Chronic Liver DiseaseNCT02037867
Nottingham Community Liver Biomarkers Cohort
An observational study of Chronic Liver Disease and Alcohol Use Disorder, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver disease is now the 3rd leading cause of premature death in the United Kingdom. The majority of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes, injecting drug use) and therefore reversible if… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Alcohol Use Disorder, Type 2 Diabetes
- What is being tested?
- Fibrosis Biomarkers
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to May 2033
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A Primary Care database search (Systmone, TPP)will be performed to identify patients eligible for study (see inclusion criteria) in the discrete patient populations.
Who may be able to join
- Adult patients aged 18 years or over (male or female) with primary risk factor for liver disease:
- Hazardous alcohol use (>14 units/week for women, >21 units/week for men)
- Type 2 Diabetes
- Obesity
- Persistently elevated ALT with normal liver serology
Who cannot join
- Active malignancy at study enrolment
- Inability to provide informed consent for study enrolment
- Known presence of histologically proven liver disease prior to pilot pathway participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR Nottingham Digestive Diseases Biomedical Research Unit
Nottingham, Notts, NG7 2UH
Neil Guha, MRCP, PhD, 01159249924 ext. 70609, neil.guha@nottingham.ac.uk
Rebecca Harris, BMedSci, BMBS, 01159249924 ext. 70616, rebecca.harris@nottingham.ac.uk
About this study
Official title: The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers
Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver disease is now the 3rd leading cause of premature death in the United Kingdom. The majority of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes, injecting drug use) and therefore reversible if caught at a precirrhosis stage. However, current liver function blood tests are poor inadequate, and subsequently a large burden of liver disease is currently missed.
A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which identify liver disease accurately at earlier stages of scarring. The identification of liver disease in the community, where previous studies have discovered a large burden of previously unidentified but significant liver disease, is therefore a feasible place to develop new liver disease investigation pathways using these noninvasive markers.
Read more
In collaboration with the Department of Health, Nottingham University Hospitals have commenced a pilot community liver disease pathway in two General Practices in Nottingham in February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2 diabetes)are invited to take part in the pathway. Patients undergo a simple blood test (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary findings show that the pathway accurately identifies patients with early liver scarring and previously unidentified significant liver disease. The participating General Practitioners have also noted a striking number of patients finally engaging in important lifestyle changes following pathway implementation. A second phase of the pilot pathway, in 2 Inner City General Practices with a total practice population of c.14,000 patients commenced in June 2013.
We have subsequently designed this cohort study, where pilot participants will be consented for follow up over a long period. We will assess future liver-related and cardiovascular events (including death), and perform qualitative patient interviews to assess the reasons for and persistence of lifestyle changes after liver disease investigation. We hypothesize that stratification of liver disease in the community will unearth a significant amount of previously undetected but significant chronic liver disease. Moreover, we will evaluate whether stratification of liver disease using these tests predicts future liver and cardiovascular disease and death, and whether stratification has an impact on patient's future lifestyle choices.
Read the detailed description
Objectives:
- To establish a community based cohort with risk factors for liver disease and stratification for liver disease severity using non-invasive biomarkers.
- To establish the incidence of liver and cardiovascular morbidity and mortality in a community cohort.
- To explore the quantitative and qualitative indicators to potential alterations in patient lifestyle following stratification of liver disease to inform future intervention development.
- To evaluate novel blood markers of liver fibrosis and cirrhosis on a large cohort of primary care patients
Study Configuration:
Longitudinal Cohort Study with long-term follow up
Setting:
Primary Care, Nottingham
Number of Participants:
Prospective and consecutive recruitment in the East Midlands - approximately 500 patients per annum over a 4 year cohort inception period. Total anticipated cohort size 2,000 participants.
Description of Interventions:
- Serum blood sampling (AST:ALT ratio, and serum stored for future liver biomarker development)
- Transient Elastography (Fibroscan)
- Qualitative Interviews (limited to approximately 30 patients)
- Consent to longitudinal data follow-up and approach for future lifestyle intervention trials - consenting patients will be tagged on MRIS database.
Duration of Study:
48 month cohort inception with long term longitudinal follow up of cardiovascular and liver related outcomes and mortality data.
Outcome Measures:
- Incidence of liver (cirrhosis) and cardiovascular disease (symptomatic coronary or cerebrovascular disease).
- All cause morbidity and mortality.
- Quantitative and qualitative lifestyle measures (including body mass index, exercise levels, alcohol consumption).
Patients who decide to participate in the community cohort will not be required to perform any specific actions or attend study visits (unless for the reasons stated below). Usual clinical care (both liver-related and non-liver related) will continue during the study period.
