NAFLDNCT01281059
Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test
A study testing BreathID - Breath Test - 13C Octanoate in people with NAFLD, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of the study is to demonstrate that the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD
- What is being tested?
- BreathID - Breath Test - 13C Octanoate
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women (>18 years of age)
- Liver -biopsy ( at least 1.7 cm and 4 portal tracts) performed within 6 months of breath test or planned within the next 6 weeks, providing no treatment for liver disease was given between the biopsy and the OBT Any elevation of liver enzymes above the upper limit of normal (any or all of the following: AST,ALT, GGT, Alkaline phosphatase)
- At least one of the features of the metabolic syndrome
- waist circumference > 100 cm for men, 88 cm for women
- triglycerides > 150 mg/dl
- fasting blood sugar > 110 mg/dl
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- HDL cholesterol < 40 mg/dl
- blood pressure > 130/85 mm Hg
- No other known co-existent liver disease, excluded by appropriate serologic testing
Who cannot join
- Positive studies for any of the following:
- hepatitis C (PCR)
- hepatitis B (surface antigen or DNA)
- iron saturation > 60% + gene test for hereditary hemochromatosis
- antinuclear antibody at a titer > 1: 160 along with hypergammaglobulinemia and ALT levels>250 U/L
- Patient has Alpha-1-antitrypsin level below lower limit of normal (< 150 mg/dl)
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- Patient has alcohol consumption > 20 gm/day for women and > 30 gm/day for men
- Patient is pregnant
- Patient has been taking known hepatotoxic drugs e.g. (e.g.acebutolol, indomethacin,phenylbutazone,allopurinol,isoniazid,phenytoin,atenolol,ketoconazole,piroxicam,carbamazepine,labetalol,probenecid,cimetidine,maprotiline,pyrazinamide,dantrolene, metoprolol,quinidine,diclofenac, mianserin)• Patients that have had more than 10% reduction in body weight since biopsy
- Patient with known severe congestive heart failure (LVEF on echocardiogram < 20%)
- Patient with known severe pulmonary hypertension (By echocardiogram, PAS >45 mmHg)
- Patient with uncontrolled diabetes mellitus (HA1c>10)
- Patient with previous surgical bypass surgery
- Patient with extensive short bowel syndrome(>100 cm)
- Patient currently receiving total parenteral nutrition
- Patient is a recipients of any organ transplant
- Patients that received any anti-viral treatment or any other liver therapy between the time of the biopsy and the breath test.
- Women who are pregnant
- Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
- Patient has taken drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine.
- Patients unable or refuse to sign informed consent
- Patients that based on the opinion of the investigator should not be enrolled into this study
- Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Trial locations and contacts
1 site in 1 country.
About this study
The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting non alcoholic steatohepatitis(NASH) with a high probability.
Retrospective analysis based on multivariable analysis will determined if and which demographic, clinical and biochemical or imaging techniques data can assist in addition to the data derived from OBT in differentiation of NASH, NAFL and possibly normals.
- Conditions
- NAFLD
- Being tested
- BreathID - Breath Test - 13C Octanoate
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreathID - Breath Test - 13C OctanoateDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Meridian Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281059
- Sponsor's protocol ID
- 0429-10-HMO-CTIL
- Status last verified
- Aug 2011
- First submitted
- 10 Jan 2011
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test
- ClinicalTrials.gov ID
- NCT01281059
- Acronym / sponsor ID
- 0429-10-HMO-CTIL
- Conditions
- NAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Meridian Bioscience, Inc.
- Study start
- Jan 2011
- First posted
- 21 Jan 2011 (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.
The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting non alcoholic steatohepatitis(NASH) with a high probability.
Retrospective analysis based on multivariable analysis will determined if and which demographic, clinical and biochemical or imaging techniques data can assist in addition to the data derived from OBT in differentiation of NASH, NAFL and possibly normals.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult men or women (>18 years of age)
- Liver -biopsy ( at least 1.7 cm and 4 portal tracts) performed within 6 months of breath test or planned within the next 6 weeks, providing no treatment for liver disease was given between the biopsy and the OBT Any elevation of liver enzymes above the upper limit of normal (any or all of the following: AST,ALT, GGT, Alkaline phosphatase)
- At least one of the features of the metabolic syndrome
- No other known co-existent liver disease, excluded by appropriate serologic testing
Key exclusion criteria (23 listed)
- Positive studies for any of the following:
- hepatitis C (PCR)
- hepatitis B (surface antigen or DNA)
- iron saturation > 60% + gene test for hereditary hemochromatosis
- antinuclear antibody at a titer > 1: 160 along with hypergammaglobulinemia and ALT levels>250 U/L
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 |
|---|---|---|
| BreathID - Breath Test - 13C Octanoate | Device | – |
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 28 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BreathID - Breath Test - 13C Octanoate in people with NAFLD, run by Hadassah Medical Organization at 1 site in Israel.
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 9 inclusion and 23 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 28 Aug 2012. 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 Israel. 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 28 Aug 2012.