Hepatorenal Syndrome Type 1 Clinical Trial
— HRSOfficial title:
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 79 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Investigational site | Kansai | |
| Japan | Investigational site | Kanto |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Japan,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in SCr value from baseline to end of treatment | 16 days | No | |
| Secondary | Incidence of adverse events and its severity | Up to 84 days | Yes | |
| Secondary | Laboratory test values | Up to 84 days | Yes | |
| Secondary | Vital signs | 16 days | Yes | |
| Secondary | ECG | Day 1,4,7,10,13,16 | Yes | |
| Secondary | The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL) | 16 days | No | |
| Secondary | The percentage of patients showing 20% or more reduction in SCr value from the baseline | 16 days | No | |
| Secondary | 24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions | 16 days | No | |
| Secondary | Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP) | 16 days | No | |
| Secondary | Overall survival | Up to 84 days | No | |
| Secondary | Pharmacokinetics - assessment of blood concentration | Blood PK sample collection: pre-dose, 5, 15, 30, 60, 90, 120, 150, 180, 240, and 360 minutes post-dose | No |