A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

Phase 1

Completed

• Conditions: Hepatorenal Syndrome Type 1
• Interventions: Drug: Terlipressin

• Registration Number: NCT01373606
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-03
• Study Completion: 2009-12
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Terlipressin	Terlipressin	-

Primary Outcome Measures

Name	Time	Method
Change in SCr value from baseline to end of treatment	16 days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and its severity	Up to 84 days
Laboratory test values	Up to 84 days
Vital signs	16 days
ECG	Day 1,4,7,10,13,16
The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL)	16 days
The percentage of patients showing 20% or more reduction in SCr value from the baseline	16 days
24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions	16 days
Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP)	16 days
Overall survival	Up to 84 days
Pharmacokinetics - assessment of blood concentration	Blood PK sample collection: pre-dose, 5, 15, 30, 60, 90, 120, 150, 180, 240, and 360 minutes post-dose

Trial Locations

Locations (1)

Investigational site; 🇯🇵 Kanto, Japan