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COMPLETEDPHASE3

Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

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

NCT00089570•Mallinckrodt

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (37)

Mayo Clinic Hospital

Phoenix, Arizona, United States

University of Arizona College of Medicine

Tucson, Arizona, United States

UCLA School of Medicine

Los Angeles, California, United States

UC Davis Medical Center

Sacramento, California, United States

UCSD Medical Center Hillcrest

San Diego, California, United States

VA Medical Center

San Diego, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado Hospital & Health Sciences Center

Denver, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Key Dates

Start Date

June 1, 2004

Primary Completion Date

March 1, 2006

Completion Date

September 1, 2006

Last Updated

October 27, 2017

Enrollment

112

ACTUAL participants

Conditions

Hepatorenal Syndrome

Interventions

terlipressin

DRUG

Placebo

DRUG

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

NCT06256432

Hepatorenal SyndromeLiver Cirrhosis+2 more

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COMPLETEDPHASE2

A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

NCT05309200

CirrhosisAscites+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Inclusion Criteria

Exclusion Criteria

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome

Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury

Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1