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

Last updated: September 26, 2024
Sponsor: ZZ Biotech, LLC
Overall Status: Trial Not Available

Phase

3

Condition

Stroke

Thrombosis

Blood Clots

Treatment

3K3A-APC

Placebo

Clinical Study ID

NCT05484154
ZZ-3K3A-301
UG3NS119199
  • Ages 18-90
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Acute ischemic stroke

  • Able to receive thrombolysis, mechanical thrombectomy or both

  • National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5

  • Signed informed consent

  • Agreement to use effective birth control throughout the study

Exclusion

Exclusion Criteria:

  • Neurologic deficit is non-disabling

  • History of stroke or penetrating head injury within 90 days prior to enrollment

  • History of previous or current diagnosis of intracranial hemorrhage

  • Moyamoya disease, cerebral arteriovenous malformation, or known unsecured aneurysmrequiring intervention during the acute study period

  • Presence of tandem lesions suggesting a likely need for proximal artery stentingduring the thrombectomy procedure that would mandate post-operative dualantiplatelet therapy

  • Presence of other neurological or non-neurological co-morbidities, independently ofthe current stroke, that may lead to further deterioration in the subject'sneurological status during the study period

  • Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)

  • Severe hypertension or hypotension

  • Blood glucose concentration < 50 mg/dL

  • Prior exposure to any exogenous form of a recombinant variant of human APC

Study Design

Treatment Group(s): 2
Primary Treatment: 3K3A-APC
Phase: 3
Study Start date:
October 01, 2024
Estimated Completion Date:
October 31, 2026

Study Description

This multicenter, randomized, placebo-controlled, double-blind, Phase 3 study is being performed in coordination with StrokeNet to evaluate efficacy and safety of 3K3A-APC following administration of thrombolysis, mechanical thrombectomy, or both in subjects with moderate to severe acute ischemic stroke.

The study will be conducted in two phases. During a lead-in dose-finding phase, a maximum of 360 subjects will be randomized to 3K3A-APC or placebo using a Bayesian adaptive approach. Randomized subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days) or until discharge from the hospital (whichever occurs first). The lead-in phase will transition to one selected 3K3A APC dose-and recruitment will continue-when a single dose proves superior to all other doses and safe.

The definitive phase will continue with the selected dose of 3K3A-APC from the lead-in phase. Randomization will be stratified on 4 variables. Lead-in patients who received the dose selected for the definitive phase will be included in the final data analysis.