Status:
COMPLETED
Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1
Lead Sponsor:
Mallinckrodt
Conditions:
Hepatorenal Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00089570
Start Date
June 1 2004
End Date
September 1 2006
Last Update
October 27 2017
Active Locations (37)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724-5136
3
UCLA School of Medicine
Los Angeles, California, United States, 90095
4
UC Davis Medical Center
Sacramento, California, United States, 95817