Patients will consent to long term longitudinal data follow-up using the Medical Research Information Service (MRIS) database. All patients enrolled in the community cohort will be prospectively tagged on MRIS. In particular, the investigators will request individual patient alerts on MRIS concerning prevalent cardiovascular disease events (angina, myocardial infarction and stroke), liver cirrhosis and cause of death.
Patients will consent to undertake qualitative research to evaluate the process of community stratification. A purposeful sample of patients completing the community biomarkers pathway will be invited to participate in qualitative follow up of their experiences of the pathway and any subsequent lifestyle change. A researcher, trained in qualitative research methods, will perform a semi-structured interview, which will assess any lifestyle changes occurring following liver pathway stratification. Specifically, changes in alcohol consumption, diet and exercise will be explored and evaluated, with assessment of the relationship to liver pathway stratification (both investigation results and lifestyle advice offered during the pathway). Interviews will performed either face-to-face, in which case this will be performed at the Nottingham Digestive Diseases Biomedical Research Unit, or over the telephone - in all cases voice recording will occur to allow analysis of information provided. An example interview proforma to be utilized for these qualitative interviews has been provided separately.
Patients will be consented to donate biosamples (including blood and urine) to the Nottingham Health Sciences Biobank on inception into the cohort. An appointment will be made at the NIHR Nottingham Digestive Diseases Biomedical Research Unit for witnessed written consent and to allow donation of biosamples. Samples will be collected by trained research nurses, who also form part of the research team. These biosamples will be utilized for future research into novel biomarkers of liver and cardiovascular disease, including proteomics and metabonomics. Where participants do not agree to the future use of the samples they will be destroyed in accordance with the Human Tissue Act, 2004.
In the future, the investigators will plan trials assessing novel exercise and dietary interventions, and subsequent effects on patient lifestyle parameters and future cardiovascular risk. Patients forming the community cohort will consent for contact regarding these future trials; however individual trials will be subject to their own ethical approval and written consent.
- Conditions
- Chronic Liver Disease, Alcohol Use Disorder, Type 2 Diabetes, Persistently Elevated ALT, Obesity
- Being tested
- Fibrosis Biomarkers
- Keywords
- alcohol, type 2 diabetes, ALT, abnormal liver enzymes, hepatic fibrosis, cirrhosis
- Medical subject headings
- Alcoholism, Diabetes Mellitus, Type 2, Obesity, Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrosis BiomarkersDevice
Also called AST:ALT ratio, APRI, BARD score, ELF Score, FIB4, NAFLD Fibrosis Score,Transient Elastography
Liver disease stratification with liver stiffness scan (Transient Elastography) Analysis of diagnostic performance of serum fibrosis markers (as listed above) Whole blood samples obtained for DNA analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients identified with one of the below chronic liver disease risk factors and undergoing community liver disease stratification using fibrosis biomarkers:
* Hazardous alcohol use (>14 units per week in females, >21 units per week in males, alcohol AUDIT score >=8 or read code relevant to alcohol abuse on GP system)
* Type 2 Diabetes
* Obesity
* Persistently raised serum ALT level, negative liver serology, and absence of above 2 risk factors Receives: Device: Fibrosis Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver and cardiovascular-related mortality
Death recorded as resulting from cardiovascular or liver-related causes
Measured: 20 years
Secondary outcomes (3)
Liver Cirrhosis
Incidence of compensated and decompensated cirrhosis diagnosis during the study period.
Measured: 20 years
Cardiovascular Disease
Incidence of cardiovascular disease events(defined as symptomatic coronary or cerebrovascular disease)during the study period.
Measured: 20 years
All-cause mortality
Recording of any death during the study period
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2033 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Guha, MRCP, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037867
- Sponsor's protocol ID
- 13029
- Other IDs
- 13/EM/0123
- Status last verified
- Feb 2019
- First submitted
- 14 Jan 2014
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradley CR, Cox EF, Palaniyappan N, Aithal GP, Francis ST, Guha IN. Variability of noninvasive MRI and biological markers in compensated cirrhosis: insights for assessing disease progression. Eur Radiol Exp. 2022 Oct 24;6(1):52. doi: 10.1186/s41747-022-00303-y.
PubMed 36274113Tanajewski L, Harris R, Harman DJ, Aithal GP, Card TR, Gkountouras G, Berdunov V, Guha IN, Elliott RA. Economic evaluation of a community-based diagnostic pathway to stratify adults for non-alcoholic fatty liver disease: a Markov model informed by a feasibility study. BMJ Open. 2017 Jul 5;7(6):e015659. doi: 10.1136/bmjopen-2016-015659.
