Haematopoietic Stem Cell TransplantationCIRCLENCT07915505
Specific Immune Reconstitution After Allogeneic Transplantation and Letermovir Prophylaxis
A study testing Letermovir and Comparator in people with Haematopoietic Stem Cell Transplantation and Antivirals, run by University Hospital, Limoges at 1 site in France.
Trial summary
Cytomegalovirus (CMV) is a major cause of morbidity in hematopoietic stem cell transplant recipients, with both direct effects, including CMV disease, and indirect effects, such as graft-versus-host disease (GVHD) and increased immunosuppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haematopoietic Stem Cell Transplantation, Antivirals, Cytomegalovirus Infections
- What is being tested?
- Letermovir and Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2022to 13 Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- CMV-seropositive patient included in the NAViRe cohort. Patient having signed a specific consent for the CIRCLE study.
Who cannot join
- Patient not included or not includible in the NAViRe cohort. Patient included in the NAViRe cohort but who refused the Circle protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specific Immune Reconstitution After Allogeneic Transplantation in Case of Preventive Anti-CMV Treatment With Letermovir.
Cytomegalovirus (CMV) is a major cause of morbidity in hematopoietic stem cell transplant recipients, with both direct effects, including CMV disease, and indirect effects, such as graft-versus-host disease (GVHD) and increased immunosuppression.
Virological monitoring and preemptive treatment with ganciclovir have reduced the incidence of CMV disease from approximately 30% to 2-6%, but have not eliminated the indirect morbidity associated with viral replication. Letermovir, a non-hematotoxic antiviral agent targeting the CMV terminase complex, has demonstrated efficacy in preventing CMV infection in this population.
The CIRCLE study aims to describe the evolution of global and CMV-specific immune reconstitution in CMV-seropositive hematopoietic stem cell transplant recipients receiving or not receiving letermovir prophylaxis, and to characterize the immune response over time.
Read the detailed description
Cytomegalovirus (CMV) remains an important cause of morbidity in hematopoietic stem cell transplant recipients. Its effects include direct complications, such as CMV disease, and indirect complications, including graft-versus-host disease (GVHD) and increased immunosuppression.
Virological monitoring and preemptive treatment with ganciclovir have reduced the incidence of CMV disease from approximately 30% to 2-6%, but have not eliminated the indirect morbidity associated with viral replication. Before the availability of preventive treatment, CMV-related complications represented a substantial burden and were associated with an additional cost estimated at 25-30% of the total cost of transplantation (Robin et al., 2017).
Letermovir, an antiviral agent targeting the CMV terminase complex, has demonstrated efficacy as prophylaxis against CMV infection in hematopoietic stem cell transplant recipients (Marty et al., 2017). However, immune reconstitution during prophylaxis, which may help inform the duration of preventive treatment, requires further investigation. Previous publications have suggested a delay in CMV-specific immune reconstitution, but a comprehensive assessment of the immune response remains necessary.
The CIRCLE study is a prospective, multicenter ancillary study of the French NaViRe cohort (NCT04690933). It aims to describe global and CMV-specific immune reconstitution over time in CMV-seropositive hematopoietic stem cell transplant recipients receiving or not receiving letermovir prophylaxis. The study uses research and commercial assays to characterize immune responses and explore their potential relevance to routine patient monitoring.
A total of 50 patients are planned for inclusion: 25 receiving letermovir prophylaxis and 25 not receiving letermovir prophylaxis. Immune responses will be evaluated using immunological and virological assessments during follow-up after transplantation, including assessments up to 12 months after transplantation.
- Being tested
- Letermovir, Comparator
- Keywords
- Cytomegalovirus, Immune reconstitution, Letermovir, Stem Cell Transplantation
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Letermovir administered as primary prophylaxis against cytomegalovirus infection in CMV-seropositive hematopoietic stem cell transplant recipients, according to standard clinical practice.
ComparatorOther
CMV-seropositive hematopoietic stem cell transplant recipients included in the Cryostem cohort who did not receive letermovir as primary prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving letermovir prophylaxis | Experimental | CMV-seropositive hematopoietic stem cell transplant recipients receiving letermovir as primary prophylaxis and included in the NAViRe cohort. The study will describe overall and CMV-specific immune reconstitution, including its evolution during follow-up, using immunological and virological assessments. Receives: Drug: Letermovir |
| Patients not receiving letermovir prophylaxis | Other | Observational Cohort. CMV-seropositive hematopoietic stem cell transplant recipients included in the Cryostem cohort who did not receive letermovir as primary prophylaxis. The study will describe overall and CMV-specific immune reconstitution, including assessments before transplantation and at day 100 after transplantation. Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load of torque teno virus (TTV) in whole blood
TTV viral load measured in whole blood and reported as copies/mL.
Measured: Before transplantation (Day -30 to Day -8), Day 20, Month 3, Month 6, and Month 12 after transplantation.
Qualitative and functional assessment of natural killer (NK) cells
Qualitative and functional analysis of NK cells and measurement of CD74 RNA expression.
Measured: Before transplantation (Day -30 to Day -8) and Day 100 after transplantation in patients not receiving letermovir prophylaxis.
CMV-specific cellular immune response
CMV-specific cellular immune response measured using QuantiFERON-CMV, ELISpot-CMV, and flow cytometry to quantify CMV-specific alpha-beta and gamma-delta T cells, including intracellular cytokine production and PD-1 receptor expression.
Measured: Before transplantation (Day -30 to Day -8), Day 20, Month 3, Month 6, and one month after the end of letermovir prophylaxis, as applicable. An additional assessment will be performed one month after CMV reactivation, if applicable.
CMV-specific IgG concentration in plasma
Quantification of CMV-specific IgG antibodies in plasma.
Measured: Before transplantation (Day -30 to Day -8), Day 20, Month 3, Month 6, and one month after the end of letermovir prophylaxis, as applicable.
Time to development of a significant CMV-specific cellular immune response
Time from transplantation to the first significant CMV-specific cellular immune response, defined by a positive QuantiFERON-CMV or ELISpot-CMV result according to the manufacturer's cut-offs, or detection of a CMV-specific T-cell response by flow cytometry following stimulation with CMV antigens.
Measured: From before transplantation (Day -30 to Day -8) through Month 12 after transplantation.
Number of participants with CMV infection
Number of participants with CMV infection, defined by a positive diagnostic test for CMV detection without clinical symptoms.
Measured: From before transplantation (Day -30 to Day -8) through Month 24 after transplantation.
Number of participants with CMV disease
Number of participants with CMV disease, defined as CMV infection associated with clinical symptoms and organ involvement.
Measured: From before transplantation (Day -30 to Day -8) through Month 24 after transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start6 Sep 2022
- Primary completion13 Apr 2026
- Study completion13 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Haematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Describe immune reconstitution global and anti-Cytomegalovirus in CMV-seropositive hematopoietic stem cell recipients as a factor of letermovir prophylaxis administration and duration
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Pascal TURLURE, Principal investigator, University Hospital, LimogesSophie Pr. ALAIN, Study director, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915505
- Sponsor's protocol ID
- 87RI19_0024_CIRCLE
- Acronym
- CIRCLE
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P; Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.
PubMed 30137245Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
PubMed 29596116Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28.
PubMed 27682069Marty FM, Ljungman P, Chemaly RF, Maertens J, Dadwal SS, Duarte RF, Haider S, Ullmann AJ, Katayama Y, Brown J, Mullane KM, Boeckh M, Blumberg EA, Einsele H, Snydman DR, Kanda Y, DiNubile MJ, Teal VL, Wan H, Murata Y, Kartsonis NA, Leavitt RY, Badshah C. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017 Dec 21;377(25):2433-2444. doi: 10.1056/NEJMoa1706640. Epub 2017 Dec 6.
PubMed 29211658Robin C, Hemery F, Dindorf C, Thillard J, Cabanne L, Redjoul R, Beckerich F, Rodriguez C, Pautas C, Toma A, Maury S, Durand-Zaleski I, Cordonnier C. Economic burden of preemptive treatment of CMV infection after allogeneic stem cell transplantation: a retrospective study of 208 consecutive patients. BMC Infect Dis. 2017 Dec 5;17(1):747. doi: 10.1186/s12879-017-2854-2.
PubMed 29207952
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Immune Reconstitution After Allogeneic Transplantation in Case of Preventive Anti-CMV Treatment With Letermovir.
- ClinicalTrials.gov ID
- NCT07915505
- Acronym / sponsor ID
- CIRCLE / 87RI19_0024_CIRCLE
- Keywords
- Cytomegalovirus, Immune reconstitution, Letermovir, Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Oct 2026 (actual)
- First posted
- 4 Nov 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.
Cytomegalovirus (CMV) is a major cause of morbidity in hematopoietic stem cell transplant recipients, with both direct effects, including CMV disease, and indirect effects, such as graft-versus-host disease (GVHD) and increased immunosuppression.
Virological monitoring and preemptive treatment with ganciclovir have reduced the incidence of CMV disease from approximately 30% to 2-6%, but have not eliminated the indirect morbidity associated with viral replication. Letermovir, a non-hematotoxic antiviral agent targeting the CMV terminase complex, has demonstrated efficacy in preventing CMV infection in this population.
The CIRCLE study aims to describe the evolution of global and CMV-specific immune reconstitution in CMV-seropositive hematopoietic stem cell transplant recipients receiving or not receiving letermovir prophylaxis, and to characterize the immune response over time.
Detailed description
Cytomegalovirus (CMV) remains an important cause of morbidity in hematopoietic stem cell transplant recipients. Its effects include direct complications, such as CMV disease, and indirect complications, including graft-versus-host disease (GVHD) and increased immunosuppression.
Virological monitoring and preemptive treatment with ganciclovir have reduced the incidence of CMV disease from approximately 30% to 2-6%, but have not eliminated the indirect morbidity associated with viral replication. Before the availability of preventive treatment, CMV-related complications represented a substantial burden and were associated with an additional cost estimated at 25-30% of the total cost of transplantation (Robin et al., 2017).
Letermovir, an antiviral agent targeting the CMV terminase complex, has demonstrated efficacy as prophylaxis against CMV infection in hematopoietic stem cell transplant recipients (Marty et al., 2017). However, immune reconstitution during prophylaxis, which may help inform the duration of preventive treatment, requires further investigation. Previous publications have suggested a delay in CMV-specific immune reconstitution, but a comprehensive assessment of the immune response remains necessary.
The CIRCLE study is a prospective, multicenter ancillary study of the French NaViRe cohort (NCT04690933). It aims to describe global and CMV-specific immune reconstitution over time in CMV-seropositive hematopoietic stem cell transplant recipients receiving or not receiving letermovir prophylaxis. The study uses research and commercial assays to characterize immune responses and explore their potential relevance to routine patient monitoring.
A total of 50 patients are planned for inclusion: 25 receiving letermovir prophylaxis and 25 not receiving letermovir prophylaxis. Immune responses will be evaluated using immunological and virological assessments during follow-up after transplantation, including assessments up to 12 months after transplantation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Describe immune reconstitution global and anti-Cytomegalovirus in CMV-seropositive hematopoietic stem cell recipients as a factor of letermovir prophylaxis administration and duration
| Arm | Type | Receives |
|---|---|---|
| Patients receiving letermovir prophylaxis | Experimental | Drug: LetermovirCMV-seropositive hematopoietic stem cell transplant recipients receiving letermovir as primary prophylaxis and included in the NAViRe cohort. The study will describe overall and CMV-specific immune reconstitution, including its evolution during follow-up, using immunological and virological assessments. |
| Patients not receiving letermovir prophylaxis | Other | Other: ComparatorObservational Cohort. CMV-seropositive hematopoietic stem cell transplant recipients included in the Cryostem cohort who did not receive letermovir as primary prophylaxis. The study will describe overall and CMV-specific immune reconstitution, including assessments before transplantation and at day 100 after transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CMV-seropositive patient included in the NAViRe cohort. Patient having signed a specific consent for the CIRCLE study.
Key exclusion criteria (1 listed)
- Patient not included or not includible in the NAViRe cohort. Patient included in the NAViRe cohort but who refused the Circle protocol.
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 |
|---|---|---|
| LetermovirLetermovir administered as primary prophylaxis against cytomegalovirus infection in CMV-seropositive hematopoietic stem cell transplant recipients, according to standard clinical practice. | Drug | Patients receiving letermovir prophylaxis |
| ComparatorCMV-seropositive hematopoietic stem cell transplant recipients included in the Cryostem cohort who did not receive letermovir as primary prophylaxis. | Other | Patients not receiving letermovir prophylaxis |
Primary outcome
Viral load of torque teno virus (TTV) in whole blood
Time frame: Before transplantation (Day -30 to Day -8), Day 20, Month 3, Month 6, and Month 12 after transplantation.
