Completed

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1

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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
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2004
See protocol details

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
NCT00089570
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

Experimental
Terlipressin

Group II

Placebo
Placebo

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

Mayo Clinic Hospital

Phoenix, United StatesOpen Mayo Clinic Hospital in Google Maps
Suspended

University of Arizona College of Medicine

Tucson, United States
Suspended

UCLA School of Medicine

Los Angeles, United States
Suspended

UC Davis Medical Center

Sacramento, United States
Completed37 Study Centers