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Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Primary Purpose

Hepatorenal Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
terlipressin
Placebo
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatorenal Syndrome focused on measuring hepatorenal syndrome, terlipressin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic Hospital
  • University of Arizona College of Medicine
  • UCLA School of Medicine
  • UC Davis Medical Center
  • UCSD Medical Center Hillcrest
  • VA Medical Center
  • California Pacific Medical Center
  • University of California, San Francisco
  • University of Colorado Hospital & Health Sciences Center
  • Yale New Haven Hospital
  • VA CT Health Care System
  • Georgetown University Hospital
  • Mayo Clinic Jacksonville
  • Northwestern Memorial Hospital
  • Tulane University Health Sciences Center
  • The Johns Hopkins Hospital
  • Lahey Clinic
  • Henry Ford Hospital
  • Fairview-University Medical Center
  • Mayo Clinic
  • Washington University School of Medicine
  • 983285 Nebraska Medical Center
  • University of Medicine & Dentistry of New Jersey - NJMS
  • Weill Cornell Medical Center
  • Mount Sinai Medical Center/Mount Sinai Hospital
  • Center for Liver Disease & Transplantation Clinic
  • The University of North Carolina at Chapel Hill
  • Cleveland Clinic Foundation
  • Oregon Health Sciences University
  • Hospital of the University of Pennsylvania
  • Albert Einstein Medical Center
  • Medical University of South Carolina
  • Methodist University Hospital
  • University of Texas Southwestern Medical Center of Dallas
  • St. Luke's Episcopal Hospital, St. Luke's Texas Liver Institute
  • VCU Medical Center
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Terlipressin

