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A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 14 Oct 2021

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At a glance

  • Drugs Drotrecogin alfa (Primary)
  • Indications Embolism and thrombosis; Septic shock; Systemic inflammatory response syndrome
  • Focus Therapeutic Use
  • Acronyms PROWESS-SHOCK
  • Sponsors Eli Lilly and Company; Eli Lilly and Company (India) Pvt. Ltd
  • Most Recent Events

    • 14 Oct 2021 This trial has been completed in France (End Date: 26 Feb 2012), according to European Clinical Trials Database record.
    • 09 Mar 2012 Planned number of patients changed from 1500 to 1696 as reported by ClinicalTrials.gov.
    • 25 Oct 2011 Status changed from recruiting to discontinued, according to an Eli Lilly media release. The PROWESS-SHOCK trial was discontinued as it failed to meet its primary endpoint. In addition, the drug is being withdrawn from all markets.
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