A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

Completed · Phase 2 · Has a placebo group

Conditions studied: Cirrhosis, Ascites, Hepatorenal Syndrome, Acute Kidney Injury

In brief

OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute Kidney Injury as a complication of cirrhosis with ascites. The study aims are to evaluate the safety and efficacy of OCE-205 at various doses. Participants will receive treatment by intravenous infusion. Participants will continue with this treatment until participants meets primary endpoint or any discontinuation criteria.

Key facts

Study ID

NCT05309200

Run by

Ocelot Bio, Inc

People needed

47

Starts

2022-04-28

Expected to finish

2023-10-13

Last updated by the study team

2023-12-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 2 days 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 2 effective contraceptive methods during the study and up to 30 days after the end of treatment.

You may not qualify if…

• Serum Creatinine >3.8 mg/dL.
• Large volume paracentesis (LVP ≥6L) 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.

Where it is running

• Mayo Clinic - Phoenix — Phoenix, Arizona, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• University of California, San Francisco Liver Clinic — San Francisco, California, United States
• Stanford Hospital — Stanford, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Tampa General Medical Group — Tampa, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• Northwestern Medicine — Chicago, Illinois, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Missouri — Columbia, Missouri, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• New York-Presbyterian Hospital — New York, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor University — Dallas, Texas, United States
• CHI St Luke's Health Baylor College of Medicine Medical Center — Houston, Texas, United States
• McGuire VA Medical Center — Richmond, Virginia, United States
• Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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