Phase 2 N=6 Treatment

Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Cirrhosis · Ascites Hepatic

Bottom Line

View on ClinicalTrials.gov: NCT03107091 ↗

Enrolled (actual)

Serious AEs

66.7%

Results posted

Jul 2021

Primary outcome: Primary: Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites — 6; 4; 3; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Terlipressin acetate continuous infusion (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: BioVie Inc.
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites	6; 4; 3; 0; 3; 4	—
PRIMARY Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites	2.48; 0.089	—
SECONDARY Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin	-66.5; 128	—

Summary

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

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT03107091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.