Liver Transplantation (LT)NCT07875595
Immune Biomarkers for Predicting Complications After Liver Transplantation
An observational study of Liver Transplantation (LT) and Immuno-suppression, run by Hospital Italiano de Buenos Aires at 3 sites in Argentina.
Trial summary
This multicenter prospective observational study will evaluate immune biomarkers in adults undergoing liver transplantation. The study aims to describe how immune markers change before and after transplantation and to assess whether these changes are associated with complications such as infections, acute cellular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation (LT), Immuno-suppression, Biomarkers / Blood
- What is being tested?
- Immune Biomarker Assessment
- How many people
- 60 participants
- Where
- 3 sitesArgentina
- Study dates
- 2 Mar 2026to Mar 2028
- 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: Adult liver transplant recipients treated at Hospital Italiano de Buenos Aires, Hospital Universitario Austral, or Hospital Alemán de Buenos Aires.
Who may be able to join
- Age 18 years or older. Adult patients admitted to the intensive care unit after liver transplantation.
Who cannot join
- Refusal to participate in the study. Liver transplantation performed for acute liver failure (fulminant hepatitis).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina3 sites, 3 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., 1199
alicia Gira, MD, +54 230 448-2000, aliciaroxanagira@gmail.com
Daniel Ivulich, MD, +54 11 4827-7000, diivulich@gmail.com
- Recruiting
Hospital Aleman
Buenos Aires, Buenos Aires F.D., C1118AAT
Daniel Ivulich, MD, +54 11 4827-7000, diivulich@gmail.com
Daniel Ivulich, MD
- Recruiting
Hospital Universitario Austral
Pilar, Buenos Aires, B1629
Alicia Gira, MD, +54 230 448-2000, aliciaroxanagira@gmail.com
Alicia Gira, MD
About this study
Official title: Estudio Multicéntrico de Biomarcadores Inmunológicos Para la Predicción de Complicaciones y Ajuste de la Inmunosupresión en Trasplante Hepático.
This multicenter prospective observational study will evaluate immune biomarkers in adults undergoing liver transplantation. The study aims to describe how immune markers change before and after transplantation and to assess whether these changes are associated with complications such as infections, acute cellular rejection, and viral reactivation during the first year after transplantation.
Blood samples will be collected before transplantation, on days 0, 3, and 7 after transplantation, and at months 1, 3, 6, and 12. Biomarkers evaluated will include cytokines, interferons, immunoglobulins, lymphocyte populations, monocyte HLA-DR, neutrophil CD64, functional immune assays, checkpoint molecules, and Torque Teno Virus. Clinical outcomes will be recorded prospectively. Biomarker results will be used for research purposes only and will not modify immunosuppressive treatment or other clinical decisions.
Read the detailed description
This is a multicenter, observational, analytical, prospective cohort study conducted at three liver transplant centers in Buenos Aires, Argentina: Hospital Italiano de Buenos Aires, Hospital Universitario Austral, and Hospital Alemán de Buenos Aires.
The study will include 60 adult liver transplant recipients. Serial blood samples will be obtained before transplantation and on days 0, 3, and 7, as well as at months 1, 3, 6, and 12 after transplantation. Early immune profiling will include pro-inflammatory and anti-inflammatory cytokines and interferons. Additional immune markers include immunoglobulins, lymphocyte populations, monocyte HLA-DR expression, neutrophil CD64, ex vivo lipopolysaccharide-stimulated TNF-alpha production, checkpoint molecules, and Torque Teno Virus.
Participants will be followed prospectively for clinical outcomes including infections, acute cellular rejection, hospitalizations, and viral reactivations. The study will evaluate longitudinal biomarker trajectories and their association with these clinical outcomes, including their potential diagnostic and predictive performance.
All biomarker measurements are performed for research purposes only. Results will not be used to guide or modify immunosuppressive therapy, which will remain under the responsibility of the treating clinical team.
