Emergency Use of OCR-002 in Acute Liver Failure (ALF)
Sponsor
Ocera Therapeutics, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT01634230
Collaborator
(none)
1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Study Type:
Expanded Access
Official Title:
Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas | Little Rock | Arkansas | United States | 72205 |
Sponsors and Collaborators
- Ocera Therapeutics, Inc.
Investigators
- Study Director: Global Clinical Leader, Ocera Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ocera Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01634230
Other Study ID Numbers:
- OCR002-EmUse-001
First Posted:
Jul 6, 2012
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Additional relevant MeSH terms: