Status:
COMPLETED
A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury
Lead Sponsor:
Ocelot Bio, Inc
Conditions:
Cirrhosis
Ascites
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ef...
Detailed Description
The study will include 5 treatment arms including 1 Placebo Arm and 4 active drug arms. Participants will be randomly selected to 1 of 5 arms. * Placebo * OCE-205 at 8 micrograms per hour (µg/hr) * O...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT05309200
Start Date
April 28 2022
End Date
October 13 2023
Last Update
December 15 2023
Active Locations (23)
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1
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
2
Keck Medical Center of USC
Los Angeles, California, United States, 90033
3
University of California, San Francisco Liver Clinic
San Francisco, California, United States, 94143
4
Stanford Hospital
Stanford, California, United States, 94305