- Being tested
- Immune Biomarker Assessment
- Keywords
- Biomarkers, immunosuppression, Acute Cellular Rejection, Infection, Viral Reactivation, Liver Transplantation
- Medical subject headings
- Rejection, Psychology, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Biomarker AssessmentOther
Serial measurement of immune biomarkers in blood samples collected before liver transplantation and on days 0, 3, and 7 and months 1, 3, 6, and 12 after transplantation. Biomarkers include cytokines, interferons, immunoglobulins, lymphocyte populations, monocyte HLA-DR, neutrophil CD64, functional immune assays, checkpoint molecules, and Torque Teno Virus. All measurements are performed for research purposes only and do not modify clinical management or immunosuppressive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Immune-Mediated Liver Disease | Liver transplant recipients with immune-mediated liver disease. Receives: Other: Immune Biomarker Assessment | |
| Non-Immune-Mediated Liver Disease | Liver transplant recipients with non-immune-mediated liver disease. Receives: Other: Immune Biomarker Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Change in Early Serum Cytokine and Interferon Concentrations
Change over time in serum concentrations of IL-1β, IL-6, IL-8, IL-12, IL-17A, IL-18, TNF-α, MCP-1, IFN-α2, IFN-γ, IL-10, and TGF-β, comparing liver transplant recipients with immune-mediated versus non-immune-mediated liver disease. Concentrations will be measured in pg/mL. Analyses will be adjusted for the immunosuppressive regimen at each time point, including drug type, dose, and tacrolimus trough concentration.
Measured: Pre-transplant and days 0, 3, and 7 after liver transplantation
Secondary outcomes (7)
Longitudinal Change in Immunoglobulin Levels and Leukocyte Profile
Change over time in serum immunoglobulin concentrations and leukocyte profile during the first year after liver transplantation, comparing recipients with immune-mediated versus non-immune-mediated liver disease. Analyses will be adjusted for the immunosuppressive regimen at each time point, including drug type, dose, and tacrolimus trough concentration.
Measured: Months 1, 3, 6, and 12 after liver transplantation
Occurrence of Post-Transplant Infections
Occurrence of infections after liver transplantation and their association with longitudinal immune biomarker measurements to evaluate predictive performance.
Measured: During index hospitalization, 0-3 months, and 3-12 months after liver transplantation
Diagnostic Performance of HLA-DR and CD64 for Bacterial Infection
Diagnostic performance of monocyte HLA-DR and neutrophil CD64 for distinguishing bacterial from non-bacterial infections in liver transplant recipients with suspected infection. Performance will be assessed using ROC curves, AUC, predictive values, and likelihood ratios.
Measured: During the first 12 months after liver transplantation
Occurrence of Acute Cellular Rejection
Occurrence of acute cellular rejection and its association with longitudinal immune biomarker measurements during the first year after liver transplantation.
Measured: Up to 12 months after liver transplantation
Occurrence of CMV and Other Herpesvirus Reactivation
Occurrence of CMV or other herpesvirus reactivation and its association with cellular and humoral biomarkers, including NK cells, regulatory T cells, immunoglobulins, and leukocyte profile.
Measured: Up to 12 months after liver transplantation
Association of Torque Teno Virus Levels With Infection, Rejection, and Tacrolimus Exposure
Association of Torque Teno Virus (TTV) levels with the occurrence of infection and acute rejection, and longitudinal association between TTV levels and tacrolimus concentrations as a marker of immunosuppression.
Measured: Months 1, 3, 6, and 12 after liver transplantation
Association Between Immunosuppression Intensity and Longitudinal Immune Biomarker Trajectories
Association between immunosuppression intensity, defined by immunosuppressive regimen, drug doses, and tacrolimus trough concentrations, and longitudinal trajectories of immune biomarkers. The analysis will explore whether this association differs according to immune-mediated versus non-immune-mediated liver disease.
