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A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury
NCT05309200 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2023-10-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05309200
The ClinicalTrials.gov registry entry for NCT05309200 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocelot Bio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05309200 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Minnesota, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05309200?
The interventions under investigation include: Placebo (DRUG), OCE-205 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05309200?
This trial is sponsored by Ocelot Bio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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