Chronic Liver DiseaseNCT04943978
Prospective Studies on Immunopathogenesis of Liver Fibrosis
An observational study of Chronic Liver Disease, run by University of Regensburg at 1 site in Germany.
Trial summary
The immune system is thought to play a key role in the development of liver inflammation and subsequent liver fibrosis or cirrhosis. In the case of viral hepatitis and autoimmune hepatitis, for example, numerous studies have focused on the acquired antigen-specific immunity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2014to 31 Jan 2026
- 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 chronic or acute liver disease undergoing surgery.
Who may be able to join
- Patients with chronic liver disease up to progressive cirrhosis (e.g. ethyltoxic, Viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC).
- Patients with elevated liver values undergoing elective abdominal surgery.
- As comparison groups patients with acute hepatitis (e.g. viral or autoimmune genesis) and patients without liver disease.
Who cannot join
- Age under 18
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Surgery, University Hospital Regensburg
Regensburg, Bavaria, 93053
Jens M. Werner, MD, +49941944 ext. 16808, jens.werner@ukr.de
About this study
Official title: Prospective Studies on the Immunopathogenesis of Fibrosis in Acute and Chronic Liver Diseases
The immune system is thought to play a key role in the development of liver inflammation and subsequent liver fibrosis or cirrhosis.
In the case of viral hepatitis and autoimmune hepatitis, for example, numerous studies have focused on the acquired antigen-specific immunity. However, the liver is the site of increased occurrence of the components of the innate immune response (NK and NKT cells) and, in contrast to T cells, these T cells, these do not require antigen presentation.
Read more
Therefore, the present study was designed to determine which cellular components of the (NK, NKT, dendritic cells, macrophages) or the acquired immune response (CD4, CD8) or which network of immune cells is involved in the immunopathogenesis of progressive liver inflammation or the development of liver fibrosis.
The aim is to identify lymphocyte populations that exhibit either prognostically favorable or unfavorable characteristics. This should allow conclusions to be drawn for a more targeted and individualized therapy of the respective chronic liver diseases.
Read the detailed description
In patients with acute liver inflammation (e.g., autoimmune hepatitis, viral hepatitis) or chronic inflammation (e.g., ethyltoxic, viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC) or liver fibrosis, the cellular immune response will be prospectively investigated and compared with liver healthy control patients.
For this purpose, patients with known or unknown liver disease will be tested during inpatient stays or during a visit to the outpatient clinic after written consent has been obtained.
Blood is then processed for further immunological cell analyses and finally frozen in liquid nitrogen. If a liver biopsy is taken from the patient as part of the clinical diagnostics during an inpatient stay or if a liver biopsy or liver resection is performed during a procedure in the OR, tissue that is not required for diagnostic purposes should be frozen for further immunological cell analysis.
If patients undergoing elective surgery in the abdominal cavity are suspected of having a liver disease (e.g., altered liver parameters in the blood) and a wedge biopsy of the liver will be performed intraoperatively for diagnostics, tissue that is not required for diagnostic purposes should be prepared for further immunological cell analysis.
In addition, a part of the liver tissue obtained should be preserved for later genetic studies, e.g. in RNA-later.
In case of acute liver disease, further blood samples should be taken 48 and 96 h later and on weeks 1, 2, 4, 6, and 12, and after 6 and 12 months, respectively (or at the respective visits to the outpatient clinic).
For patients with chronic liver disease, blood should be re-collected during their regular visits at the outpatient clinic
In addition to patient history and medical information, the patients should also be regularly examined during the entire duration of the study and medical information, that are regularly collected during routine laboratory work ups (e.g. viral titers by quantitative PCR, liver enzymes and liver function) will be included.
To compare the immune responses, lymphocytes from patients without liver disease will be examined. will be investigated. Furthermore, healthy blood donors will be used as an additional control group.
- Conditions
- Chronic Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Also called No Intervention
just observational blood and liver sampling
| Study group | Role | What they receive |
|---|---|---|
| Liver disease | Patients with either acute or chronic liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fibrosis
Stage of liver fibrosis in histology (Ishak-score (1 - 6))
Measured: Day 0
Liver Steatosis
Stage of liver steatosis in histology (NASH activity score (1 - 8))
Measured: Day 0
Secondary outcomes (1)
Survival
Overall Survival
Measured: After 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Feb 2014
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Geissler, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943978
- Sponsor's protocol ID
- 13-257-101
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on data safety plan
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Studies on the Immunopathogenesis of Fibrosis in Acute and Chronic Liver Diseases
- ClinicalTrials.gov ID
- NCT04943978
- Acronym / sponsor ID
- 13-257-101
- Conditions
- Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 29 Jun 2021 (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.
