Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

October 25, 2017 updated by: Mallinckrodt

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Tucson, Arizona, United States, 85724-5136
        • University of Arizona College of Medicine
    • California
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • San Diego, California, United States, 92103-9707
        • UCSD Medical Center Hillcrest
      • San Diego, California, United States, 92161
        • VA Medical Center
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Francisco, California, United States, 94143-0538
        • University of California, San Francisco
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Hospital & Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8019
        • Yale New Haven Hospital
      • West Haven, Connecticut, United States, 06516
        • VA CT Health Care System
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • The Johns Hopkins Hospital
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Fairview-University Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3285
        • 983285 Nebraska Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07101-1709
        • University of Medicine & Dentistry of New Jersey - NJMS
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center/Mount Sinai Hospital
      • New York, New York, United States, 10032
        • Center for Liver Disease & Transplantation Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7080
        • The University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Methodist University Hospital
    • Texas
      • Dallas, Texas, United States, 75390-9151
        • University of Texas Southwestern Medical Center of Dallas
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital, St. Luke's Texas Liver Institute
    • Virginia
      • Richmond, Virginia, United States, 23298
        • VCU Medical Center
    • Washington
      • Seattle, Washington, United States, 98195-6174
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Terlipressin
Drug: terlipressin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment Success
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal function and survival
Time Frame: Renal funtion to Day 14 and Survival to Day 180
Renal funtion to Day 14 and Survival to Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Investigators

  • Study Chair: Arun J. Sanyal, M.D., Medical College of Virginia, Virginia Commonwealth University Medical Center
  • Study Director: Thomas D. Boyer, M.D., University of Arizona Health Sciences Center
  • Study Director: Peter Teuber, Ph.D., Orphan Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 6, 2004

First Submitted That Met QC Criteria

August 6, 2004

First Posted (Estimate)

August 9, 2004

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT-0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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