Trial | NCT00089570  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    terlipressin ...

  • Study Participants

    112
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 Started
Jun 30
2004
Primary Completion
Mar 31
2006
Study Completion
Sep 30
2006
Last Update
Oct 27
2017

Drug terlipressin

Drug Placebo

Terlipressin Experimental

Terlipressin

Placebo Placebo Comparator

Placebo

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
No Results Posted