The immune system is thought to play a key role in the development of liver inflammation and subsequent liver fibrosis or cirrhosis.
In the case of viral hepatitis and autoimmune hepatitis, for example, numerous studies have focused on the acquired antigen-specific immunity. However, the liver is the site of increased occurrence of the components of the innate immune response (NK and NKT cells) and, in contrast to T cells, these T cells, these do not require antigen presentation.
Therefore, the present study was designed to determine which cellular components of the (NK, NKT, dendritic cells, macrophages) or the acquired immune response (CD4, CD8) or which network of immune cells is involved in the immunopathogenesis of progressive liver inflammation or the development of liver fibrosis.
The aim is to identify lymphocyte populations that exhibit either prognostically favorable or unfavorable characteristics. This should allow conclusions to be drawn for a more targeted and individualized therapy of the respective chronic liver diseases.
Detailed description
In patients with acute liver inflammation (e.g., autoimmune hepatitis, viral hepatitis) or chronic inflammation (e.g., ethyltoxic, viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC) or liver fibrosis, the cellular immune response will be prospectively investigated and compared with liver healthy control patients.
For this purpose, patients with known or unknown liver disease will be tested during inpatient stays or during a visit to the outpatient clinic after written consent has been obtained.
Blood is then processed for further immunological cell analyses and finally frozen in liquid nitrogen. If a liver biopsy is taken from the patient as part of the clinical diagnostics during an inpatient stay or if a liver biopsy or liver resection is performed during a procedure in the OR, tissue that is not required for diagnostic purposes should be frozen for further immunological cell analysis.
If patients undergoing elective surgery in the abdominal cavity are suspected of having a liver disease (e.g., altered liver parameters in the blood) and a wedge biopsy of the liver will be performed intraoperatively for diagnostics, tissue that is not required for diagnostic purposes should be prepared for further immunological cell analysis.
In addition, a part of the liver tissue obtained should be preserved for later genetic studies, e.g. in RNA-later.
In case of acute liver disease, further blood samples should be taken 48 and 96 h later and on weeks 1, 2, 4, 6, and 12, and after 6 and 12 months, respectively (or at the respective visits to the outpatient clinic).
For patients with chronic liver disease, blood should be re-collected during their regular visits at the outpatient clinic
In addition to patient history and medical information, the patients should also be regularly examined during the entire duration of the study and medical information, that are regularly collected during routine laboratory work ups (e.g. viral titers by quantitative PCR, liver enzymes and liver function) will be included.
To compare the immune responses, lymphocytes from patients without liver disease will be examined. will be investigated. Furthermore, healthy blood donors will be used as an additional control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver disease | – | –Patients with either acute or chronic liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic or acute liver disease undergoing surgery.
Key inclusion criteria (3 listed)
- Patients with chronic liver disease up to progressive cirrhosis (e.g. ethyltoxic, Viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC).
- Patients with elevated liver values undergoing elective abdominal surgery.
- As comparison groups patients with acute hepatitis (e.g. viral or autoimmune genesis) and patients without liver disease.
Key exclusion criteria (1 listed)
- Age under 18
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 |
|---|---|---|
| Also: No Interventionjust observational blood and liver sampling | Other | Liver disease |
Primary outcome
Liver fibrosis
Time frame: Day 0
Stage of liver fibrosis in histology (Ishak-score (1 - 6))
Liver Steatosis
Time frame: Day 0
Stage of liver steatosis in histology (NASH activity score (1 - 8))
1 secondary outcome
Survival
Time frame: After 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Undecided. Depending on data safety plan
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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. 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 Chronic Liver Disease, run by University of Regensburg at 1 site in Germany.
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 3 inclusion and 1 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 29 Jun 2021. 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 Germany. 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 Jens M. Werner, MD (+49941944 ext. 16808, jens.werner@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fibrosis (time frame: Day 0). The study lists 2 primary outcomes in all. 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 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.