A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites

NCT04112199 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: CIT-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 10

Brief Summary

This study evaluates the addition of BIV201 (terlipressin diacetate) as a continuous infusion in addition to standard of care (diuretics and therapeutic paracentesis) for reduction of ascites and complications in adult patients with refractory ascites secondary to decompensated cirrhosis

Conditions

Ascites; Decompensated Cirrhosis

Keywords

Terlipressin; Refractory ascites

Outcome Measures

Primary Outcomes (1)

• Incidence of complications, at least grade 2 severity

  Incidence of complications, at least grade 2, during the 180 days following randomization

  180 days following randomization

Secondary Outcomes (1)

• Change in cumulative ascites

  12 weeks

Study Arms (2)

BIV201 plus Standard of Care

EXPERIMENTAL

BIV201 continuous infusion - treatment for two 28 day cycles.

Drug: BIV201 continuous infusion

Standard of care

NO INTERVENTION

Per AASLD guidelines: diuretics and therapeutic paracentesis

Interventions

BIV201 continuous infusion DRUG

BIV201 continuous infusion with terlipressin for a total of two 28 day cycles. Initiate treatment at 3 mg per 24 hour period and titrate stepwise up to a maximum of 8 mg per 24 hour period based on tolerability and response.

Also known as: terlipressin diacetate

BIV201 plus Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent prior to any study-related procedures
• Male or female patients age 18 to 75 years old
• Cirrhosis of the liver (Non-alcoholic steatohepatitis, alcohol, viral and autoimmune)
• Patient has diuretic-resistant, intractable ascites or is unsuitable for treatment with diuretics and required:
• o In the 60-day period from the last LVP before consent, required, between 3 and 9 LVPs, including the last LVP on or before the day of consent.
• Dates for all LVPs that occurred within 90 days prior to consent have been recorded. The volume of ascites removed at each of the LVPs must also have been recorded for the 90-day period prior to the last LVPs before consent
• Serum creatinine (SCr) ≤2.00 mg/dL determined prior to randomization
• Women of child-bearing potential (e.g. not post-menopausal for at least one year or surgically sterile) must be neither pregnant nor lactating and must agree to use adequate birth control or be abstinent for the duration of the study
• If patient is treated with ACE inhibitors or beta blockers, dose has been stable for at least 30 days prior to randomization and may be maintained on that dose for the trial duration
• If patient is treated with diuretics, patient has been on a stable daily dose for at least 10 days prior to consent
• Willing and able to comply with trial instructions

You may not qualify if:

• Ascites with causes other than cirrhosis; such as cardiac or nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
• Urinary sodium excretion \>100 mmol/day between day of consent and randomization
• Total bilirubin \>5 mg/dL
• Blood clotting International normalized ratio (INR) \>2.5
• Current or recent (within 3 months of consent) renal replacement therapy
• Current or recent (within 3 month of consent) hepatic encephalopathy Grade 3 or 4 (West-Haven)
• Superimposed acute liver failure/injury due to factors including acute alcoholic hepatitis, acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom \[Amanita\] poisoning)
• History or presence of hepatic hydrothorax, known pulmonary hypertension and a history of hepatopulmonary syndrome
• Current or recent treatment (within 7 days of randomization) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
• Current or recent (in the previous 60 days from consent) episode of respiratory failure requiring positive airway pressure (PAP) devices or intubation
• Sepsis episode in the previous 28 days from consent
• Episode of SBP within the 28 days prior to consent
• Episode of gastrointestinal hemorrhage (non-variceal) within 28 days prior to consent
• Episode of esophageal variceal bleed within one week prior to consent
• Ongoing documented or suspected infection

Sponsors & Collaborators

• BioVie Inc.: lead

Study Sites (10)

UCLA

Los Angeles, California, 90095, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Hunter Holmes McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Palumbo, MD

  BioVie Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Thirty patients will be randomized to either BIV201 continuous infusion plus SOC or SOC alone.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: June 17, 2021
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)