A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

An Exploratory Study of FE999908 in Patients With Hepatorenal Syndrome Type 1

NCT01373606•Ferring Pharmaceuticals

Summary

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

Eligibility

Age

20 - 79 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (2)

Investigational site

Kansai, Japan

Investigational site

Kanto, Japan

Key Dates

Start Date

November 1, 2007

Primary Completion Date

March 1, 2009

Completion Date

December 1, 2009

Last Updated

February 14, 2012

Enrollment

ACTUAL participants

Conditions

Hepatorenal Syndrome Type 1

Interventions

Terlipressin

DRUG