Completed
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
What is being tested
terlipressin
+ Placebo
Drug
Who is being recruted
Urogenital Diseases+6
+ Digestive System Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Over 18 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: June 2004
Summary
Principal SponsorMallinckrodt
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.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.
Official TitleA Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
Principal SponsorMallinckrodt
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
112 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesDigestive System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHepatorenal SyndromeKidney DiseasesLiver DiseasesUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases
Criteria
5 inclusion criteria required to participate
Chronic, or acute liver disease
Rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to >2.5 mg/dL in less than two weeks.
No sustained improvement in renal function after diuretic withdrawal and plasma volume expansion
Proteinuria <500 mg per day
Show More Criteria
9 exclusion criteria prevent from participating
Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose)
Ongoing shock
Uncontrolled bacterial infection
Current significant fluid losses
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalTerlipressin
Group II
PlaceboPlacebo
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 37 locations
Suspended
Suspended
University of Arizona College of Medicine
Tucson, United StatesSuspended
UCLA School of Medicine
Los Angeles, United StatesSuspended
UC Davis Medical Center
Sacramento, United StatesCompleted37 Study Centers