Emergency Use of OCR-002 in Acute Liver Failure (ALF)
Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
This study provides emergency use of the unapproved study medication in ALF patients with acute liver failure who are not responding to standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedJune 24, 2021
June 1, 2021
June 25, 2012
June 18, 2021
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
- Venous ammonia level of ≥ 100 μmol/L
You may not qualify if:
- Patients who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Ocera Therapeutics
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2012
First Posted
July 6, 2012
Last Updated
June 24, 2021
Record last verified: 2021-06