Placebo

Arm Description

Terlipressin

Placebo

Outcomes

Primary Outcome Measures

Treatment Success

Secondary Outcome Measures

Renal function and survival

Full Information

First Posted
August 6, 2004
Last Updated
October 25, 2017
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00089570
Brief Title
Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatorenal Syndrome
Keywords
hepatorenal syndrome, terlipressin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Terlipressin
Arm Type
Experimental
Arm Description
Terlipressin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
terlipressin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Treatment Success
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Renal function and survival
Time Frame
Renal funtion to Day 14 and Survival to Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun J. Sanyal, M.D.
Organizational Affiliation
Medical College of Virginia, Virginia Commonwealth University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas D. Boyer, M.D.
Organizational Affiliation
University of Arizona Health Sciences Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Teuber, Ph.D.
Organizational Affiliation
Orphan Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of Arizona College of Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5136
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSD Medical Center Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103-9707
Country
United States
Facility Name
VA Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0538
Country
United States
Facility Name
University of Colorado Hospital & Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8019
Country
United States
Facility Name
VA CT Health Care System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Georgetown University Hospital
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Fairview-University Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
983285 Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3285
Country
United States
Facility Name
University of Medicine & Dentistry of New Jersey - NJMS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101-1709
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center/Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Center for Liver Disease & Transplantation Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
University of Texas Southwestern Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9151
Country
United States
Facility Name
St. Luke's Episcopal Hospital, St. Luke's Texas Liver Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6174
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12016430
Citation
Arroyo V, Guevara M, Gines P. Hepatorenal syndrome in cirrhosis: pathogenesis and treatment. Gastroenterology. 2002 May;122(6):1658-76. doi: 10.1053/gast.2002.33575. No abstract available.
Results Reference
background
PubMed Identifier
12164964
Citation
Colle I, Durand F, Pessione F, Rassiat E, Bernuau J, Barriere E, Lebrec D, Valla DC, Moreau R. Clinical course, predictive factors and prognosis in patients with cirrhosis and type 1 hepatorenal syndrome treated with Terlipressin: a retrospective analysis. J Gastroenterol Hepatol. 2002 Aug;17(8):882-8. doi: 10.1046/j.1440-1746.2002.02816.x.
Results Reference
background
PubMed Identifier
11051385
Citation
Duhamel C, Mauillon J, Berkelmans I, Bourienne A, Tranvouez JL. Hepatorenal syndrome in cirrhotic patients: terlipressine is a safe and efficient treatment; propranolol and digitalic treatments: precipitating and preventing factors? Am J Gastroenterol. 2000 Oct;95(10):2984-5. doi: 10.1111/j.1572-0241.2000.03214.x. No abstract available.
Results Reference
background
PubMed Identifier
9824265
Citation
Hadengue A, Gadano A, Moreau R, Giostra E, Durand F, Valla D, Erlinger S, Lebrec D. Beneficial effects of the 2-day administration of terlipressin in patients with cirrhosis and hepatorenal syndrome. J Hepatol. 1998 Oct;29(4):565-70. doi: 10.1016/s0168-8278(98)80151-7.
Results Reference
background
PubMed Identifier
11981339
Citation
Halimi C, Bonnard P, Bernard B, Mathurin P, Mofredj A, di Martino V, Demontis R, Henry-Biabaud E, Fievet P, Opolon P, Poynard T, Cadranel JF. Effect of terlipressin (Glypressin) on hepatorenal syndrome in cirrhotic patients: results of a multicentre pilot study. Eur J Gastroenterol Hepatol. 2002 Feb;14(2):153-8. doi: 10.1097/00042737-200202000-00009.
Results Reference
background
PubMed Identifier
11910344
Citation
Moreau R, Durand F, Poynard T, Duhamel C, Cervoni JP, Ichai P, Abergel A, Halimi C, Pauwels M, Bronowicki JP, Giostra E, Fleurot C, Gurnot D, Nouel O, Renard P, Rivoal M, Blanc P, Coumaros D, Ducloux S, Levy S, Pariente A, Perarnau JM, Roche J, Scribe-Outtas M, Valla D, Bernard B, Samuel D, Butel J, Hadengue A, Platek A, Lebrec D, Cadranel JF. Terlipressin in patients with cirrhosis and type 1 hepatorenal syndrome: a retrospective multicenter study. Gastroenterology. 2002 Apr;122(4):923-30. doi: 10.1053/gast.2002.32364.
Results Reference
background
PubMed Identifier
11322061
Citation
Mulkay JP, Louis H, Donckier V, Bourgeois N, Adler M, Deviere J, Le Moine O. Long-term terlipressin administration improves renal function in cirrhotic patients with type 1 hepatorenal syndrome: a pilot study. Acta Gastroenterol Belg. 2001 Jan-Mar;64(1):15-9.
Results Reference
background
PubMed Identifier
12542598
Citation
Solanki P, Chawla A, Garg R, Gupta R, Jain M, Sarin SK. Beneficial effects of terlipressin in hepatorenal syndrome: a prospective, randomized placebo-controlled clinical trial. J Gastroenterol Hepatol. 2003 Feb;18(2):152-6. doi: 10.1046/j.1440-1746.2003.02934.x.
Results Reference
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PubMed Identifier
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Citation
Suzuki H, Stanley AJ. Current management and novel therapeutic strategies for refractory ascites and hepatorenal syndrome. QJM. 2001 Jun;94(6):293-300. doi: 10.1093/qjmed/94.6.293.
Results Reference
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PubMed Identifier
10905585
Citation
Uriz J, Gines P, Cardenas A, Sort P, Jimenez W, Salmeron JM, Bataller R, Mas A, Navasa M, Arroyo V, Rodes J. Terlipressin plus albumin infusion: an effective and safe therapy of hepatorenal syndrome. J Hepatol. 2000 Jul;33(1):43-8. doi: 10.1016/s0168-8278(00)80158-0.
Results Reference
background
PubMed Identifier
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Citation
Sanyal AJ, Boyer TD, Frederick RT, Wong F, Rossaro L, Araya V, Vargas HE, Reddy KR, Pappas SC, Teuber P, Escalante S, Jamil K. Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the OT-0401 and REVERSE randomised clinical studies. Aliment Pharmacol Ther. 2017 Jun;45(11):1390-1402. doi: 10.1111/apt.14052. Epub 2017 Mar 29.
Results Reference
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PubMed Identifier
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Citation
Sanyal AJ, Boyer T, Garcia-Tsao G, Regenstein F, Rossaro L, Appenrodt B, Blei A, Gulberg V, Sigal S, Teuber P; Terlipressin Study Group. A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome. Gastroenterology. 2008 May;134(5):1360-8. doi: 10.1053/j.gastro.2008.02.014. Epub 2008 Feb 13.
Results Reference
derived

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Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

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