This is an open-label, multi-center study, investigating the efficacy and safety of terlipressin in Japanese patients with hepatorenal syndrome type 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Investigational site
Kansai, Japan
Investigational site
Kanto, Japan
Change in SCr value from baseline to end of treatment
Time frame: 16 days
Incidence of adverse events and its severity
Time frame: Up to 84 days
Laboratory test values
Time frame: Up to 84 days
Vital signs
Time frame: 16 days
ECG
Time frame: Day 1,4,7,10,13,16
The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL)
Time frame: 16 days
The percentage of patients showing 20% or more reduction in SCr value from the baseline
Time frame: 16 days
24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions
Time frame: 16 days
Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP)
Time frame: 16 days
Overall survival
Time frame: Up to 84 days
Pharmacokinetics - assessment of blood concentration
Time frame: Blood PK sample collection: pre-dose, 5, 15, 30, 60, 90, 120, 150, 180, 240, and 360 minutes post-dose
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