CirrhosisNCT00305591
Brain Imaging in Patients With Chronic Liver Disease and Functional Impairment.
A study testing l-ornithine l-aspartate in people with Cirrhosis and Hepatic Encephalopathy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis) and involves a wide spectrum of problems from mild impairment of reaction times in driving and operating machinery through to disturbances in mood, behaviour and conscious levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Hepatic Encephalopathy
- What is being tested?
- l-ornithine l-aspartate
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2006to Oct 2007
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Biopsy-proven cirrhosis
- Clinically stable
- Able to give informed consent
- Fluent English (required for psychometric testing)
Who cannot join
- Ferro-magnetic implants
- Claustrophobia
- Weight >120kg
- Significant renal impairment (Creatinine >150 micromol/L)
- Poorly controlled Diabetes (particularly type I with microvascular complications)
- Alcohol: if alcoholic liver disease is the aetiology of their liver disease they should be abstinent. Otherwise less than 20g per day.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
Hammersmith, London, W12 0HS
About this study
Official title: Functional Magnetic Resonance Imaging and Spectroscopy of the Brain in Patients With Chronic Hepatic Encephalopathy
Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis) and involves a wide spectrum of problems from mild impairment of reaction times in driving and operating machinery through to disturbances in mood, behaviour and conscious levels.
Magnetic resonance imaging (MRI) is a method of obtaining pictures of the inside of the body. Patients with liver disease have previously been studied with MRI which has highlighted changes in the brain. This research aims to highlight some of the differences in the way that the brain functions in patients with liver disease. Using our new, more powerful MRI scanner, with more sophisticated techniques we hope that the novel combination of MRI techniques can objectively detect the presence of , and monitor HE.
Study hypothesis: Hepatic encephalopathy (HE) is a reversible, metabolic disturbance of the brain, associated with low grade brain swelling and disturbances of the chemical balance within the brain, resulting in functional impairment, the presence of which MR imaging can detect with sufficient sensitivity to monitor the changes that may occur over time in response to treatment.
Read the detailed description
Hepatic encephalopathy (HE) is a common neuropsychiatric abnormality, complicating the course of liver disease patients. In the UK, cirrhosis accounts for 4000 deaths per year, and 500,000 people are thought to be infected with chronic hepatitis C, of which up to 20% will develop cirrhosis over 20 years. The condition has been difficult to monitor objectively.
Despite the fact that the syndrome was probably first recognised two thousand years ago, the exact pathogenesis still remains unclear. It is thought to represent a reversible disturbance in brain chemistry and consequent brain swelling, in response to blood containing unfiltered gut-derived toxins entering the cerebral circulation. There is no recognised 'gold standard' test to diagnose and monitor this important, disabling condition. I have developed a novel combination of magnetic resonance imaging (MRI) sequences at 3 Tesla to study the effects of hepatic encephalopathy on the brain in patients with cirrhosis.
We propose to investigate alterations in brain size, function and chemistry before, and then at intervals after 4 weeks anti-encephalopathy treatment with L-ornithine L-aspartate. This will enable the assessment of both the baseline brain alterations of the cohort and the brain's response to therapy and correlation with their clinical response. As such this longitudinal study would allow us to define the sensitivity of the MR techniques.
Each of 50 patients will have blood tests, a 1 hour MRI brain scan and psychometric testing. The psychometric testing will be performed with both a computer-based battery and conventional paer-based tests. They will then be given L-ornithine L-aspartate (LOLA) to take orally for 4 weeks and have repeat blood tests, MRI and psychometric tests.
We will then determine if there is a correlation between the MR data and the results of the psychometric testing.
