A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multi-center study, investigating the efficacy and safety of terlipressin in Japanese patients with hepatorenal syndrome type 1.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Lypressin; Terlipressin

Criteria

Inclusion Criteria:

• Patients who were diagnosed with HRS type 1 according to the diagnostic criteria of HRS and whose serum creatinine value (SCr) doubled at 2.5 mg/dL or greater within 2 weeks or whose 24h creatinine clearance (Ccr) decreased by half at less than 20 mL/min.

Patients should meet all the following 5 criteria:

[Modified International Ascites Club's Diagnostic criteria of HRS]

1. Chronic or acute liver disease with advanced hepatic failure and portal hypertension.

2. Low glomerular filtration rate (SCr >1.5 mg/dL or 24h Ccr <40 mL/min)

3. Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug

4. No sustained improvement in renal function (decrease in SCr to 1.5 mg/dL or less or increase in 24h Ccr to 40 mL/min or more) following diuretic withdrawal and expansion of plasma volume with 1,500 mL/24h of isotonic saline for 24 to 48h.

5. Protein urea <500 mg/dL, and no ultrasonographic evidence of obstructive uropathy or parenchymal renal disease

• Age; 20 to 79 years

Exclusion Criteria:

• Cr value ≥5 mg/dL

• Child-Pugh Score ≥14

• Fulminant hepatitis

• Septic shock

• Hepatocellular carcinoma that does not meet the Milan Criteria

• Acute renal failure caused by contrast medium

• Chronic renal failure

• Bradycardia (heart rate <50/min)

• Hyponatraemia (serum Na <120 mEq/L)

• Ischemic heart diseases (angina pectoris, myocardial infarction), heart failure or clinically relevant arrhythmia

• Poor-controlled hypertension

• Arteriosclerosis obliterans or peripheral vascular disorder

• Cerebrovascular disorder

• Respiratory diseases such as chronic obstructive pulmonary disease

• Pregnant or possibly pregnant women and patients who or whose partner desire -pregnancy during the study period

• Patients considered by the investigator or sub-investigator as unsuitable to participate in the study