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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00089570
Other study ID # OT-0401
Secondary ID
Status Completed
Phase Phase 3
First received August 6, 2004
Last updated October 25, 2017
Start date June 2004
Est. completion date September 2006

Study information

Verified date October 2017
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date September 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
terlipressin

Placebo


Locations

Country Name City State
United States The Johns Hopkins Hospital Baltimore Maryland
United States Lahey Clinic Burlington Massachusetts
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern Memorial Hospital Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States University of Texas Southwestern Medical Center of Dallas Dallas Texas
United States University of Colorado Hospital & Health Sciences Center Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States St. Luke's Episcopal Hospital, St. Luke's Texas Liver Institute Houston Texas
United States Mayo Clinic Jacksonville Jacksonville Florida
United States UCLA School of Medicine Los Angeles California
United States Methodist University Hospital Memphis Tennessee
United States Fairview-University Medical Center Minneapolis Minnesota
United States Yale New Haven Hospital New Haven Connecticut
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Center for Liver Disease & Transplantation Clinic New York New York
United States Mount Sinai Medical Center/Mount Sinai Hospital New York New York
United States Weill Cornell Medical Center New York New York
United States University of Medicine & Dentistry of New Jersey - NJMS Newark New Jersey
United States 983285 Nebraska Medical Center Omaha Nebraska
United States Albert Einstein Medical Center Philadelphia Pennsylvania
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Hospital Phoenix Arizona
United States Oregon Health Sciences University Portland Oregon
United States VCU Medical Center Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States UC Davis Medical Center Sacramento California
United States Washington University School of Medicine Saint Louis Missouri
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 Washington Medical Center Seattle Washington
United States University of Arizona College of Medicine Tucson Arizona
United States Georgetown University Hospital Washington, D.C. District of Columbia
United States VA CT Health Care System West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

References & Publications (10)

Arroyo V, Guevara M, Ginès P. Hepatorenal syndrome in cirrhosis: pathogenesis and treatment. Gastroenterology. 2002 May;122(6):1658-76. Review. — View Citation

Colle I, Durand F, Pessione F, Rassiat E, Bernuau J, Barrière 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. — View 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. — View 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. — View 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. — View Citation

Moreau R, Durand F, Poynard T, Duhamel C, Cervoni JP, Ichaï 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. — View 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. — View 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. — View Citation

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

Uriz J, Ginès P, Cárdenas A, Sort P, Jiménez W, Salmerón JM, Bataller R, Mas A, Navasa M, Arroyo V, Rodés J. Terlipressin plus albumin infusion: an effective and safe therapy of hepatorenal syndrome. J Hepatol. 2000 Jul;33(1):43-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Success Day 14
Secondary Renal function and survival Renal funtion to Day 14 and Survival to Day 180
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