A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome… (NCT05309200) | Clinical Trial Compass
CompletedPhase 2
A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury
United States47 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 range18 Years – 75 Years
SexALL
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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…
What they're measuring
1
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