A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population

Trial Profile

A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population

Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Fibrinogen/thrombin (Primary) ; Gelatin
  • Indications Surgical blood loss
  • Focus Therapeutic Use
  • Sponsors Mallinckrodt Inc.; ProFibrix; The Medicines Company
  • Most Recent Events

    • 13 Jul 2017 Planned End Date changed from 1 Aug 2018 to 1 Sep 2018.
    • 13 Jul 2017 Planned primary completion date changed from 1 Jul 2018 to 1 Sep 2018.
    • 28 Sep 2016 Planned number of patients changed from 108 to 87.
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