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Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke

NCT05484154 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-10-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC, a recombinant variant of human activated protein C (APC), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.

Conditions

Interventions

BIOLOGICAL

3K3A-APC

3K3A-APC, diluted in 0.9% sodium chloride in water, given at 100 mL IV infusion

OTHER

Placebo

Matching placebo, 0.9% sodium chloride in water, given at 100 mL IV infusion

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Southern California

    collaborator OTHER

  • University of Cincinnati

    collaborator OTHER

  • University of South Carolina

    collaborator OTHER

  • ZZ Biotech, LLC

    lead INDUSTRY

Principal Investigators

  • Patrick D Lyden, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-07-31
Completion
2026-10-31
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484154 on ClinicalTrials.gov