Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Mallinckrodt

Status and phase: Completed; Phase 3

Conditions: Hepatorenal Syndrome

Treatments: Drug: terlipressin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089570

OT-0401

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

Terlipressin

Experimental group

Description:

Terlipressin

Treatment:

Drug: terlipressin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo