Cytomegalovirus InfectionsHORUSNCT05701228
Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation
An observational study of Cytomegalovirus Infections and Solid Organ Transplantation, run by University Hospital, Bordeaux at 7 sites in France.
Trial summary
CMV disease remains the most frequent infectious complication post-transplant and it is associated to high morbidity and even mortality. Global efforts from both transplant physicians and researchers in the field is needed to better characterize the host-virus interactions in the transplant setting, with the aim of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections, Solid Organ Transplantation
- How many people
- 552 participants
- Where
- 7 sitesFrance
- Study dates
- 26 Jun 2023to Dec 2026
- 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: Cohort 1 will include 450 patients at the time of transplantation: Kidney: 6 groups : 50 R+ATG no mTORi, 30 R+ATG mTORi, 50 R+ no ATG no mTORi, 30 R+ no ATG mTORi, 50 D+R- no mTORi, 30 D+R- mTORi Lung: 3 groups of 20 patients R+ ATG,R+ no ATG, D+R- Heart: 3 groups of 30 patients R+ ATG, R+ no ATG, D+R- Liver: 3 groups of 20 patients R+ ATG, R+ no ATG, D+R- Cohort 2 will include 150 patients at the time of the infection: Approximatively 75 patients are expected to roll-over from the cohort of solid-organ transplant recipients included at day 0 of transplantation (cohort 1). Additional 75 patients developing a CMV infection will be also included.
Who may be able to join
None listed.
Who cannot join
- D-R- recipients,
- participant unable or unwilling to comply with study procedures,
- subjects who are legally detained in an official institution.
- A cohort 2 of solid-organ transplant recipients at day 0 of infection:
- Consecutive patients meeting the following inclusion criteria will be included:
- Men and women,
Show all 14Show fewer
- Age >= 18 years receiving a (living or deceased donor) kidney, lung, liver, and heart allograft
- written informed consent obtained from subject,
- ability to understand and give their written consent,
- affiliated to health insurance,
- post-transplant CMV infection episode.
- D-R- recipients,
- participant unable or unwilling to comply with study procedures,
- subjects who are legally detained in an official institution.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hopitel Pellegrin
Bordeaux, 33076
Hôpital Edouard Hériot
Lyon, 69003
Hôpital LA PITIE SALPETRIERE
Paris, 75013
Hôpital Necker
Paris, 75015
Hôpital Foch
Suresnes, 92150
Hôpital Rangueil
Toulouse, 31059
Hôpital Paul Brousse
Villejuif, 94804
About this study
CMV disease remains the most frequent infectious complication post-transplant and it is associated to high morbidity and even mortality. Global efforts from both transplant physicians and researchers in the field is needed to better characterize the host-virus interactions in the transplant setting, with the aim of decreasing the burden of disease and improve the well-being of patients.
"HORUS" (Casting light on HOst-cytomegaloviRUs interaction in Solid organ transplantation) study is a European research project, funded by the European Commission (Horizon Europe) involving 16 partners in seven European countries (France, Spain, Czech Republic, Belgium, Switzerland, Germany and Italy) aiming to better characterize the host-CMV interactions in SOT recipients. The first aim of HORUS study will be to build a European cohort of SOT recipients including clinical characterization and the constitution of a biocollection, which is the aim of HORUS cohort, in order to perform biological, immunological, gene expression, viral kinetics and deep viral genome characterization in the global European HORUS project to improve our understanding of the development of a CMV immune response in the context of immunosuppression.
Read the detailed description
The overall goal of HORUS study is to improve our understanding of the host-virus relationship of Cytomegalovirus within immunocompromised solid organ transplant recipients in order to propose both knowledge improvement, and clinical immune signatures for decreasing CMV infections/diseases incidence and avoiding the use of toxic antiviral therapy. HORUS' general goal is to enhance our knowledge on risk factors, disease progression and clinical outcomes by analyzing together immune host characteristics, viral characteristics and immunosuppressive drugs. The constitution of two clinical cohorts ("The day 0 of graft cohort" and "the day 0 of infection cohort") will constitute the aim of "HORUS study" with clinical data collection and biocollection which will be used in the global HORUS project to identify immune profiles of patients integrating all the actors involved in viral control, viral and clinical parameters associated with a higher risk of CMV replication and an evolution toward a CMV difficult-to-treat disease.
"HORUS cohorts" is a project of biological samples biobank from solid organ transplant recipients in Hospitals : France (Bordeaux, Toulouse, Paris, Lyon), Spain (Barcelona), Tchequie (Karlova), Italy (Bologna), Switzerland (Lausanne).
