NCT05309200

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

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Adaptive Dose-Ranging Study to Assess Safety and Efficacy of Intravenous OCE-205 in Adults Diagnosed With Cirrhosis With Ascites Who Have Developed Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Ocelot Bio, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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) * 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.

Conditions

• Cirrhosis
• Ascites
• Hepatorenal Syndrome
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	OCE-205	The drug product, OCE-205, is a sterile solution to be used for intravenous infusion.
DRUG	Placebo	Placebo to match OCE-205 is a sterile solution to be used for intravenous infusion.

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-09-12
• Completion: 2023-10-13
• First posted: 2022-04-04
• Last updated: 2023-12-15

Locations

23 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study