Measured: From transplantation through 12 months after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start2 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Liver Transplantation (LT)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Austral University, Argentina, Hospital Aleman
- Responsible party
- Principal investigator, JORGE CARLOS MARTINEZ MORALES, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875595
- Sponsor's protocol ID
- HIBAIMMUNOTH
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because study data are coded, stored with restricted access, and managed in accordance with institutional confidentiality and data protection requirements.
Publications
Heldman MR, Dunn B, Clemens E, Henderson M, Fisher CE, Rakita RM, Kling CE, Limaye AP. A practical guide to real-world implementation of pre-emptive therapy for Cytomegalovirus disease prevention in high-risk seronegative liver transplant recipients with seropositive donors. Transpl Infect Dis. 2024 Jun;26(3):e14229. doi: 10.1111/tid.14229. Epub 2024 Jan 12.
PubMed 38214192Reiss-Gindi N, Hoffman T, Ruderman T, Atamna A, Margalit I, Yahav D. Prophylactic vs preemptive strategy for the prevention of CMV disease in solid organ transplant recipients: systematic review and meta-analysis of randomized controlled trials. Infection. 2025 Jun;53(3):1091-1099. doi: 10.1007/s15010-024-02441-4. Epub 2024 Nov 22.
PubMed 39576569Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30.
PubMed 37899366Lizaola-Mayo BC, Rodriguez EA. Cytomegalovirus infection after liver transplantation. World J Transplant. 2020 Jul 29;10(7):183-190. doi: 10.5500/wjt.v10.i7.183.
PubMed 32844094Fontela PS, O'Donnell S, Papenburg J. Can biomarkers improve the rational use of antibiotics? Curr Opin Infect Dis. 2018 Aug;31(4):347-352. doi: 10.1097/QCO.0000000000000467.
PubMed 29794541Patterson TF, Thompson GR 3rd, Denning DW, Fishman JA, Hadley S, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Nguyen MH, Segal BH, Steinbach WJ, Stevens DA, Walsh TJ, Wingard JR, Young JA, Bennett JE. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016 Aug 15;63(4):e1-e60. doi: 10.1093/cid/ciw326. Epub 2016 Jun 29.
PubMed 27365388Salmanton-Garcia J, Giacinta A, Giannella M, Vena A, Munoz P, Cornely OA, Valerio M. Current trends on antifungal prophylaxis in solid organ transplantation: a study from ESCMID-EFISG, ESCMID-ESGICH, SITA, and SEIMC-GESITRA-IC. Infection. 2025 Dec;53(6):2411-2420. doi: 10.1007/s15010-025-02575-z. Epub 2025 Jul 4.
PubMed 40614031Denzel C, Riese J, Hohenberger W, Born G, Kockerling F, Tschaikowsky K, Reith HB, Reck T, Haupt W. Monitoring of immunotherapy by measuring monocyte HLA-DR expression and stimulated TNFalpha production during sepsis after liver transplantation. Intensive Care Med. 1998 Dec;24(12):1343-4. doi: 10.1007/s001340050775. No abstract available.
PubMed 9885893Peng B, Yang M, Zhuang Q, Li J, Zhang P, Liu H, Cheng K, Ming Y. Standardization of neutrophil CD64 and monocyte HLA-DR measurement and its application in immune monitoring in kidney transplantation. Front Immunol. 2022 Nov 23;13:1063957. doi: 10.3389/fimmu.2022.1063957. eCollection 2022.
PubMed 36505404Haveman JW, van den Berg AP, van den Berk JM, Mesander G, Slooff MJ, de Leij LH, The TH. Low HLA-DR expression on peripheral blood monocytes predicts bacterial sepsis after liver transplantation: relation with prednisolone intake. Transpl Infect Dis. 1999 Sep;1(3):146-52. doi: 10.1034/j.1399-3062.1999.010302.x.
PubMed 11428984Regele F, Haupenthal F, Doberer K, Gorzer I, Kapps S, Strassl R, Bond G. The kinetics of Torque Teno virus plasma load following calcineurin inhibitor dose change in kidney transplant recipients. J Med Virol. 2024 Mar;96(3):e29554. doi: 10.1002/jmv.29554.