Its main objective of this protocol is to collect, prepare, and store
- under CRB conditions (NFS96900) longitudinal biological samples from solid organ transplants (heart, kidney, lung, liver), from day 0 of transplantation and followed for the occurrence of CMV infection.
- Clinical and sociodemographic data associated with this longitudinal biocollection
The secondary objective is to support for the global "HORUS" project aiming at:
- Studying the longitudinal clinical, viral and immunological profile of solid organ transplants after transplantation with or without CMV disease and if CMV disease with or without a "difficult-to-treat" (CMV persistence, relapse, antiviral drug resistance)
- Defining signatures combining virological data, clinical data, donor/recipient data and immune profile of CMV-specific immunity to identify :i) patients at risk of developing CMV infection and ii) at day 0 of infection to identify patient at risk of developing difficult-to-treat CMV infection. The collection of biological samples, associated with the clinico-biological data, to find the global signature constitutes an indispensable step.
- Keywords
- immunocompromised hosts, immune response
- Medical subject headings
- Cytomegalovirus Infections
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 |
|---|---|---|
| day 0 of transplantation | This cohort will include 450 patients at the time of transplantation. The following number of participants will be enrolled in the cohort according to strata defined by organ-transplanted type and baseline immune status. | |
| day 0 of infection | This cohort will include 150 patients at the time of the infection: Approximatively 75 patients will be drawn from the cohort of solid-organ transplant recipients included at day 0 of transplantation. Additional 75 patients developing a CMV infection will be also included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Measured: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : total volume
Measured: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies.
Measured: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : date of extraction
Measured: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Measured: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Measured: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : total volume
Measured: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies,
Measured: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : date of extraction,
Measured: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : total volume and concentration of DNA and RNA
Measured: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Measured: from day of infection (inclusion day) to month 12
Creation of a Clinical Database
Implementation of a centralized data base with clinical and sociodemographic data from all European clinical sites.
Measured: From inclusion day to month 36
Secondary outcomes (17)
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)
Measured: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)
Measured: From inclusion day to month 36
CMV caracterisation
Defining signatures combining virological data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Measured: From inclusion day to month 36
CMV caracterisation
Defining signatures combining clinical data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Measured: From inclusion day to month 36
CMV caracterisation
Defining signatures combining donor/recipient data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Measured: From inclusion day to month 36
CMV caracterisation
Defining signatures combining immune profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Measured: From inclusion day to month 36
CMV infection caracterisation
Defining signatures combining virological data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Measured: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Defining signatures combining clinical data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Measured: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Defining signatures combining donor/recipient data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Measured: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Defining signatures combining immune profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Measured: From day of infection (inclusion day) to month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start26 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies 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
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Laura RICHERT, Pr, Study chair, Clinical Epidemiology Unit at Bordeaux University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701228
- Sponsor's protocol ID
- CHUBX 2022/10
- Acronym
- HORUS
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT05701228
- Acronym / sponsor ID
- HORUS / CHUBX 2022/10
- Keywords
- immunocompromised hosts, immune response
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 552 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 2023 (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.
CMV disease remains the most frequent infectious complication post-transplant and it is associated to high morbidity and even mortality. Global efforts from both transplant physicians and researchers in the field is needed to better characterize the host-virus interactions in the transplant setting, with the aim of decreasing the burden of disease and improve the well-being of patients.
"HORUS" (Casting light on HOst-cytomegaloviRUs interaction in Solid organ transplantation) study is a European research project, funded by the European Commission (Horizon Europe) involving 16 partners in seven European countries (France, Spain, Czech Republic, Belgium, Switzerland, Germany and Italy) aiming to better characterize the host-CMV interactions in SOT recipients. The first aim of HORUS study will be to build a European cohort of SOT recipients including clinical characterization and the constitution of a biocollection, which is the aim of HORUS cohort, in order to perform biological, immunological, gene expression, viral kinetics and deep viral genome characterization in the global European HORUS project to improve our understanding of the development of a CMV immune response in the context of immunosuppression.
Detailed description
The overall goal of HORUS study is to improve our understanding of the host-virus relationship of Cytomegalovirus within immunocompromised solid organ transplant recipients in order to propose both knowledge improvement, and clinical immune signatures for decreasing CMV infections/diseases incidence and avoiding the use of toxic antiviral therapy. HORUS' general goal is to enhance our knowledge on risk factors, disease progression and clinical outcomes by analyzing together immune host characteristics, viral characteristics and immunosuppressive drugs. The constitution of two clinical cohorts ("The day 0 of graft cohort" and "the day 0 of infection cohort") will constitute the aim of "HORUS study" with clinical data collection and biocollection which will be used in the global HORUS project to identify immune profiles of patients integrating all the actors involved in viral control, viral and clinical parameters associated with a higher risk of CMV replication and an evolution toward a CMV difficult-to-treat disease.