TTV viral load measured in whole blood and reported as copies/mL.
Qualitative and functional assessment of natural killer (NK) cells
Time frame: Before transplantation (Day -30 to Day -8) and Day 100 after transplantation in patients not receiving letermovir prophylaxis.
Qualitative and functional analysis of NK cells and measurement of CD74 RNA expression.
CMV-specific cellular immune response
Time frame: Before transplantation (Day -30 to Day -8), Day 20, Month 3, Month 6, and one month after the end of letermovir prophylaxis, as applicable. An additional assessment will be performed one month after CMV reactivation, if applicable.
CMV-specific cellular immune response measured using QuantiFERON-CMV, ELISpot-CMV, and flow cytometry to quantify CMV-specific alpha-beta and gamma-delta T cells, including intracellular cytokine production and PD-1 receptor expression.
CMV-specific IgG concentration in plasma
Time frame: Before transplantation (Day -30 to Day -8), Day 20, Month 3, Month 6, and one month after the end of letermovir prophylaxis, as applicable.
Quantification of CMV-specific IgG antibodies in plasma.
Time to development of a significant CMV-specific cellular immune response
Time frame: From before transplantation (Day -30 to Day -8) through Month 12 after transplantation.
Time from transplantation to the first significant CMV-specific cellular immune response, defined by a positive QuantiFERON-CMV or ELISpot-CMV result according to the manufacturer's cut-offs, or detection of a CMV-specific T-cell response by flow cytometry following stimulation with CMV antigens.
Number of participants with CMV infection
Time frame: From before transplantation (Day -30 to Day -8) through Month 24 after transplantation.
Number of participants with CMV infection, defined by a positive diagnostic test for CMV detection without clinical symptoms.
Number of participants with CMV disease
Time frame: From before transplantation (Day -30 to Day -8) through Month 24 after transplantation.
Number of participants with CMV disease, defined as CMV infection associated with clinical symptoms and organ involvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 30137245Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P; Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.
- Background: PubMed 29596116Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
- Background: PubMed 27682069Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28.
- Background: PubMed 29211658Marty FM, Ljungman P, Chemaly RF, Maertens J, Dadwal SS, Duarte RF, Haider S, Ullmann AJ, Katayama Y, Brown J, Mullane KM, Boeckh M, Blumberg EA, Einsele H, Snydman DR, Kanda Y, DiNubile MJ, Teal VL, Wan H, Murata Y, Kartsonis NA, Leavitt RY, Badshah C. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017 Dec 21;377(25):2433-2444. doi: 10.1056/NEJMoa1706640. Epub 2017 Dec 6.
- Background: PubMed 29207952Robin C, Hemery F, Dindorf C, Thillard J, Cabanne L, Redjoul R, Beckerich F, Rodriguez C, Pautas C, Toma A, Maury S, Durand-Zaleski I, Cordonnier C. Economic burden of preemptive treatment of CMV infection after allogeneic stem cell transplantation: a retrospective study of 208 consecutive patients. BMC Infect Dis. 2017 Dec 5;17(1):747. doi: 10.1186/s12879-017-2854-2.
- Individual participant dataSharing planned: Undecided
Related trials for Haematopoietic Stem Cell Transplantation
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
RecruitingPhase 2
Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
Hematologic Diseases
RecruitingPhase 1/2
PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCT
GVHD - Graft-Versus-Host Disease
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.
Dr. Pascal TURLURE principal investigator
University Hospital, Limoges
Sophie Pr. ALAIN study director
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letermovir and Comparator in people with Haematopoietic Stem Cell Transplantation and Antivirals, run by University Hospital, Limoges at 1 site in France.
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: finished, as of the sponsor's last update on 4 Nov 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Viral load of torque teno virus (TTV) in whole blood (time frame: Before transplantation (Day -30 to Day -8), Day 20, Month 3, Month 6, and Month 12 after transplantation.). The study lists 7 primary outcomes in all. 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 NCT07915505, which also lists 5 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 4 Nov 2026.