A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatorenal Syndrome

In brief

This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.

Key facts

Study ID: NCT01143246
Run by: Mallinckrodt
People needed: 196
Starts: 2010-10-11
Expected to finish: 2013-05-10
Last updated by the study team: 2022-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written informed consent by subject or legally authorized representative
At least 18 years of age
Cirrhosis and ascites
Rapidly progressive reduction in renal function characterized by:
Serum creatinine (SCr) ≥ 2.5 mg/dL
Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based criteria for proportional increases likely to be representative of at least a doubling within 2 weeks
No sustained improvement in renal function (< 20% decrease in SCr and SCr ≥ 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin:
Note: Albumin doses recommended by the International Ascites Club (IAC) are 1 g/kg on the first day (Maximum 100 g) and 20 - 40 g/day thereafter as clinically indicated. It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period.
Note: The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge. The qualifying SCr value must be ≥ 2.25 mg/dL AND at least 80% of the diagnostic (pre-fluid challenge) SCr value.

You may not qualify if…

SCr > 7 mg/dL
Shock Note: Hypotension (Mean Arterial Pressure < 70 mm Hg or a decrease > 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation.
Sepsis or systemic inflammatory response syndrome (SIRS)
Note: SIRS: Presence of 2 or more of the following findings:
Temperature > 38°C or < 36°C; heart rate > 90/min; respiratory rate of > 20/min or a PaCO2 of < 32 mm Hg; white blood cell count of > 12,000 cells/µL or < 4,000/ µL.
Note: Sepsis: Documented infection and systemic inflammatory response syndrome.
< 2 days anti-infective therapy for documented or suspected infection
Proteinuria > 500 mg/day
Hematuria or microhematuria (> 50 red blood cells per high power field)
Clinically significant casts on urinalysis, including granular casts Note: Urine sediment examination is required to exclude presence of granular casts and other clinically significant casts [e.g., red blood cell (RBC) casts].
Evidence of intrinsic or parenchymal renal disease (including acute tubular necrosis)
Obstructive uropathy or other renal pathology on ultrasound or other medical imaging
Current or recent treatment (within 4 weeks) with nephrotoxic drugs, e.g., aminoglycosides, nonsteroidal anti-inflammatory drugs (NSAID) Note: Up to 3 doses of an NSAID within the prior month (prescription or over the counter) is acceptable Note: Use of short-term (< 2 weeks) oral neomycin for acute encephalopathy is acceptable.
Current or recent (within 4 weeks) renal replacement therapy
Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning)
Current or recent treatment (within 48 hours) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
Severe cardiovascular disease as judged by investigator
Estimated life expectancy of less than 3 days
Confirmed pregnancy
Known allergy or sensitivity to terlipressin or another component of the study treatment
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization

Where it is running

Banner Good Samaritan Medical Center/Liver Disease Center — Phoenix, Arizona, United States
Mayo Clinic Arizona — Phoenix, Arizona, United States
University of Arizona Medical Center South Campus — Tucson, Arizona, United States
University of Arizona Liver Research Institute — Tucson, Arizona, United States
Arrowhead Regional Medical Center — Colton, California, United States
SCTI Research Foundation — Coronado, California, United States
Scripps Clinic — La Jolla, California, United States
USC University Hospital — Los Angeles, California, United States
UC Davis Medical Center — Sacramento, California, United States
Veteran's Administration Medical Center — San Diego, California, United States
California Pacific Medical Center — San Francisco, California, United States
University of Colorado Denver — Aurora, Colorado, United States
Hartford Hospital — Hartford, Connecticut, United States
Yale University School of Medicine — New Haven, Connecticut, United States
Georgetown University Hospital — Washington D.C., District of Columbia, United States
Mayo Clinic — Jacksonville, Florida, United States
University of Miami — Miami, Florida, United States
Emory University Hospital — Atlanta, Georgia, United States
Northwestern University — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Loyola University Medical Center — Maywood, Illinois, United States
Indiana University Health - University Hospital — Indianapolis, Indiana, United States
Iowa City VA Health Care System — Iowa City, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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