For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Informed consent prior to any study-related procedures
  2. Male or female patients age 18 to 75 years old
  3. Cirrhosis of the liver (Non-alcoholic steatohepatitis, alcohol, viral and autoimmune)
  4. 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.
  5. 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
  6. Serum creatinine (SCr) ≤2.00 mg/dL determined prior to randomization
  7. 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
  8. 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
  9. If patient is treated with diuretics, patient has been on a stable daily dose for at least 10 days prior to consent
  10. Willing and able to comply with trial instructions

EXCLUSION CRITERIA

  1. Ascites with causes other than cirrhosis; such as cardiac or nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
  2. Urinary sodium excretion >100 mmol/day between day of consent and randomization
  3. Total bilirubin >5 mg/dL
  4. Blood clotting International normalized ratio (INR) >2.5
  5. Current or recent (within 3 months of consent) renal replacement therapy
  6. Current or recent (within 3 month of consent) hepatic encephalopathy Grade 3 or 4 (West-Haven)
  7. 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)
  8. History or presence of hepatic hydrothorax, known pulmonary hypertension and a history of hepatopulmonary syndrome
  9. Current or recent treatment (within 7 days of randomization) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
  10. Current or recent (in the previous 60 days from consent) episode of respiratory failure requiring positive airway pressure (PAP) devices or intubation
  11. Sepsis episode in the previous 28 days from consent
  12. Episode of SBP within the 28 days prior to consent
  13. Episode of gastrointestinal hemorrhage (non-variceal) within 28 days prior to consent
  14. Episode of esophageal variceal bleed within one week prior to consent
  15. Ongoing documented or suspected infection
  16. Severe cardiovascular disease that is a contraindication to terlipressin therapy such as a history of myocardial infarction, angina pectoris, advanced arteriosclerosis, uncontrolled cardiac arrhythmia, severe coronary insufficiency or uncontrolled hypertension
  17. Findings suggestive of severe organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive renal pathology)
  18. Use of nephrotoxic drugs (e.g., aminoglycosides) in the 4 weeks before screening
  19. 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 progressive neoplasia such as hepatocellular carcinoma, unless eligible for transplant)
  20. Patient who, in the judgment of the investigator, has been an excessive alcohol drinker in the past 12 weeks
  21. Patient is in the opinion of the investigator, despite previous education on sodium restriction, anticipated to remain grossly non-compliant of sodium restricted diet
  22. Implanted alfapump or previous recipient of alfapump that had pump removed within past 3 months
  23. Recipient of renal or liver transplant
  24. Planned elective surgery related to cirrhosis complications, for example for hernia repair
  25. Known allergy or hypersensitivity to terlipressin
  26. Participation in other clinical research studies involving the treatment with other investigational drugs or evaluation with implantable devices within 30 days of consent
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 7035989972Email iconEmail Study Center

Study’s details


Contition

Ascites,Decompensated Cirrhosis

Age

18+

Phase

Phase 2

Participants needed

30

Est. Completion Date

Nov 2023

Treatment type

Interventional


Sponsor

BioVie Inc.

ClinicalTrials.gov identifier

NCT04112199

Study number

CIT-002

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