Elevated Liver EnzymesNCT01784484
Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes
An observational study of Elevated Liver Enzymes, run by Assy Nimer at 1 site in Israel.
Trial summary
BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Liver Enzymes
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Jan 2014
- Phase
- Observational
- 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
Study population: Patients with abnormal liver enzymnes who attend the liver clinic
Who may be able to join
- Male or female subjects
- More than 18 years of age
- Patients with elevated liver enzymes
- Written informed consent
Who cannot join
- Patients refusing to participate to the study and to provide written informed consent
- clotting disorder
- ongoing treatment with anti-coagulant or anti-aggregant
- advanced or decompensated cirrhosis (Child-Pugh class C)
- hepatocellular carcinoma
- other cancer
Show all 9Show fewer
- history of surgery for brain aneurysm
- pace maker or defibrillator
- ocular metal foreign body
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv Medical Center
Safed, Israel, 13100
Nimer Assy, MD, +972-4-6828442, assy.n@ziv.health.gov.il
About this study
BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values will emerge as the most important independent predictive variable of fibrosis and not serum ALT. A significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with NAFLD.
- Conditions
- Elevated Liver Enzymes
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| patients with abnormal liver enzymnes | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver stiffness
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Liver EnzymesStudies 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Assy Nimer
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Assy Nimer, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784484
- Sponsor's protocol ID
- 0058-12-ZIV
- Status last verified
- Feb 2013
- First submitted
- 23 Jan 2013
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes
- ClinicalTrials.gov ID
- NCT01784484
- Acronym / sponsor ID
- 0058-12-ZIV
- Conditions
- Elevated Liver Enzymes
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Assy NimerOther government
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 5 Feb 2013 (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.
BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values will emerge as the most important independent predictive variable of fibrosis and not serum ALT. A significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with NAFLD.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with abnormal liver enzymnes | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abnormal liver enzymnes who attend the liver clinic
Key inclusion criteria (4 listed)
- Male or female subjects
- More than 18 years of age
- Patients with elevated liver enzymes
- Written informed consent
Key exclusion criteria (9 listed)
- Patients refusing to participate to the study and to provide written informed consent
- clotting disorder
- ongoing treatment with anti-coagulant or anti-aggregant
- advanced or decompensated cirrhosis (Child-Pugh class C)
- hepatocellular carcinoma
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 |
|---|---|---|
| No intervention | Other | patients with abnormal liver enzymnes |
Primary outcome
liver stiffness
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Liver Enzymes, run by Assy Nimer 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 4 inclusion and 9 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 5 Feb 2013. 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?
Contact Nimer Assy, MD (+972-4-6828442, assy.n@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver stiffness (time frame: one year). 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 5 Feb 2013.