Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1
NCT ID: NCT02770716
Last Updated: 2022-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2016-07-13
2019-07-24
Brief Summary
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Out of every three participants, two will receive terlipressin and one will receive placebo.
Assignments will be made randomly.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Terlipressin
Participants receive terlipressin intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol.
Terlipressin
Terlipressin solution for injection
Placebo
Participants receive matching placebo intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol.
Placebo
Matching placebo solution for injection
Interventions
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Terlipressin
Terlipressin solution for injection
Placebo
Matching placebo solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Lead
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Mayo Clinic - FL
Jacksonville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
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
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
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - MN
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
NYU Langone Health
New York, New York, United States
Weil Cornell Medical College
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Case Western Reserve Transplant
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Drexel University
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson University
Philadelphia, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Parkland Health and Hospital System
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor Scott and White All Saints Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine (St. Luke's)
Houston, Texas, United States
Methodist Center for Liver Disease and Transplantation
Houston, Texas, United States
Methodist Transplant Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Harborview Medical Center/Univ. of Washington
Seattle, Washington, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
University of Toronto 9N/983 Toronto General Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, , Canada
Centre Hospitalier de l'Université de Montréal
Québec, , Canada
Countries
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References
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Bajaj JS, Kwo P, Pappas SC, O'Leary JG, Jamil K, Cardoza S, Wong F. Bradycardia and Other Arrhythmias in Patients With Hepatorenal Syndrome-Acute Kidney Injury Following Terlipressin Treatment: A Pooled Analysis of Three North American Phase III Clinical Studies. Aliment Pharmacol Ther. 2025 Jul 24. doi: 10.1111/apt.70297. Online ahead of print.
Mujtaba MA, Gamilla-Crudo AK, Merwat SN, Hussain SA, Kueht M, Karim A, Khattak MW, Rooney PJ, Jamil K. Terlipressin in combination with albumin as a therapy for hepatorenal syndrome in patients aged 65 years or older. Ann Hepatol. 2023 Sep-Oct;28(5):101126. doi: 10.1016/j.aohep.2023.101126. Epub 2023 Jun 10.
Velez JCQ, Wong F, Reddy KR, Sanyal AJ, Vargas HE, Curry MP, Gonzalez SA, Pappas SC, Jamil K. The Effect of Terlipressin on Renal Replacement Therapy in Patients with Hepatorenal Syndrome. Kidney360. 2023 Aug 1;4(8):1030-1038. doi: 10.34067/KID.0000000000000132. Epub 2023 May 5.
Curry MP, Vargas HE, Befeler AS, Pyrsopoulos NT, Patwardhan VR, Jamil K. Early treatment with terlipressin in patients with hepatorenal syndrome yields improved clinical outcomes in North American studies. Hepatol Commun. 2023 Jan 3;7(1):e1307. doi: 10.1097/01.HC9.0000897228.91307.0c. eCollection 2023 Jan 1.
Wong F, Pappas SC, Curry MP, Reddy KR, Rubin RA, Porayko MK, Gonzalez SA, Mumtaz K, Lim N, Simonetto DA, Sharma P, Sanyal AJ, Mayo MJ, Frederick RT, Escalante S, Jamil K; CONFIRM Study Investigators. Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome. N Engl J Med. 2021 Mar 4;384(9):818-828. doi: 10.1056/NEJMoa2008290.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MNK19013058
Identifier Type: -
Identifier Source: org_study_id
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