- Conditions
- Cirrhosis, Hepatic Encephalopathy
- Being tested
- l-ornithine l-aspartate
- Keywords
- magnetic resonance imaging, magnetic resonance spectroscopy, functional magnetic resonance imaging, cirrhosis, hepatic encephalopathy, l-ornithine l-aspartate
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
l-ornithine l-aspartateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
All enrolled patients will be given 4 weeks of treatment. Both MRI and functional changes will be observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startMar 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Physicians, Paddington Charitable Estates Educational Fund, University of London
- Investigators
- Simon D Taylor-Robinson, MBBS, FRCP, Principal investigator, Imperial College London & St Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305591
- Sponsor's protocol ID
- 04/Q0406/161
- Status last verified
- Jan 2008
- First submitted
- 21 Mar 2006
- Last updated
- 29 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging and Spectroscopy of the Brain in Patients With Chronic Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT00305591
- Acronym / sponsor ID
- 04/Q0406/161
- Conditions
- Cirrhosis, Hepatic Encephalopathy
- Keywords
- magnetic resonance imaging, magnetic resonance spectroscopy, functional magnetic resonance imaging, cirrhosis, hepatic encephalopathy, l-ornithine l-aspartate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal College of Physicians, Paddington Charitable Estates Educational Fund, University of London
- Study start
- Mar 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Mar 2006 (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.
Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis) and involves a wide spectrum of problems from mild impairment of reaction times in driving and operating machinery through to disturbances in mood, behaviour and conscious levels.
Magnetic resonance imaging (MRI) is a method of obtaining pictures of the inside of the body. Patients with liver disease have previously been studied with MRI which has highlighted changes in the brain. This research aims to highlight some of the differences in the way that the brain functions in patients with liver disease. Using our new, more powerful MRI scanner, with more sophisticated techniques we hope that the novel combination of MRI techniques can objectively detect the presence of , and monitor HE.
Study hypothesis: Hepatic encephalopathy (HE) is a reversible, metabolic disturbance of the brain, associated with low grade brain swelling and disturbances of the chemical balance within the brain, resulting in functional impairment, the presence of which MR imaging can detect with sufficient sensitivity to monitor the changes that may occur over time in response to treatment.
Detailed description
Hepatic encephalopathy (HE) is a common neuropsychiatric abnormality, complicating the course of liver disease patients. In the UK, cirrhosis accounts for 4000 deaths per year, and 500,000 people are thought to be infected with chronic hepatitis C, of which up to 20% will develop cirrhosis over 20 years. The condition has been difficult to monitor objectively.
Despite the fact that the syndrome was probably first recognised two thousand years ago, the exact pathogenesis still remains unclear. It is thought to represent a reversible disturbance in brain chemistry and consequent brain swelling, in response to blood containing unfiltered gut-derived toxins entering the cerebral circulation. There is no recognised 'gold standard' test to diagnose and monitor this important, disabling condition. I have developed a novel combination of magnetic resonance imaging (MRI) sequences at 3 Tesla to study the effects of hepatic encephalopathy on the brain in patients with cirrhosis.
We propose to investigate alterations in brain size, function and chemistry before, and then at intervals after 4 weeks anti-encephalopathy treatment with L-ornithine L-aspartate. This will enable the assessment of both the baseline brain alterations of the cohort and the brain's response to therapy and correlation with their clinical response. As such this longitudinal study would allow us to define the sensitivity of the MR techniques.
Each of 50 patients will have blood tests, a 1 hour MRI brain scan and psychometric testing. The psychometric testing will be performed with both a computer-based battery and conventional paer-based tests. They will then be given L-ornithine L-aspartate (LOLA) to take orally for 4 weeks and have repeat blood tests, MRI and psychometric tests.
We will then determine if there is a correlation between the MR data and the results of the psychometric testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65
- Biopsy-proven cirrhosis
- Clinically stable
- Able to give informed consent
- Fluent English (required for psychometric testing)
Key exclusion criteria (6 listed)
- Ferro-magnetic implants
- Claustrophobia
- Weight >120kg
- Significant renal impairment (Creatinine >150 micromol/L)
- Poorly controlled Diabetes (particularly type I with microvascular complications)
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 |
|---|---|---|
| l-ornithine l-aspartate | Drug | – |
Primary outcome
All enrolled patients will be given 4 weeks of treatment. Both MRI and functional changes will be observed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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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.
Simon D Taylor-Robinson, MBBS, FRCP principal investigator
Imperial College London & St Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing l-ornithine l-aspartate in people with Cirrhosis and Hepatic Encephalopathy, run by Imperial College London at 1 site in United Kingdom.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 May 2015. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
All enrolled patients will be given 4 weeks of treatment. Both MRI and functional changes will be observed.. It is what the study was designed to measure, not a finding.
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 29 May 2015.