PubMed 38511586Engel B, Gorzer I, Campos-Murguia A, Hartleben B, Puchhammer-Stockl E, Jaeckel E, Taubert R. Association of torque teno virus viremia with liver fibrosis in the first year after liver transplantation. Front Immunol. 2023 Jul 18;14:1215868. doi: 10.3389/fimmu.2023.1215868. eCollection 2023.
PubMed 37533865Ruiz P, Martinez-Picola M, Santana M, Munoz J, Perez-Del-Pulgar S, Koutsoudakis G, Sastre L, Colmenero J, Crespo G, Navasa M. Torque Teno Virus Is Associated With the State of Immune Suppression Early After Liver Transplantation. Liver Transpl. 2019 Feb;25(2):302-310. doi: 10.1002/lt.25374.
PubMed 30375165Mian M, Natori Y, Ferreira V, Selzner N, Husain S, Singer L, Kim SJ, Humar A, Kumar D. Evaluation of a Novel Global Immunity Assay to Predict Infection in Organ Transplant Recipients. Clin Infect Dis. 2018 Apr 17;66(9):1392-1397. doi: 10.1093/cid/cix1008.
PubMed 29281051Sood S, Haifer C, Yu L, Pavlovic J, Churilov L, Gow PJ, Jones RM, Angus PW, Visvanathan K, Testro AG. A novel immune function biomarker identifies patients at risk of clinical events early following liver transplantation. Liver Transpl. 2017 Apr;23(4):487-497. doi: 10.1002/lt.24730.
PubMed 28133934
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Multicéntrico de Biomarcadores Inmunológicos Para la Predicción de Complicaciones y Ajuste de la Inmunosupresión en Trasplante Hepático.
- ClinicalTrials.gov ID
- NCT07875595
- Acronym / sponsor ID
- HIBAIMMUNOTH
- Keywords
- Biomarkers, immunosuppression, Acute Cellular Rejection, Infection, Viral Reactivation, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Austral University, Argentina, Hospital Aleman
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Oct 2026 (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.
This multicenter prospective observational study will evaluate immune biomarkers in adults undergoing liver transplantation. The study aims to describe how immune markers change before and after transplantation and to assess whether these changes are associated with complications such as infections, acute cellular rejection, and viral reactivation during the first year after transplantation.
Blood samples will be collected before transplantation, on days 0, 3, and 7 after transplantation, and at months 1, 3, 6, and 12. Biomarkers evaluated will include cytokines, interferons, immunoglobulins, lymphocyte populations, monocyte HLA-DR, neutrophil CD64, functional immune assays, checkpoint molecules, and Torque Teno Virus. Clinical outcomes will be recorded prospectively. Biomarker results will be used for research purposes only and will not modify immunosuppressive treatment or other clinical decisions.
Detailed description
This is a multicenter, observational, analytical, prospective cohort study conducted at three liver transplant centers in Buenos Aires, Argentina: Hospital Italiano de Buenos Aires, Hospital Universitario Austral, and Hospital Alemán de Buenos Aires.
The study will include 60 adult liver transplant recipients. Serial blood samples will be obtained before transplantation and on days 0, 3, and 7, as well as at months 1, 3, 6, and 12 after transplantation. Early immune profiling will include pro-inflammatory and anti-inflammatory cytokines and interferons. Additional immune markers include immunoglobulins, lymphocyte populations, monocyte HLA-DR expression, neutrophil CD64, ex vivo lipopolysaccharide-stimulated TNF-alpha production, checkpoint molecules, and Torque Teno Virus.
Participants will be followed prospectively for clinical outcomes including infections, acute cellular rejection, hospitalizations, and viral reactivations. The study will evaluate longitudinal biomarker trajectories and their association with these clinical outcomes, including their potential diagnostic and predictive performance.
