Acute Liver FailureNCT01634230
Emergency Use of OCR-002 in Acute Liver Failure (ALF)
A study testing OCR-002 in people with Acute Liver Failure, run by Ocera Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- OCR-002
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
- Venous ammonia level of ≥ 100 μmol/L
Who cannot join
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
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.
Read the 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.
- Conditions
- Acute Liver Failure
- Being tested
- OCR-002
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCR-002Drug
Also called ornithine phenylacetate
daily dose: 10 g infused over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Ocera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Ocera Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634230
- Sponsor's protocol ID
- OCR002-EmUse-001
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2012
- Last updated
- 24 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure
- ClinicalTrials.gov ID
- NCT01634230
- Acronym / sponsor ID
- OCR002-EmUse-001
- Conditions
- Acute Liver Failure
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Ocera Therapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
- Venous ammonia level of ≥ 100 μmol/L
Key exclusion criteria (1 listed)
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCR-002Also: ornithine phenylacetatedaily dose: 10 g infused over 24 hours | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Ocera Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCR-002 in people with Acute Liver Failure, run by Ocera Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.