Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Completed · Phase 2

Conditions studied: Cirrhosis, Ascites Hepatic

In brief

Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.

Key facts

Study ID

NCT03107091

Run by

BioVie Inc.

People needed

6

Starts

2017-07-15

Expected to finish

2019-04-25

Last updated by the study team

2021-07-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days

You may not qualify if…

• Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
• Total bilirubin > 5 mg/dL
• Blood clotting International normalized ratio (INR) > 2.5
• Serum creatinine > 2.0 mg/dL
• Current or recent (within 3 months of consent) renal dialysis
• Hepatic encephalopathy grade 3 or 4
• Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning)
• Current or recent treatment (within 7 days) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
• Respiratory failure requiring positive airway pressure devices or intubation
• SIRS/sepsis episode in the previous 28 days from consent
• Episode of spontaneous bacterial peritonitis or gastrointestinal hemorrhage within 28 days of consent
• Ongoing documented or suspected infection
• Severe cardiovascular disease that are contraindication to terlipressin therapy such as advanced arteriosclerosis, arrhythmia, coronary insufficiency or uncontrolled hypertension
• Findings suggestive of organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive or other renal pathology)
• Severe comorbidity that in the opinion of the Investigator would affect short-term prognosis and/or disallow safe participation in the trial (such as for example, severe anemia or pancytopenia, advanced neoplasia, hepatocellular carcinoma [confirmed with serum alpha1-fetoprotein testing], severe chronic obstructive pulmonary disease or asthma)
• Alcoholics who have not been abstinent for the past 6 months
• Transjugular intrahepatic portosystemic shunt or other surgical shunt
• For female patients: Confirmed pregnancy
• Known allergy or hypersensitivity to terlipressin
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of consent.

Where it is running

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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