfusion occurring within 24 hours of ictus onset. * Body weight ≥ 50 kg. * Absolute reticulocyte count \>1.0 x ULN * Platelet count of \>50,000/mm³ * Absolute neutrophil count (ANC) ≥ 1500/mm³ at * Vaccination against Neisseria meningitidis types A, C, W, Y and B, Streptococcus pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day1 dosing, or within 14 days after EMPAVELI. Unless documented evidence exists, that subjects are non-responders to vaccination as evidenced by titers or display titer levels within acceptable local limits * Women of child-bearing potential (WOCBP) must have a negative pregnancy test and must agree to use protocol defined methods of contraception for the duration of the study and 90 days after study drug administration. * Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and 90 days after study drug administration. * English/Spanish-speaking patients or legally authorized representatives (LARs). * Signed informed consent from the patient or LAR. Exclusion Criteria: * Pregnant or lactating female * Suspected pregnancy. * Renal insufficiency (GFR\<30mL/minute OR creatinine \>2 mg/dL OR need for renal replacement therapy (RRT) at time of admission). * Platelet count \< 50,000/mm³ * Absolute neutrophil count \<1500/mm³ * Baseline mRS \>2 * Presence of concomitant serious illness that would confound study, including but not limited to serious psychiatric or autoimmune disease, sepsis, or trauma. * Immunocompromised status (e.g., subjects with Human Immunodeficiency Virus \[HIV\] infection, neutropenia, complement deficiency, etc.) * Autoimmune disorder (Sjogren's Disease, Psoriasis, hediak-Higashi Syndrome) * Presence of any intracranial bleed (ICH, SAH, SDH, hemorrhagic lesion). * Active hepatic failure as defined by AST \>160 units/L and/or ALT \>180 units/L, or total bilirubin levels greater than four times normal levels (\>4.8mg/dL). * Continued use of digoxin or amlodipine (as recommended by the manufacturer due to CYP3A inhibition). * Patients with DNR orders. * Known infection at the time of admission (elevated WBC with identified infection source) * Evidence of blood dyscrasia. * Episode of fever \> 38.5 degrees Celsius during admission and prior to enrollment. * History of any clinically significant disease or disorder which, in the opinion of the Investigator, could have either put the subject at risk because of participation in the study, or interfered with interpretation of the subject's study results