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

NCT ID: NCT01634230

Last Updated: 2021-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Liver Failure

Interventions

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OCR-002

daily dose: 10 g infused over 24 hours

Intervention Type DRUG

Other Intervention Names

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ornithine phenylacetate

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocera Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Ocera Therapeutics

Locations

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University of Arkansas

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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OCR002-EmUse-001

Identifier Type: -

Identifier Source: org_study_id

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