CompletedPhase 2

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

United States, Canada47 participantsStarted 2022-04-28

Plain-language 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 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 Criteria: * 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 hep…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to measurement of concentration serum creatinine (sCr) value of less than 1.5 mg/dL on 2 consecutive days

Timeframe: From Day 1 infusion start to Last Day of infusion end

Trial details

NCT IDNCT05309200

SponsorOcelot Bio, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-12

View on ClinicalTrials.gov More Cirrhosis trials