Suspended
Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
What is being tested
Data Collection
Who is eligible
Digestive System Diseases+2
+ Liver Diseases
+ Liver Failure
+3 Eligibility Criteria
How is it accessible
Suspended
Available upon a request by a licensed MDExpanded Access
Summary
Principal SponsorOcera Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
This is an open-label study in patients diagnosed with ALF who are not responding to the institution's standards of care. Standard of care may include, but is not limited to, administration of N-acetylcysteine, lactulose, hypothermia therapy, and consideration for orthotopic liver transplant.
Official TitleEmergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
Principal SponsorOcera Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesLiver DiseasesLiver FailureLiver Failure, AcuteHepatic Insufficiency
Criteria
2 inclusion criteria required to participate
International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
Venous ammonia level of ≥ 100 μmol/L
1 exclusion criteria prevent from participating
Patients who are pregnant
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
SuspendedOne Study Center