All biomarker measurements are performed for research purposes only. Results will not be used to guide or modify immunosuppressive therapy, which will remain under the responsibility of the treating clinical team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune-Mediated Liver Disease | – | Other: Immune Biomarker AssessmentLiver transplant recipients with immune-mediated liver disease. |
| Non-Immune-Mediated Liver Disease | – | Other: Immune Biomarker AssessmentLiver transplant recipients with non-immune-mediated liver disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult liver transplant recipients treated at Hospital Italiano de Buenos Aires, Hospital Universitario Austral, or Hospital Alemán de Buenos Aires.
Key inclusion criteria (1 listed)
- Age 18 years or older. Adult patients admitted to the intensive care unit after liver transplantation.
Key exclusion criteria (1 listed)
- Refusal to participate in the study. Liver transplantation performed for acute liver failure (fulminant hepatitis).
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 |
|---|---|---|
| Immune Biomarker AssessmentSerial measurement of immune biomarkers in blood samples collected before liver transplantation and on days 0, 3, and 7 and months 1, 3, 6, and 12 after transplantation. Biomarkers include cytokines, interferons, immunoglobulins, lymphocyte populations, monocyte HLA-DR, neutrophil CD64, functional immune assays, checkpoint molecules, and Torque Teno Virus. All measurements are performed for research purposes only and do not modify clinical management or immunosuppressive treatment. | Other | Immune-Mediated Liver Disease, Non-Immune-Mediated Liver Disease |
Primary outcome
Longitudinal Change in Early Serum Cytokine and Interferon Concentrations
Time frame: Pre-transplant and days 0, 3, and 7 after liver transplantation
Change over time in serum concentrations of IL-1β, IL-6, IL-8, IL-12, IL-17A, IL-18, TNF-α, MCP-1, IFN-α2, IFN-γ, IL-10, and TGF-β, comparing liver transplant recipients with immune-mediated versus non-immune-mediated liver disease. Concentrations will be measured in pg/mL. Analyses will be adjusted for the immunosuppressive regimen at each time point, including drug type, dose, and tacrolimus trough concentration.
7 secondary outcomes
Longitudinal Change in Immunoglobulin Levels and Leukocyte Profile
Time frame: Months 1, 3, 6, and 12 after liver transplantation
Occurrence of Post-Transplant Infections
Time frame: During index hospitalization, 0-3 months, and 3-12 months after liver transplantation
Diagnostic Performance of HLA-DR and CD64 for Bacterial Infection
Time frame: During the first 12 months after liver transplantation
Occurrence of Acute Cellular Rejection
Time frame: Up to 12 months after liver transplantation
Occurrence of CMV and Other Herpesvirus Reactivation
Time frame: Up to 12 months after liver transplantation
Association of Torque Teno Virus Levels With Infection, Rejection, and Tacrolimus Exposure
Time frame: Months 1, 3, 6, and 12 after liver transplantation
Association Between Immunosuppression Intensity and Longitudinal Immune Biomarker Trajectories
Time frame: From transplantation through 12 months after liver 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 15 Oct 2026.
- Background: PubMed 38214192Heldman MR, Dunn B, Clemens E, Henderson M, Fisher CE, Rakita RM, Kling CE, Limaye AP. A practical guide to real-world implementation of pre-emptive therapy for Cytomegalovirus disease prevention in high-risk seronegative liver transplant recipients with seropositive donors. Transpl Infect Dis. 2024 Jun;26(3):e14229. doi: 10.1111/tid.14229. Epub 2024 Jan 12.
- Background: PubMed 39576569Reiss-Gindi N, Hoffman T, Ruderman T, Atamna A, Margalit I, Yahav D. Prophylactic vs preemptive strategy for the prevention of CMV disease in solid organ transplant recipients: systematic review and meta-analysis of randomized controlled trials. Infection. 2025 Jun;53(3):1091-1099. doi: 10.1007/s15010-024-02441-4. Epub 2024 Nov 22.
- Background: PubMed 37899366Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30.
