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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373606
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : February 14, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatorenal Syndrome Type 1 Drug: Terlipressin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study of FE999908 in Patients With Hepatorenal Syndrome Type 1
Study Start Date : November 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Terlipressin Drug: Terlipressin

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

Secondary Outcome Measures :
  1. Incidence of adverse events and its severity [ Time Frame: Up to 84 days ]
  2. Laboratory test values [ Time Frame: Up to 84 days ]
  3. Vital signs [ Time Frame: 16 days ]
  4. ECG [ Time Frame: Day 1,4,7,10,13,16 ]
  5. The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL) [ Time Frame: 16 days ]
  6. The percentage of patients showing 20% or more reduction in SCr value from the baseline [ Time Frame: 16 days ]
  7. 24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions [ Time Frame: 16 days ]
  8. Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP) [ Time Frame: 16 days ]
  9. Overall survival [ Time Frame: Up to 84 days ]
  10. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01373606

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

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Responsible Party: Ferring Pharmaceuticals Identifier: NCT01373606    
Other Study ID Numbers: FE999908 CS01
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Hepatorenal Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Antihypertensive Agents
Vasoconstrictor Agents