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

Ocera Therapeutics

Status

Conditions: Acute Liver Failure

Treatments: Drug: OCR-002

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01634230

OCR002-EmUse-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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