Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt; Orphan Therapeutics
• Treatments: Lypressin; Terlipressin

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