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NCT05309200 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acute Kidney Injury and Cirrhosis, sponsored by Ocelot Bio.

Completed
Registry status
Phase 2
Development phase
47
Enrollment target
20
Study locations

NCT05309200 is a Phase 2 study of Acute Kidney Injury and Cirrhosis that has completed, run by Ocelot Bio. The registered enrollment target is 47 participants, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05309200, a Phase 2 study of Acute Kidney Injury and Cirrhosis, has completed, sponsored by Ocelot Bio.

COMPLETED
Registry status
Phase 2
Development phase
47 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DRUG Placebo
  • DRUG OCE-205

Study Locations (20)

California

  • Keck Medical Center of USC - Los Angeles
  • University of California, San Francisco Liver Clinic - San Francisco
  • Stanford Hospital - Stanford

Minnesota

  • M Health Fairview University of Minnesota Medical Center - Minneapolis
  • Mayo Clinic - Rochester

Texas

  • Baylor University - Dallas
  • CHI St Luke's Health Baylor College of Medicine Medical Center - Houston

Arizona

  • Mayo Clinic - Phoenix - Phoenix

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Florida

  • Tampa General Medical Group - Tampa

Georgia

  • Piedmont Atlanta Hospital - Atlanta

Illinois

  • Northwestern Medicine - Chicago

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2022-04-28
Est. Completion 2023-10-13
Phase Phase 2

Sponsor

Ocelot Bio

1 total trials

What the Registry Record Tells You About NCT05309200

The ClinicalTrials.gov registry entry for NCT05309200 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (98% lower). The listed sponsor is Ocelot Bio, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05309200 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Minnesota, Texas.

Frequently Asked Questions

What is clinical trial NCT05309200 about?

NCT05309200 is a clinical study titled "A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury". 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. Pa...

What is the current status of trial NCT05309200?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2022-04-28. Estimated completion is 2023-10-13.

What conditions does trial NCT05309200 study?

This clinical trial studies the following conditions: Acute Kidney Injury, Cirrhosis, Ascites, Hepatorenal Syndrome.

What interventions are being tested in trial NCT05309200?

The interventions under investigation include: Placebo (DRUG), OCE-205 (DRUG).

Who is sponsoring clinical trial NCT05309200?

This trial is sponsored by Ocelot Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05309200 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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