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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocera Therapeutics; Ocera Therapeutics, Inc.
• Treatments: Phenylacetic acid

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