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.
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) * OCE-205 at 15 micrograms per hour (µg/hr) * OCE-205 at 30 micrograms per hour (µg/hr) * OCE-205 at 50 micrograms per hour (µg/hr) This multi-center trial will be conducted in the United States and Canada. If selected for the study, participants will be randomly assigned to 1 of the 5 treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
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
...and 13 more locations
Time to measurement of concentration serum creatinine (sCr) value of less than 1.5 mg/dL on 2 consecutive days
Time frame: From Day 1 infusion start to Last Day of infusion end
Mean Concentration of OCE-205 at Steady State Concentration (Css)
Time frame: From Day 1 infusion start to Last Day of infusion end
Rate of Total Body Clearance (CL) of OCE-205
Time frame: From Day 1 infusion start to Last Day of infusion end
Time to Elimination Half-Life (t1/2) of OCE-205
Time frame: From Day 1 infusion start to Last Day of infusion end
Volume of Steady-State Volume of Distribution (Vss) of OCE-205
Time frame: From Day 1 infusion start to Last Day of infusion end
Change in Mean Arterial Pressure (MAP) rate
Time frame: From Day 1 infusion start to Last Day of infusion end
Percentage Change in rate of Mean Arterial Pressure (MAP)
Time frame: From Day 1 infusion start to Last Day of infusion end
Change in Pulse Rate
Time frame: From Day 1 infusion start to Last Day of infusion end
Percentage Change in Pulse Rate
Time frame: From Day 1 infusion start to Last Day of infusion end
Change in concentration of Serum Creatinine (sCr)
Time frame: From Day 1 infusion start to Last Day of infusion end
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