Clinical Trial: A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: Change in SCr value from baseline to end of treatment [ Time Frame: 16 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Ferring Pharmaceuticals

Dates:
Date Received: June 10, 2011
Date Started: November 2007
Date Completion:
Last Updated: February 13, 2012
Last Verified: February 2012