Clinical Trials

Inclusion Criteria:

- Signed informed consent form (ICF) by participant or their legal/authorized
representatives.

- Diagnosed with decompensated cirrhosis with ascites.

- Receiving albumin and has had appropriate diuretic withdrawal for at least 48 hrs
prior to randomization into the study.

- Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor
deems necessary for appropriate medical treatment.

- No sustained improvement in renal function after both diuretic withdrawal and plasma
volume expansion with albumin.

- Female participants must have a negative pregnancy test prior to randomization and
agree to avoid becoming pregnant during the study and for 30 days after the end of
treatment. Male participants must agree to use appropriate contraceptive methods
during the study and up to 30 days after the end of treatment.

Exclusion Criteria:

- Serum Creatinine > 3.5 mg/dL.

- Large volume paracentesis (LVP ≥4L) within 4 days of randomization.

- Pulse oximeter reading of < 90% on 2L or less.

- Sepsis and/or uncontrolled bacterial infection.

- Experienced shock within 72 hrs prior to screening.

- Model for End-Stage Liver Disease (MELD) score > 35.

- Hypertension with a Systolic BP > 140 mmHg and/ or a Diastolic BP > 100 mmHg.

- Treated with or exposed to nephrotoxic agents or has had exposure to radiographic
contrast agents within 72 hrs prior to screening.

- Has superimposed acute liver injury due to drugs, or toxins except for acute alcoholic
hepatitis.

- Proteinuria greater than 500 mg/dL.

- Impaired cardiac function as evidenced by symptoms consistent with New York Heart
Association Classification Class 2 or worse.

- Received Renal Replacement Therapy (RRT) within 4 weeks of randomization.

- Has had a Trans Jugular Intrahepatic Porto-systemic shunt (TIPS).

- Pregnant or breastfeeding.

- Diagnosed with a malignancy within the past 5 years.

- History or current evidence of any condition (COVID-19 positive with
respiratory/cardiac complications), therapy or laboratory abnormality that might
confound the results of the study, interfere with the participation for the full
duration of the study, or is not in the best interest to participate in the opinion of
the investigator.

- Participated in a study of an investigational medical product or device within the
last 8 weeks preceding screening.

- Experienced a major blood loss (≥ 500 mL) within the last 4 weeks prior to screening.

- Is stuporous or comatose at screening (West Haven scores III and IV) exhibiting
bradycardia.

Eligibility last updated 8/4/22. Questions regarding updates should be directed to the study team contact.