Phase 3, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (REVERSE Trial)

Trial Profile

Phase 3, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (REVERSE Trial)

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2017

At a glance

  • Drugs Terlipressin (Primary)
  • Indications Hepatorenal syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms REVERSE
  • Sponsors Ikaria
  • Most Recent Events

    • 29 Mar 2017 Results of pooled anlaysis of two phase III studies (REVERSE and OT-0401) published in the Alimentary Pharmacology and Therapeutics
    • 16 Nov 2016 Post-hoc analysis results published in a Mallinckrodt plc media release.
    • 16 Feb 2016 Primary endpoint has not been met (Confirmed Hepatorenal syndrome reversal) as reported by results published in the Gastroenterology
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