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

N/ANo Longer AvailableNCT01634230

Ocera Therapeutics, Inc.

Overview

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.

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 Type

EXPANDED_ACCESS

Conditions

Acute Liver Failure

Interventions

OCR-002DRUG

daily dose: 10 g infused over 24 hours

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University of Arkansas

Little Rock, Arkansas, United States

Data from ClinicalTrials.gov

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