Liver CirrhosisNCT03446521
AGRA Before and After Liver Transplantation
An observational study of Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
Trial summary
The immune system is impaired in liver cirrhotic patients, which is associated with a high risk for bacterial infections and worse outcome. A novel biomarker, acellular growth retardation ability (AGRA), can predict the development of severe infections in patients with liver cirrhosis and therefore identify patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 76 participants
- Where
- 1 siteAustria
- Study dates
- 6 Jul 2018to Dec 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients listed for liver transplantation at the University Hospital in Graz, Austria for any reason will be included in the study. The respective donors will serve as a control cohort.
Who may be able to join
- Patients between 18-80 years
- Listed for liver transplantation (for recipients)
- Liver recipient is included in the study (for donors)
- Informed consent
Who cannot join
- Antibiotic therapy with substances active against E. coli at the scheduled blood sampling
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Internal Medicine, Medical University of Geraz
Graz, 8036
About this study
Official title: Humoral Immune Status in Patients With Liver Cirrhosis Before and After Liver Transplantation
The immune system is impaired in liver cirrhotic patients, which is associated with a high risk for bacterial infections and worse outcome. A novel biomarker, acellular growth retardation ability (AGRA), can predict the development of severe infections in patients with liver cirrhosis and therefore identify patients at risk. It is still unclear, how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections. Therefore, AGRA will be measured before and after liver transplantation and predictive merit of AGRA for post-transplant infections will be tested.
Read the detailed description
Cirrhosis-associated immune dysfunction syndrome (CAIDS) is a well-recognized phenomenon. It affects all immune cells as well as the humoral immune system. Because of this deficiency patients with liver cirrhosis often suffer from severe infections that can be complicated by sepsis, acute renal or liver failure, and lead to prolonged hospitalization and ultimately to the death of the patient. The humoral immune system is a first-line defence mechanism and consists of cell-free molecules that are partly produced by the liver and target pathogens through opsonisation, growth inhibition and lysis. A cirrhotic liver cannot reach its full protein expression capacity and consequently, quantitative and qualitative changes of complement factors and immunoglobulins have been observed in liver disease patients before.
Liver transplantation remains the only curative option to treat liver cirrhosis and its extrahepatic manifestations; however due to limited organ supply this option is not applicable in all cases. Therefore, liver cirrhosis and its complications (eg. infections) need to be managed by health care professionals, who often lack appropriate tools for risk assessment. To meet this clinical need, a novel biomarker was recently established (Acellular Growth Retardation Ability, short AGRA) that uses the state of the humoral immune system to predict the future occurrence of severe infection in liver disease patients. However, it is still unclear how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections.
Therefore, patients scheduled for liver transplantation will be included in the trial. AGRA measurements before and after the transplant (1, 7, 90 days after the end of antibiotic treatment) will be performed. Additionally outcome data regarding severe infections are collected for one year before and after transplantation. The respective organ donors are included as a control group.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Patients undergoing liver transplantation, no intervention (study-specific) is planed | |
| Control Group | Respective organ donors of the included liver recipients, no intervention (study-specific) is planed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Acellular growth retardation ability (AGRA)
Functional biomarker for the state of the humoral immune system
Measured: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
Secondary outcomes (5)
Infections
Occurrence of severe infections
Measured: 1 year after transplantation
Infections
Occurrence of severe infections
Measured: 1 year before transplantation
Complications
Occurrence of transplantation-related complications
Measured: during hospital stay
C reactive protein
routine biomarker for infections
Measured: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
Liver function
State of the donated liver, including results of a possible liver biopsy prior to transplantation
Measured: before transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start6 Jul 2018
- Primary completion31 May 2023
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446521
- Sponsor's protocol ID
- AGRA-TX
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral Immune Status in Patients With Liver Cirrhosis Before and After Liver Transplantation
- ClinicalTrials.gov ID
- NCT03446521
- Acronym / sponsor ID
- AGRA-TX
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Feb 2018 (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 impaired in liver cirrhotic patients, which is associated with a high risk for bacterial infections and worse outcome. A novel biomarker, acellular growth retardation ability (AGRA), can predict the development of severe infections in patients with liver cirrhosis and therefore identify patients at risk. It is still unclear, how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections. Therefore, AGRA will be measured before and after liver transplantation and predictive merit of AGRA for post-transplant infections will be tested.
Detailed description
Cirrhosis-associated immune dysfunction syndrome (CAIDS) is a well-recognized phenomenon. It affects all immune cells as well as the humoral immune system. Because of this deficiency patients with liver cirrhosis often suffer from severe infections that can be complicated by sepsis, acute renal or liver failure, and lead to prolonged hospitalization and ultimately to the death of the patient. The humoral immune system is a first-line defence mechanism and consists of cell-free molecules that are partly produced by the liver and target pathogens through opsonisation, growth inhibition and lysis. A cirrhotic liver cannot reach its full protein expression capacity and consequently, quantitative and qualitative changes of complement factors and immunoglobulins have been observed in liver disease patients before.
Liver transplantation remains the only curative option to treat liver cirrhosis and its extrahepatic manifestations; however due to limited organ supply this option is not applicable in all cases. Therefore, liver cirrhosis and its complications (eg. infections) need to be managed by health care professionals, who often lack appropriate tools for risk assessment. To meet this clinical need, a novel biomarker was recently established (Acellular Growth Retardation Ability, short AGRA) that uses the state of the humoral immune system to predict the future occurrence of severe infection in liver disease patients. However, it is still unclear how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections.
Therefore, patients scheduled for liver transplantation will be included in the trial. AGRA measurements before and after the transplant (1, 7, 90 days after the end of antibiotic treatment) will be performed. Additionally outcome data regarding severe infections are collected for one year before and after transplantation. The respective organ donors are included as a control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | –Patients undergoing liver transplantation, no intervention (study-specific) is planed |
| Control Group | – | –Respective organ donors of the included liver recipients, no intervention (study-specific) is planed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for liver transplantation at the University Hospital in Graz, Austria for any reason will be included in the study. The respective donors will serve as a control cohort.
Key inclusion criteria (4 listed)
- Patients between 18-80 years
- Listed for liver transplantation (for recipients)
- Liver recipient is included in the study (for donors)
- Informed consent
Key exclusion criteria (1 listed)
- Antibiotic therapy with substances active against E. coli at the scheduled blood sampling
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
Change of Acellular growth retardation ability (AGRA)
Time frame: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
Functional biomarker for the state of the humoral immune system
5 secondary outcomes
Infections
Time frame: 1 year after transplantation
Infections
Time frame: 1 year before transplantation
Complications
Time frame: during hospital stay
C reactive protein
Time frame: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
Liver function
Time frame: before transplantation
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 13 Oct 2026.
- 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. 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?
An observational study of Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
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 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. 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 Austria. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Acellular growth retardation ability (AGRA) (time frame: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation). 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 13 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.