- Background: PubMed 32844094Lizaola-Mayo BC, Rodriguez EA. Cytomegalovirus infection after liver transplantation. World J Transplant. 2020 Jul 29;10(7):183-190. doi: 10.5500/wjt.v10.i7.183.
- Background: PubMed 29794541Fontela PS, O'Donnell S, Papenburg J. Can biomarkers improve the rational use of antibiotics? Curr Opin Infect Dis. 2018 Aug;31(4):347-352. doi: 10.1097/QCO.0000000000000467.
- Background: PubMed 27365388Patterson TF, Thompson GR 3rd, Denning DW, Fishman JA, Hadley S, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Nguyen MH, Segal BH, Steinbach WJ, Stevens DA, Walsh TJ, Wingard JR, Young JA, Bennett JE. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016 Aug 15;63(4):e1-e60. doi: 10.1093/cid/ciw326. Epub 2016 Jun 29.
- Background: PubMed 40614031Salmanton-Garcia J, Giacinta A, Giannella M, Vena A, Munoz P, Cornely OA, Valerio M. Current trends on antifungal prophylaxis in solid organ transplantation: a study from ESCMID-EFISG, ESCMID-ESGICH, SITA, and SEIMC-GESITRA-IC. Infection. 2025 Dec;53(6):2411-2420. doi: 10.1007/s15010-025-02575-z. Epub 2025 Jul 4.
- Background: PubMed 9885893Denzel C, Riese J, Hohenberger W, Born G, Kockerling F, Tschaikowsky K, Reith HB, Reck T, Haupt W. Monitoring of immunotherapy by measuring monocyte HLA-DR expression and stimulated TNFalpha production during sepsis after liver transplantation. Intensive Care Med. 1998 Dec;24(12):1343-4. doi: 10.1007/s001340050775. No abstract available.
- Background: PubMed 36505404Peng B, Yang M, Zhuang Q, Li J, Zhang P, Liu H, Cheng K, Ming Y. Standardization of neutrophil CD64 and monocyte HLA-DR measurement and its application in immune monitoring in kidney transplantation. Front Immunol. 2022 Nov 23;13:1063957. doi: 10.3389/fimmu.2022.1063957. eCollection 2022.
- Background: PubMed 11428984Haveman JW, van den Berg AP, van den Berk JM, Mesander G, Slooff MJ, de Leij LH, The TH. Low HLA-DR expression on peripheral blood monocytes predicts bacterial sepsis after liver transplantation: relation with prednisolone intake. Transpl Infect Dis. 1999 Sep;1(3):146-52. doi: 10.1034/j.1399-3062.1999.010302.x.
- Background: PubMed 38511586Regele F, Haupenthal F, Doberer K, Gorzer I, Kapps S, Strassl R, Bond G. The kinetics of Torque Teno virus plasma load following calcineurin inhibitor dose change in kidney transplant recipients. J Med Virol. 2024 Mar;96(3):e29554. doi: 10.1002/jmv.29554.
- Background: PubMed 37533865Engel B, Gorzer I, Campos-Murguia A, Hartleben B, Puchhammer-Stockl E, Jaeckel E, Taubert R. Association of torque teno virus viremia with liver fibrosis in the first year after liver transplantation. Front Immunol. 2023 Jul 18;14:1215868. doi: 10.3389/fimmu.2023.1215868. eCollection 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because study data are coded, stored with restricted access, and managed in accordance with institutional confidentiality and data protection requirements.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation (LT) and Immuno-suppression, run by Hospital Italiano de Buenos Aires at 3 sites in Argentina.
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 1 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: looking for participants now, as of the sponsor's last update on 15 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 3 sites in Argentina. 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 Jorge Martinez, MD (+541149590200 ext. 8635, jorgec.martinez@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Change in Early Serum Cytokine and Interferon Concentrations (time frame: Pre-transplant and days 0, 3, and 7 after liver transplantation). 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 NCT07875595, which also lists 26 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 15 Oct 2026.