CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
3K3A-APC +1 morebiological
Likely dose
3K3A-APC 100 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02222714
NCT02222714Phase 2Completed
CompareCT.gov

A Multi-center, Phase 2 Study Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC in Combination With tPA, Mechanical Thrombectomy or Both in Moderate to Severe Acute Ischemic Stroke

ZZ Biotech, LLC·interventional·Posted Aug 21, 2014·Updated Nov 8, 2018

In Brief

A Phase 2 clinical trial evaluating 3K3A-APC and Placebo for Ischemic Stroke. Completed, enrolled 110 participants across 15 sites.

Detailed Summary

The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), Cedars-Sinai Medical Center, Massachusetts General Hospital, University of Iowa

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 21, 2014
Enrollment StartOct 1, 2014
Primary CompletionApr 18, 2017
Study CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.9 years ago

Interventions

3K3A-APCbiological

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

Placebodrug

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