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

• Conditions: Acute Liver Failure

• Registration Number: NCT01634230
• Lead Sponsor: Ocera Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-07-02
• Study First Posted: 2012-07-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States