DRUG
Terlipressin
Terlipressin solution for injection
Status
Completed
Phase
Phase 3
Enrollment
300
Locations
64
Results
Posted
Publications
6
Study 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.
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.
Interventions
DRUG
Terlipressin solution for injection
OTHER
Matching placebo solution for injection
Timeline
First posted
May 12, 2016
Study start
Jul 13, 2016
Primary completion
Jul 24, 2019
Study completion
Jul 24, 2019
Results posted
Aug 18, 2022
Registry updated
Nov 29, 2022
Outcomes
Percentage of Participants With Verified HRS Reversal
Time frame · within 15 Days
Defined as the percentage of participants with 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart, while on treatment by Day 14 or discharge (on treatment defined as up to 24 hours after the final dose of study drug), per protocol.
Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis
Time frame · within 25 days
Defined as the percentage of participants with verified HRS reversal who lived at least 10 days without RRT, and were otherwise viable (per protocol) for inclusion in the primary endpoint analysis
Percentage of Participants With HRS Reversal
Time frame · within 14 days
Defined as the percentage of participants with a SCr value no more than 1.5 mg/dL by Day 14 or discharge, and were viable (per protocol) for inclusion in the secondary endpoint analysis
Percentage of Participants With Durable HRS Reversal
Time frame · Day 30
Defined as the percentage of participants maintaining HRS reversal without RRT to Day 30
Percentage pf Participants in the SIRS Subgroup With HRS Reversal
Time frame · within 14 days
Defined as the percentage of participants in the SIRS subgroup with HRS reversal by Day 14 or discharge
Percentage of Participants With Verified HRS Reversal Without HRS Recurrence by Day 30
Time frame · Day 30
Defined as the percentage of participants who had achieved verified HRS reversal by Day 15 or discharge and did not revert to baseline measures by day 30
Eligibility
Inclusion Criteria: * Written informed consent by participant or legally authorized representative * Cirrhosis and ascites * Rapidly progressive worsening in renal function to a serum creatinine (SCr) at least 2.25 mg/dL and meeting a trajectory for SCr to double over 2 weeks * No sustained improvement in renal function (less than 20% decrease in SCr and SCr at least 2.25 mg/dL) at least 48 hours after diuretic withdrawal and the beginning of plasma volume expansion with albumin * Discontinues midodrine and octreotide before randomization if applicable Exclusion Criteria: * Serum creatinine level greater than 7.0 mg/dL * At least 1 event of large volume paracentesis (LVP) at least 4 L within 2 days of randomization * Sepsis and/or uncontrolled bacterial infection * Less than 2 days anti-infective therapy for documented or suspected infection * Shock * Being treatment with or exposure to nephrotoxic agents, nonsteroidal anti-inflammatory drugs, or significant radiographic contrast agents (within the last 4 weeks) * Estimated life expectancy of less than 3 days * Superimposed acute liver injury due to drugs, dietary supplements, herbal preparations, viral hepatitis, or toxins, with the exception of acute alcoholic hepatitis * Proteinuria greater than 500 mg/day * Evidence of obstructive uropathy or parenchymal renal disease on ultrasound or other imaging * Tubular epithelial casts, heme granular casts, hematuria or microhematuria (greater than 50 red blood cells per high power field in the absence of recent catheterization) on urinalysis * Pregnancy; all women of child-bearing age and potential must have a negative pregnancy test * Cardiovascular disease judged by the investigator to be severe * Current or recent renal replacement therapy (RRT) within the past 4 weeks * Participation in other clinical research involving investigational medicinal products within 30 days of randomization * Transjugular intrahepatic portosystemic shunt (TIPS) within 30 days of randomization * Use of vasopressors for at least 3 consecutive days within the 14-day screening period - patients receiving any vasopressor other than midodrine and octreotide within 24 hours of qualifying SCr are also excluded, ie, a 24-hour washout is required prior to enrollment * Known allergy or sensitivity to terlipressin or another component of the study treatment
Study locations
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Mayo Clinic - AZ
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
USC Healthcare
Los Angeles, California, United States
Stanford Hospital and Clinics
Palo Alto, California, United States
UCLA Medical Center
San Diego, California, United States
Southern California Research Center
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic - FL
Jacksonville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
Piedmont Hospital Transplant
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Publications
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