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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
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatorenal Syndrome Type 1
 Drug: Terlipressin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Study of FE999908 in Patients With Hepatorenal Syndrome Type 1

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change in SCr value from baseline to end of treatment [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Terlipressin Drug: Terlipressin

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373606

Locations
Japan
Investigational site
Kansai, Japan
Investigational site
Kanto, Japan
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications:

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01373606     History of Changes
Other Study ID Numbers: FE999908 CS01
Study First Received: June 10, 2011
Last Updated: February 13, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Terlipressin
Lypressin
Vasoconstrictor Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on May 21, 2013