Chronic Liver DiseaseFALLNCT05335603
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
An observational study of Chronic Liver Disease, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 335 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Aug 2020to Aug 2036
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potentially eligible patients will be identified and recruited among those referred with suspected liver disease at the outpatient clinic at the Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark. Healthy control participants will be recruited through advertisements at forsoegsperson.dk and posters. Posters will be mounted in neutral places at Copenhagen University Hospital Hvidovre and at neutral places at the Panum Institute. Copenhagen University Hospital Hvidovre is a large regional hospital with more than 3500 employees and the Panum Institute is a large building complex in Copenhagen, Denmark that houses the Faculty of Health and Medical Sciences.
Who may be able to join
- Adult patients/healthy control participants (age 18 or above) who can give their informed consent
- Suspected liver disease:
- non-alcoholic steatohepatitis
- alcoholic steatohepatitis
- autoimmune hepatitis
- primary biliary cholangitis
Show all 13Show fewer
- primary sclerosing cholangitis
- inflammatory bowel disease
- polycystic ovary syndrome
- hereditary haemochromatosis
- chronic pancreatitis
- cystic fibrosis
- alpha-1 antitrypsin deficiency
Who cannot join
- Patients with:
- malignant diseases
- viral hepatitis
- human immunodeficiency virus
- contraindications to liver biopsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, 2650
Anne-Sofie H Jensen, MD, +4538621966, anne-sofie.houlberg.jensen@regionh.dk
Lise L Gluud, Professor, +4538621964, lise.lotte.gluud.01@regionh.dk
About this study
Official title: Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.
- Conditions
- Chronic Liver Disease
- Keywords
- non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, steatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alfa-1-antitrypsin deficiency, chronic pancreatitis, chronic liver disease, inflammatory bowel disease, OMICS, Mass spectrometry
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Hepatitis, Autoimmune, Liver Cirrhosis, Biliary, Cholangitis, Sclerosing, Hemochromatosis, Pancreatitis, Chronic, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.
OMICS based analyses on plasma and liver tissue
Measured: 10 years
Secondary outcomes (1)
To identify any metabolic disturbances within chronic liver diseases
Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones
Measured: Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start24 Aug 2020
- Primary completionAug 2036 (estimated)
- Study completionAug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 CopenhagenThe 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
- 335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Nicolai Jacob Wewer Albrechtsen, University of Copenhagen
- Investigators
- Lise L Gluud, Professor, Principal investigator, Hvidovre University HospitalNicolai J Wewer Albrechtsen, MD, PhD, Principal investigator, NNF Center for Protein Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335603
- Sponsor's protocol ID
- FALL
- Acronym
- FALL
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jensen AH, Ytting H, Nielsen AB, Werge MP, Rashu EB, Hetland LE, Thing M, Nabilou P, Burisch J, Junker AE, Hobolth L, Mortensen C, Tofteng F, Bendtsen F, Moller S, Vyberg M, Serizawa RR, Winther-Sorensen M, Kellemann JS, Gluud LL, Wewer Albrechtsen NJ. Diagnostics of Autoimmune Hepatitis Enabled by Non-Invasive Clinical Proteomics. Aliment Pharmacol Ther. 2025 Nov;62(9):901-919. doi: 10.1111/apt.70273. Epub 2025 Jul 17.
PubMed 40671462
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT05335603
- Acronym / sponsor ID
- FALL / FALL
- Conditions
- Chronic Liver Disease
- Keywords
- non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, steatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alfa-1-antitrypsin deficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- Aug 2036 (estimated)
- Study completion
- Aug 2036 (estimated)
- First posted
- 19 Apr 2022 (actual)
- 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 steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potentially eligible patients will be identified and recruited among those referred with suspected liver disease at the outpatient clinic at the Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark. Healthy control participants will be recruited through advertisements at forsoegsperson.dk and posters. Posters will be mounted in neutral places at Copenhagen University Hospital Hvidovre and at neutral places at the Panum Institute. Copenhagen University Hospital Hvidovre is a large regional hospital with more than 3500 employees and the Panum Institute is a large building complex in Copenhagen, Denmark that houses the Faculty of Health and Medical Sciences.
Key inclusion criteria (13 listed)
- Adult patients/healthy control participants (age 18 or above) who can give their informed consent
- Suspected liver disease:
- non-alcoholic steatohepatitis
- alcoholic steatohepatitis
- autoimmune hepatitis
Key exclusion criteria (5 listed)
- malignant diseases
- viral hepatitis
- human immunodeficiency virus
- contraindications to liver biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.
Time frame: 10 years
OMICS based analyses on plasma and liver tissue
1 secondary outcome
To identify any metabolic disturbances within chronic liver diseases
Time frame: Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.
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 19 Apr 2022.
- Derived from this study: PubMed 40671462Jensen AH, Ytting H, Nielsen AB, Werge MP, Rashu EB, Hetland LE, Thing M, Nabilou P, Burisch J, Junker AE, Hobolth L, Mortensen C, Tofteng F, Bendtsen F, Moller S, Vyberg M, Serizawa RR, Winther-Sorensen M, Kellemann JS, Gluud LL, Wewer Albrechtsen NJ. Diagnostics of Autoimmune Hepatitis Enabled by Non-Invasive Clinical Proteomics. Aliment Pharmacol Ther. 2025 Nov;62(9):901-919. doi: 10.1111/apt.70273. Epub 2025 Jul 17.
- Individual participant dataSharing planned: Undecided
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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.
Lise L Gluud, Professor principal investigator
Hvidovre University Hospital
Nicolai J Wewer Albrechtsen, MD, PhD principal investigator
NNF Center for Protein Research
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, run by University of Copenhagen at 1 site in Denmark.
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 13 inclusion and 5 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 19 Apr 2022. 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 Denmark. 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?
Contact Anne-Sofie H Jensen, MD (+4538621966, anne-sofie.houlberg.jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases. (time frame: 10 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 NCT05335603, which also lists 1 linked publication.
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 19 Apr 2022.