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A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1 (HRS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01373606
First received: June 10, 2011
Last updated: February 13, 2012
Last verified: February 2012

June 10, 2011
February 13, 2012
November 2007
March 2009   (final data collection date for primary outcome measure)
Change in SCr value from baseline to end of treatment [ Time Frame: 16 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01373606 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events and its severity [ Time Frame: Up to 84 days ] [ Designated as safety issue: Yes ]
  • Laboratory test values [ Time Frame: Up to 84 days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Day 1,4,7,10,13,16 ] [ Designated as safety issue: Yes ]
  • The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • The percentage of patients showing 20% or more reduction in SCr value from the baseline [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • 24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 84 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1
An Exploratory Study of FE999908 in Patients With Hepatorenal Syndrome Type 1

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

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatorenal Syndrome Type 1
Drug: Terlipressin
Experimental: Terlipressin
Intervention: Drug: Terlipressin
Narahara Y, Kanazawa H, Sakamoto C, Maruyama H, Yokosuka O, Mochida S, Uemura M, Fukui H, Sumino Y, Matsuzaki Y, Masaki N, Kokubu S, Okita K. The efficacy and safety of terlipressin and albumin in patients with type 1 hepatorenal syndrome: a multicenter, open-label, explorative study. J Gastroenterol. 2012 Mar;47(3):313-20. doi: 10.1007/s00535-011-0485-8. Epub 2011 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01373606
FE999908 CS01
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP