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क्लिनिकल ट्रायल NCT07495722 (SUCCESS) के लिए तीव्र इस्केमिक स्ट्रोक, सेरेब्रल इन्फार्क्शन वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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Safely Quenching Complement in Stroke Survivors (SUCCESS) चरण I 20

अभी भर्ती शुरू नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07495722 (SUCCESS) का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन तीव्र इस्केमिक स्ट्रोक, सेरेब्रल इन्फार्क्शन से जुड़ा हुआ है और यह एक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 20 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 अप्रैल 2026 से शुरू होगा। कोलंबिया विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 अगस्त 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 27 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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 inflamma...

और दिखाएँ
विस्तृत विवरण
Acute ischemic stroke (AIS) remains the primary cause of disability worldwide. Advances in revascularization therapies such as pharmacologic thrombolysis and intra-arterial endovascular thrombectomy (EVT) have improved outcomes, yet >50% of patients remain functionally disabled at 90 days post-ictus onset despite high recanalization rates. One major reason for this limited recovery is the activation of thrombo-infla...और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
तीव्र इस्केमिक स्ट्रोकसेरेब्रल इन्फार्क्शन
अन्य अध्ययन आईडी
  • SUCCESS
  • SUCCESS-01
NCT नंबर
NCT07495722
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-04
अंतिम अद्यतन प्रकाशित
2026-03-27
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-08
नामांकन (अनुमानित)
20
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
endovascular thrombectomy
large vessel occlusion
reperfusion injury
complement inhibition
C3 inhibition
pegcetacoplan
empaveli
neuroprotection
thromboinflammation
stroke recovery
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकEmpaveli (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.
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.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Incidence of Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of pegcetacoplan (Empaveli) in adult patients with acute ischemic stroke following endovascular thrombectomy, as measured by the incidence, type, and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs).
Through 90 days post-treatment
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Neurological Functional Outcome
Functional outcome as measured by the modified Rankin Scale (mRS). The scale is from 0-6, where 0 indicates no symptoms at all and 6 indicates Death. Therefore, higher scores represent worse outcomes.
Through 90 days post-treatment
Neurological Deficit Severity
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline. The scale is graded from 0-42, with a score of 0 indicating no stroke while a maximum score of 42 indicates severe stroke. A higher score represents greater stroke severity.
Baseline through 90 days
Biomarker Response
Changes in complement and neuroinjury biomarkers (e.g., C3, C3b, S100b, GFAP)
Baseline through 90 days
Maximum Plasma Concentration [Cmax] of Pegcetacoplan
Maximum observed plasma concentration (Cmax) of pegcetacoplan following administration.
Through 72 hours
Time to Maximum Plasma Concentration [Tmax] of Pegcetacoplan
Time to reach maximum observed plasma concentration (Tmax) of pegcetacoplan.
Through 72 hours.
Infectious Complications
Incidence of infections including sepsis, pneumonia, and urinary tract infections
During hospitalization and through 90 days
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  • 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.

  • 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
Columbia University logoकोलंबिया विश्वविद्यालय808 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिए
अध्ययन उत्तरदायी पक्ष
E. Sander Connolly, मुख्य अन्वेषक, Chair and Professor, Department of Neurological Surgery, Columbia University
अध्ययन केंद्रीय संपर्क
संपर्क: Angela Velazquez, 6465151909, [email protected]
संपर्क: Eleonora F Spinazzi, MD, [email protected]
कोई स्थान डेटा नहीं।