A Multi-Center, Randomized, Placebo Controlled, Double-Blind Study to Confirm Efficacy and Safety of Terlipressin in Subjects With Hepatorenal Syndrome Type 1 (The CONFIRM Study)

Trial Profile

A Multi-Center, Randomized, Placebo Controlled, Double-Blind Study to Confirm Efficacy and Safety of Terlipressin in Subjects With Hepatorenal Syndrome Type 1 (The CONFIRM Study)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Sep 2017

At a glance

  • Drugs Terlipressin (Primary)
  • Indications Hepatorenal syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms CONFIRM
  • Sponsors Mallinckrodt Inc.
  • Most Recent Events

    • 22 Sep 2017 Planned End Date changed from 1 Jan 2020 to 1 Nov 2019.
    • 22 Sep 2017 Planned primary completion date changed from 1 Jan 2020 to 1 Nov 2019.
    • 13 Jul 2017 According to a Mallinckrodt plc media release, the company has enrolled the 75th subject in this trial and has achieved one quarter of its targeted enrollment. Additionally, an important interim analysis of trial data to assess the safety and efficacy of terlipressin in study subjects will be completed when 150 subjects are enrolled. The interim analysis has been approved under the Special Protocol Assessment agreed upon with the US FDA.
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