"HORUS cohorts" is a project of biological samples biobank from solid organ transplant recipients in Hospitals : France (Bordeaux, Toulouse, Paris, Lyon), Spain (Barcelona), Tchequie (Karlova), Italy (Bologna), Switzerland (Lausanne).
Its main objective of this protocol is to collect, prepare, and store
- under CRB conditions (NFS96900) longitudinal biological samples from solid organ transplants (heart, kidney, lung, liver), from day 0 of transplantation and followed for the occurrence of CMV infection.
- Clinical and sociodemographic data associated with this longitudinal biocollection
The secondary objective is to support for the global "HORUS" project aiming at:
- Studying the longitudinal clinical, viral and immunological profile of solid organ transplants after transplantation with or without CMV disease and if CMV disease with or without a "difficult-to-treat" (CMV persistence, relapse, antiviral drug resistance)
- Defining signatures combining virological data, clinical data, donor/recipient data and immune profile of CMV-specific immunity to identify :i) patients at risk of developing CMV infection and ii) at day 0 of infection to identify patient at risk of developing difficult-to-treat CMV infection. The collection of biological samples, associated with the clinico-biological data, to find the global signature constitutes an indispensable step.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| day 0 of transplantation | – | –This cohort will include 450 patients at the time of transplantation. The following number of participants will be enrolled in the cohort according to strata defined by organ-transplanted type and baseline immune status. |
| day 0 of infection | – | –This cohort will include 150 patients at the time of the infection: Approximatively 75 patients will be drawn from the cohort of solid-organ transplant recipients included at day 0 of transplantation. Additional 75 patients developing a CMV infection will be also included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1 will include 450 patients at the time of transplantation: Kidney: 6 groups : 50 R+ATG no mTORi, 30 R+ATG mTORi, 50 R+ no ATG no mTORi, 30 R+ no ATG mTORi, 50 D+R- no mTORi, 30 D+R- mTORi Lung: 3 groups of 20 patients R+ ATG,R+ no ATG, D+R- Heart: 3 groups of 30 patients R+ ATG, R+ no ATG, D+R- Liver: 3 groups of 20 patients R+ ATG, R+ no ATG, D+R- Cohort 2 will include 150 patients at the time of the infection: Approximatively 75 patients are expected to roll-over from the cohort of solid-organ transplant recipients included at day 0 of transplantation (cohort 1). Additional 75 patients developing a CMV infection will be also included.
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Consecutive patients meeting the following inclusion criteria will be included:
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
Biobank inventory for cohort 1 : day 0 of transplantation
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Biobank inventory for cohort 1 : day 0 of transplantation
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory will be caracterise thanks to : total volume
Biobank inventory for cohort 1 : day 0 of transplantation
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies.
Biobank inventory for cohort 1 : day 0 of transplantation
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory will be caracterise thanks to : date of extraction
Biobank inventory for cohort 1 : day 0 of transplantation
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Biobank inventory for cohort 2 : day 0 of infection
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Biobank inventory for cohort 2 : day 0 of infection
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory will be caracterise thanks to : total volume
Biobank inventory for cohort 2 : day 0 of infection
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies,
Biobank inventory for cohort 2 : day 0 of infection
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory will be caracterise thanks to : date of extraction,
Biobank inventory for cohort 2 : day 0 of infection
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory will be caracterise thanks to : total volume and concentration of DNA and RNA
Biobank inventory for cohort 2 : day 0 of infection
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Creation of a Clinical Database
Time frame: From inclusion day to month 36
Implementation of a centralized data base with clinical and sociodemographic data from all European clinical sites.
17 secondary outcomes
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Time frame: From inclusion day to month 36
CMV caracterisation
Time frame: From inclusion day to month 36
CMV caracterisation
Time frame: From inclusion day to month 36
CMV caracterisation
Time frame: From inclusion day to month 36
CMV caracterisation
Time frame: From inclusion day to month 36
CMV infection caracterisation
Time frame: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Time frame: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Time frame: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Time frame: From day of infection (inclusion day) to month 36
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 27 Jan 2026.
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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.
Laura RICHERT, Pr study chair
Clinical Epidemiology Unit at Bordeaux University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and Solid Organ Transplantation, run by University Hospital, Bordeaux at 7 sites 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 0 inclusion and 14 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Biobank inventory for cohort 1 : day 0 of transplantation (time frame: from day of graft (inclusion day) to month 24). The study lists 12 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 27 Jan 2026.