NCT02770716

Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1. Out of every three participants, two will receive terlipressin and one will receive placebo. Assignments will be made randomly.

Detailed description

The primary objective of this trial is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.

Conditions

• Hepatorenal Syndrome

Interventions

Type	Name	Description
DRUG	Terlipressin	Terlipressin solution for injection
OTHER	Placebo	Matching placebo solution for injection

Timeline

• Start date: 2016-07-13
• Primary completion: 2019-07-24
• Completion: 2019-07-24
• First posted: 2016-05-12
• Last updated: 2022-11-29
• Results posted: 2022-08-18

Locations

64 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study