PubMed 28679676Harman DJ, Ryder SD, James MW, Jelpke M, Ottey DS, Wilkes EA, Card TR, Aithal GP, Guha IN. Direct targeting of risk factors significantly increases the detection of liver cirrhosis in primary care: a cross-sectional diagnostic study utilising transient elastography. BMJ Open. 2015 May 3;5(4):e007516. doi: 10.1136/bmjopen-2014-007516.
PubMed 25941185
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers
- ClinicalTrials.gov ID
- NCT02037867
- Acronym / sponsor ID
- 13029
- Conditions
- Chronic Liver Disease, Alcohol Use Disorder, Type 2 Diabetes, Persistently Elevated ALT, Obesity
- Keywords
- alcohol, type 2 diabetes, ALT, abnormal liver enzymes, hepatic fibrosis, cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2033 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 16 Jan 2014 (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.
Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver disease is now the 3rd leading cause of premature death in the United Kingdom. The majority of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes, injecting drug use) and therefore reversible if caught at a precirrhosis stage. However, current liver function blood tests are poor inadequate, and subsequently a large burden of liver disease is currently missed.
A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which identify liver disease accurately at earlier stages of scarring. The identification of liver disease in the community, where previous studies have discovered a large burden of previously unidentified but significant liver disease, is therefore a feasible place to develop new liver disease investigation pathways using these noninvasive markers.
In collaboration with the Department of Health, Nottingham University Hospitals have commenced a pilot community liver disease pathway in two General Practices in Nottingham in February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2 diabetes)are invited to take part in the pathway. Patients undergo a simple blood test (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary findings show that the pathway accurately identifies patients with early liver scarring and previously unidentified significant liver disease. The participating General Practitioners have also noted a striking number of patients finally engaging in important lifestyle changes following pathway implementation. A second phase of the pilot pathway, in 2 Inner City General Practices with a total practice population of c.14,000 patients commenced in June 2013.
We have subsequently designed this cohort study, where pilot participants will be consented for follow up over a long period. We will assess future liver-related and cardiovascular events (including death), and perform qualitative patient interviews to assess the reasons for and persistence of lifestyle changes after liver disease investigation. We hypothesize that stratification of liver disease in the community will unearth a significant amount of previously undetected but significant chronic liver disease. Moreover, we will evaluate whether stratification of liver disease using these tests predicts future liver and cardiovascular disease and death, and whether stratification has an impact on patient's future lifestyle choices.
Detailed description
Objectives:
- To establish a community based cohort with risk factors for liver disease and stratification for liver disease severity using non-invasive biomarkers.
- To establish the incidence of liver and cardiovascular morbidity and mortality in a community cohort.
- To explore the quantitative and qualitative indicators to potential alterations in patient lifestyle following stratification of liver disease to inform future intervention development.
- To evaluate novel blood markers of liver fibrosis and cirrhosis on a large cohort of primary care patients
Study Configuration:
Longitudinal Cohort Study with long-term follow up
Setting:
Primary Care, Nottingham
Number of Participants:
Prospective and consecutive recruitment in the East Midlands - approximately 500 patients per annum over a 4 year cohort inception period. Total anticipated cohort size 2,000 participants.
Description of Interventions:
- Serum blood sampling (AST:ALT ratio, and serum stored for future liver biomarker development)
- Transient Elastography (Fibroscan)
- Qualitative Interviews (limited to approximately 30 patients)
- Consent to longitudinal data follow-up and approach for future lifestyle intervention trials - consenting patients will be tagged on MRIS database.
Duration of Study:
48 month cohort inception with long term longitudinal follow up of cardiovascular and liver related outcomes and mortality data.
Outcome Measures:
- Incidence of liver (cirrhosis) and cardiovascular disease (symptomatic coronary or cerebrovascular disease).
- All cause morbidity and mortality.
- Quantitative and qualitative lifestyle measures (including body mass index, exercise levels, alcohol consumption).
Patients who decide to participate in the community cohort will not be required to perform any specific actions or attend study visits (unless for the reasons stated below). Usual clinical care (both liver-related and non-liver related) will continue during the study period.
Patients will consent to long term longitudinal data follow-up using the Medical Research Information Service (MRIS) database. All patients enrolled in the community cohort will be prospectively tagged on MRIS. In particular, the investigators will request individual patient alerts on MRIS concerning prevalent cardiovascular disease events (angina, myocardial infarction and stroke), liver cirrhosis and cause of death.
