Phase 3 trial of D-PLEX in post-cardiac surgery sternal infection.

Trial Profile

Phase 3 trial of D-PLEX in post-cardiac surgery sternal infection.

Planning
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2017

At a glance

  • Drugs Doxycycline (Primary)
  • Indications Postoperative infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 16 Aug 2017 According to a PolyPid media release, company plans to initiate this study in 2018.
    • 16 Mar 2017 New trial record
    • 09 Mar 2017 According to a PolyPid media release, Company recently completed a successful pre-Investigational New Drug Application meeting with the FDA in which the Agency agreed that D-PLEX™ can move directly into a Phase III trial in the U.S., based on the satisfactory results from Phase Ib/II trial (CTP 700282729)
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