Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hepatorenal Syndrome	Drug: terlipressin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1

Further study details as provided by Orphan Therapeutics:

Primary Outcome Measures:

Treatment Success [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Renal function and survival [ Time Frame: Renal funtion to Day 14 and Survival to Day 180 ] [ Designated as safety issue: No ]

Enrollment:	112
Study Start Date:	June 2004
Study Completion Date:	September 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Terlipressin Terlipressin	Drug: terlipressin Other Name: terlipressin
Placebo Comparator: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089570

Show 37 Study Locations

Sponsors and Collaborators

Orphan Therapeutics

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

More Information

Publications:

Arroyo V, Guevara M, Gines P. Hepatorenal syndrome in cirrhosis: pathogenesis and treatment. Gastroenterology. 2002 May;122(6):1658-76. Review. No abstract available.

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.

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. No abstract available.

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.

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.

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.

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.

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.

Suzuki H, Stanley AJ. Current management and novel therapeutic strategies for refractory ascites and hepatorenal syndrome. QJM. 2001 Jun;94(6):293-300. Review.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sanyal AJ, Boyer T, Garcia-Tsao G, Regenstein F, Rossaro L, Appenrodt B, Blei A, Gülberg 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. Epub 2008 Feb 13.

Responsible Party:	Orphan Therapeutics
ClinicalTrials.gov Identifier:	NCT00089570 History of Changes
Other Study ID Numbers:	OT-0401
Study First Received:	August 6, 2004
Last Updated:	February 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Orphan Therapeutics:

hepatorenal syndrome
terlipressin

Additional relevant MeSH terms:

Hepatorenal Syndrome
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Terlipressin
Lypressin
Vasoconstrictor Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on June 13, 2013