Patients will consent to undertake qualitative research to evaluate the process of community stratification. A purposeful sample of patients completing the community biomarkers pathway will be invited to participate in qualitative follow up of their experiences of the pathway and any subsequent lifestyle change. A researcher, trained in qualitative research methods, will perform a semi-structured interview, which will assess any lifestyle changes occurring following liver pathway stratification. Specifically, changes in alcohol consumption, diet and exercise will be explored and evaluated, with assessment of the relationship to liver pathway stratification (both investigation results and lifestyle advice offered during the pathway). Interviews will performed either face-to-face, in which case this will be performed at the Nottingham Digestive Diseases Biomedical Research Unit, or over the telephone - in all cases voice recording will occur to allow analysis of information provided. An example interview proforma to be utilized for these qualitative interviews has been provided separately.
Patients will be consented to donate biosamples (including blood and urine) to the Nottingham Health Sciences Biobank on inception into the cohort. An appointment will be made at the NIHR Nottingham Digestive Diseases Biomedical Research Unit for witnessed written consent and to allow donation of biosamples. Samples will be collected by trained research nurses, who also form part of the research team. These biosamples will be utilized for future research into novel biomarkers of liver and cardiovascular disease, including proteomics and metabonomics. Where participants do not agree to the future use of the samples they will be destroyed in accordance with the Human Tissue Act, 2004.
In the future, the investigators will plan trials assessing novel exercise and dietary interventions, and subsequent effects on patient lifestyle parameters and future cardiovascular risk. Patients forming the community cohort will consent for contact regarding these future trials; however individual trials will be subject to their own ethical approval and written consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Fibrosis BiomarkersPatients identified with one of the below chronic liver disease risk factors and undergoing community liver disease stratification using fibrosis biomarkers: * Hazardous alcohol use (>14 units per week in females, >21 units per week in males, alcohol AUDIT score >=8 or read code relevant to alcohol abuse on GP system) * Type 2 Diabetes * Obesity * Persistently raised serum ALT level, negative liver serology, and absence of above 2 risk factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A Primary Care database search (Systmone, TPP)will be performed to identify patients eligible for study (see inclusion criteria) in the discrete patient populations.
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or over (male or female) with primary risk factor for liver disease:
Key exclusion criteria (3 listed)
- Active malignancy at study enrolment
- Inability to provide informed consent for study enrolment
- Known presence of histologically proven liver disease prior to pilot pathway participation
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 |
|---|---|---|
| Fibrosis BiomarkersAlso: AST:ALT ratio, APRI, BARD score, ELF Score, FIB4, NAFLD Fibrosis Score,Transient ElastographyLiver disease stratification with liver stiffness scan (Transient Elastography) Analysis of diagnostic performance of serum fibrosis markers (as listed above) Whole blood samples obtained for DNA analysis | Device | Patients |
Primary outcome
Liver and cardiovascular-related mortality
Time frame: 20 years
Death recorded as resulting from cardiovascular or liver-related causes
3 secondary outcomes
Liver Cirrhosis
Time frame: 20 years
Cardiovascular Disease
Time frame: 20 years
All-cause mortality
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 36274113Bradley CR, Cox EF, Palaniyappan N, Aithal GP, Francis ST, Guha IN. Variability of noninvasive MRI and biological markers in compensated cirrhosis: insights for assessing disease progression. Eur Radiol Exp. 2022 Oct 24;6(1):52. doi: 10.1186/s41747-022-00303-y.
- Derived from this study: PubMed 28679676Tanajewski L, Harris R, Harman DJ, Aithal GP, Card TR, Gkountouras G, Berdunov V, Guha IN, Elliott RA. Economic evaluation of a community-based diagnostic pathway to stratify adults for non-alcoholic fatty liver disease: a Markov model informed by a feasibility study. BMJ Open. 2017 Jul 5;7(6):e015659. doi: 10.1136/bmjopen-2016-015659.
- Derived from this study: PubMed 25941185Harman DJ, Ryder SD, James MW, Jelpke M, Ottey DS, Wilkes EA, Card TR, Aithal GP, Guha IN. Direct targeting of risk factors significantly increases the detection of liver cirrhosis in primary care: a cross-sectional diagnostic study utilising transient elastography. BMJ Open. 2015 May 3;5(4):e007516. doi: 10.1136/bmjopen-2014-007516.
- Nottingham Digestive Disease Biomedical Research UnitLink provided by the sponsor.
Related trials for Chronic Liver Disease
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Recruiting
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Liver Diseases
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.
NIHR Nottingham Digestive Diseases Biomedical Research Unit
Nottingham, United Kingdom
Neil Guha, MRCP, PhD principal investigator
University of Nottingham
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 Chronic Liver Disease and Alcohol Use Disorder, run by University of Nottingham 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 3 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: looking for participants now, as of the sponsor's last update on 8 Feb 2019. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver and cardiovascular-related mortality (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037867, which also lists 3 linked publications.
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 8 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.