Ischemic Stroke Clinical Trial
Official title:
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
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.
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.
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