Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

• Status: Completed
• Trial end date: 2019-04-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioVie Inc.
• Treatments: Lypressin; Terlipressin

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.