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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01634230
Enrollment
Unknown
Registered
2012-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Liver Failure

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.

Interventions

DRUGOCR-002

daily dose: 10 g infused over 24 hours

Sponsors

Ocera Therapeutics, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026