Emergency Use of OCR-002 in Acute Liver Failure (ALF)

Acute Liver Failure Clinical Trial

Official title:

Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01634230
• Other study ID #: OCR002-EmUse-001
• Status: No longer available

Study information

• Verified date: June 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Failure
• Emergencies
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

Intervention

Drug:
• OCR-002
daily dose: 10 g infused over 24 hours

Locations

Country	Name	City	State
United States	University of Arkansas	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Ocera Therapeutics, Inc.

Country where clinical trial is conducted

United States,