A Phase 3 interventional study of 3K3A-APC and Placebo in Ischemic Stroke, sponsored by ZZ Biotech, LLC. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by ZZ Biotech, LLC · Phase 3, Interventional, and Treatment
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.
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
Browse Ischemic Stroke studies →ZZ Biotech, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
3K3A-APC, q12h for up to 5 doses
Biological: 3K3A-APC
3K3A-APC, q12h for up to 5 doses
Biological: 3K3A-APC
3K3A-APC, q12h for up to 5 doses
Biological: 3K3A-APC
Matching placebo, q12h for up to 5 doses
Other: Placebo
3K3A-APC, diluted in 0.9% sodium chloride in water, given at 100 mL IV infusion
Also known as: 3K3A-Activated Protein C
Matching placebo, 0.9% sodium chloride in water, given at 100 mL IV infusion
Also known as: Matching Placebo
To evaluate the effect of 3K3A-APC on 90-day disability
Day 90 mRS scores will be compared between groups using ordinal (shift) analysis
Time frame: Day 90 mRS
To evaluate the safety of 3K3A-APC
The percentage of subjects who experienced any treatment-related AE will be compared using a Fisher's exact test.
Time frame: Baseline to Day 90
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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