NCT02222714

Safety Evaluation of 3K3A-APC in Ischemic Stroke

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: ZZ Biotech, LLC · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment with tPA, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke. Approximately 115 subjects were to be randomized, which included the planned 88 subjects in groups of 4 subjects to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who were enrolled during safety review pauses. This study used a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD). Eligible subjects received 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurred first. Subjects were monitored for safety evaluations through Day 7 (or discharge, if earlier) and were expected to be seen on Day 7, 14, 30, and 90 for safety and outcome evaluations.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
BIOLOGICAL	3K3A-APC	3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
DRUG	Placebo	Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-04-18
• Completion: 2017-06-29
• First posted: 2014-08-21
• Last updated: 2018-11-08
• Results posted: 2018-11-08

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study