Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

NCT ID: NCT03107091

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-15
• Study Completion Date: 2019-04-25

Brief Summary

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

Detailed Description

Terlipressin continuous infusion will be adminstered via an ambulatory pump initially for 7 days in a clinical pharmacology unit. Serial blood draws for pharmacokinetic analysis will be performed to determine steady state concentration of both terlipressin and 8-lysine-vasopressin during infusion. After establishing safety and tolerance of infusion for 7 days, patients will be transitioned to an outpatient setting where they will be treated with terlipressin continuous infusion for an additional 21 days, monitored daily by home care nurses.

A total of 6 patients will be treated. Monitoring will include successful management of ascites, with reduction in paracentesis procedures and decreased ascites fluid volume, further supported by improvement in renal function.

Conditions

Cirrhosis; Ascites Hepatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terlipressin acetate continuous infusion

Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days

Group Type: EXPERIMENTAL

Terlipressin acetate continuous infusion

Intervention Type: DRUG

Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days

Interventions

Terlipressin acetate continuous infusion

Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days

Intervention Type: DRUG

Other Intervention Names

Terlipressin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioVie Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Yeramian, MD

Role: STUDY_DIRECTOR

BioVie Inc.

Locations

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CIT-001

Identifier Type: -

Identifier Source: org_study_id