Back to resultsEmergency Use of OCR-002 in Acute Liver Failure (ALF)
Primary Purpose
Acute Liver Failure
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
OCR-002
Sponsored by
About this trial
This is an expanded access trial for Acute Liver Failure
Eligibility Criteria
Inclusion Criteria:
- International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
- Venous ammonia level of ≥ 100 μmol/L
Exclusion Criteria:
- Patients who are pregnant
Sites / Locations
- University of Arkansas
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01634230
Brief Title
Emergency Use of OCR-002 in Acute Liver Failure (ALF)
Official Title
Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocera Therapeutics, Inc.
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
OCR-002
Other Intervention Name(s)
ornithine phenylacetate
Intervention Description
daily dose: 10 g infused over 24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
Venous ammonia level of ≥ 100 μmol/L
Exclusion Criteria:
Patients who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Ocera Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Emergency Use of OCR-002 in Acute Liver Failure (ALF)
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