Safety Evaluation of 3K3A-APC in Ischemic Stroke "RHAPSODY"


Phase 2 Results N/A

Summary of Purpose

The purpose of this study is 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.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 9 January 2018.

1 Oct 2014 18 Aug 2014 1 Jul 2017 1 Oct 2017 1 Jan 2018 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment