Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

NCT03107091 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CIT-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cirrhosis; Ascites Hepatic

Keywords

Terlipressin; Terlipressin acetate

Outcome Measures

Primary Outcomes (2)

• Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites

  Rate of treatment emergent adverse events assessed by physical examination and laboratory safety

  28 day treatment period and 28 day post-treatment

• Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites

  Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css)

  7 day treatment

Secondary Outcomes (1)

• Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin

  28 day post-treatment

Study Arms (1)

Terlipressin acetate continuous infusion

EXPERIMENTAL

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

Drug: Terlipressin acetate continuous infusion

Interventions

Terlipressin acetate continuous infusion DRUG

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

Also known as: Terlipressin

Terlipressin acetate continuous infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• BioVie Inc.: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23239, United States

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Penelope Markham
• Organization: BioVie

pmarkham@biovieinc.com

17035989972

Study Officials

• Patrick Yeramian, MD

  BioVie Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label prospective study in a cohort of 6 patients

Study Record Dates

• First Submitted: November 20, 2016
• First Posted: April 11, 2017
• Study Start: July 15, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 25, 2019
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)