Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

terlipressin

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+9

+ Digestive System Diseases

+ Disease

Over 18 Years
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: December 11, 2025
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: December 11, 2025
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 DiseasesDiseaseFemale Urogenital Diseases and Pregnancy ComplicationsHepatorenal SyndromeKidney DiseasesLiver DiseasesPathologic ProcessesSyndromeUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

Inclusion Criteria: * 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 * No evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease Exclusion Criteria: * Ongoing shock * Uncontrolled bacterial infection * Current significant fluid losses * Current or recent treatment with nephrotoxic drugs (e.g. NSAIDs or aminoglycosides within 4 weeks) * Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose) * Confirmed pregnancy * Severe cardiovascular disease * Evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis) * Participation in other clinical studies within 30 days

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 StatesSee the location
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