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

Primary Purpose

Hepatorenal Syndrome Type 1

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Terlipressin
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatorenal Syndrome Type 1

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Terlipressin

Arm Description

Outcomes

Primary Outcome Measures

Change in SCr value from baseline to end of treatment

Secondary Outcome Measures

Incidence of adverse events and its severity
Laboratory test values
Vital signs
ECG
The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL)
The percentage of patients showing 20% or more reduction in SCr value from the baseline
24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions
Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP)
Overall survival
Pharmacokinetics - assessment of blood concentration

Full Information

First Posted
June 10, 2011
Last Updated
February 13, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01373606
Brief Title
A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1
Acronym
HRS
Official Title
An Exploratory Study of FE999908 in Patients With Hepatorenal Syndrome Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatorenal Syndrome Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Terlipressin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Primary Outcome Measure Information:
Title
Change in SCr value from baseline to end of treatment
Time Frame
16 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events and its severity
Time Frame
Up to 84 days
Title
Laboratory test values
Time Frame
Up to 84 days
Title
Vital signs
Time Frame
16 days
Title
ECG
Time Frame
Day 1,4,7,10,13,16
Title
The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL)
Time Frame
16 days
Title
The percentage of patients showing 20% or more reduction in SCr value from the baseline
Time Frame
16 days
Title
24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions
Time Frame
16 days
Title
Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP)
Time Frame
16 days
Title
Overall survival
Time Frame
Up to 84 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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] Chronic or acute liver disease with advanced hepatic failure and portal hypertension. Low glomerular filtration rate (SCr >1.5 mg/dL or 24h Ccr <40 mL/min) Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Kansai
Country
Japan
Facility Name
Investigational site
City
Kanto
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22038555
Citation
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.
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A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

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