Clinical Trial: Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
Brief Summary: The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.
Detailed Summary:
Sponsor: Orphan Therapeutics
Current Primary Outcome: Treatment Success [ Time Frame: Day 14 ]
Original Primary Outcome: Survival with reversal of HRS
Current Secondary Outcome: Renal function and survival [ Time Frame: Renal funtion to Day 14 and Survival to Day 180 ]
Original Secondary Outcome: Renal function and survival
Information By: Orphan Therapeutics
Dates:
Date Received: August 6, 2004
Date Started: June 2004
Date Completion:
Last Updated: February 18, 2013
Last Verified: February 2013