Lung Transplant RejectionINTERLUNGNCT02812290
Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation
An observational study of Lung Transplant Rejection, run by University of Alberta at 11 sites in 6 countries.
Trial summary
Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- Lung transplant biopsy bites.
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 11 sitesin 6 countries
- Study dates
- May 2016to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with functioning lung transplant biopsied to determine their graft dysfunction or to confirm good function as per standard of care.
Who may be able to join
- All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.
Who cannot join
- Patients who declined participation or unable to give informed consent.
Trial locations and contacts
11 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 6 countries
United States4 sites, 1 recruiting
- Completed
University of Maryland School of Medicine
Baltimore, Maryland, 21201
- Recruiting
St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT
Phoenix, Arizona, 85013
Chanti F Smith, 214-820-1771, chanti.smith@dignityhealth.org
Rajat Walia, MD
- Completed
University of Texas at San Antonio
San Antonio, Texas, 21201
- Completed
Division of Pulmonary and Critical Care, Washington University School of Medicine
St Louis, Missouri, 63110
Canada3 sites, 2 recruiting
- Recruiting
Alberta Transplant Applied Genomics Centre, University of Alberta
Edmonton, Alberta, T6G 2E1
Konrad S Famulski, PhD, 1 780 492 1725, konrad@ualberta.ca
Philip F Halloran, MD, PhD
- Recruiting
Department of Medicine, University of Alberta
Edmonton, Alberta, T6G 2G3
Kieran Halloran, MD, 1 780 492 2691, kieran.halloran@ualberta.ca
Kieran Halloran, MD
- Completed
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
Austria1 site
- Completed
Department of Thoracic Surgery, Medical University of Vienna
Vienna
Czechia1 site, 1 recruiting
- Recruiting
Charles University/Hospital Motol
Prague
Jan Havlin, Dr, havlin.jan@gmail.com
Jan Havlin, Dr
About this study
Official title: Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies
Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.
Read the detailed description
The current standard for biopsy-based diagnoses of dysfunction of lung transplants is the International Society of Heart and Lung Transplantation (ISHLT) classification applied to transbronchial biopsies, which represents an arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. especially in relationship to the correct diagnosis of chronic lung allograft dysfunction is a pressing need. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype. The MMDx, developed first in kidney transplant biopsies with thoroughly established phenotypes, will now be adapted to lung transplant transbronchial biopsies (TBBs). Microarray analysis of lung allograft biopsy specimens will be compared to conventional allograft phenotyping, including clinical, physiologic, radiographic and histological assessment. The present study will use the MMDx™ system to assess and report TBBs, and validate and refine this system in 300 unselected prospectively collected lung TBBs. A subset of the study will examine the third bifurcation mucosal endobronchial biopsies (3BMBs) paired with TBBs from 50 patients to see if the safer 3BMBs can substitute for the TBB to be used by MMDx™. Due to a considerable interest and support from participating Centers, the study is further extended and collected 1032 TBBs and 602 3BMBs from 849 patients. This this is the extension of the INTERLUNG study - INTERLUNGEX.
- Conditions
- Lung Transplant Rejection
- Being tested
- Lung transplant biopsy bites.
- Keywords
- antibody mediated rejection, T cell mediated rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung transplant biopsy bites.Procedure or surgery
In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability.
What is being measured
The primary outcome is the main question the study is designed to answer.
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.
Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
Measured: two years
Report the molecular diagnoses of the MMDx-TBB system
Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.
Measured: two years
Secondary outcomes (3)
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies.
Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
Measured: two years
Report the molecular diagnoses of the MMDx-3BMB system
Compare MMDx-3BMB readings to MMDx-TBB readings and clinical diagnosis of CLAD
Measured: two years
Report the molecular changes over time in medically indicated follow-up biopsies
Predict and monitor response to anti-rejection treatment.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Halloran, University of Alberta
- Investigators
- Philip F Halloran, MD, PhD, Principal investigator, Faculty of Medicine and Dentistry, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812290
- Sponsor's protocol ID
- ATAGC 03
- Acronym
- INTERLUNG
- Status last verified
- May 2026
- First submitted
- 31 May 2016
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
PubMed 38819301Halloran KM, Parkes MD, Chang J, Timofte IL, Snell GI, Westall GP, Hachem R, Kreisel D, Trulock E, Roux A, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. Molecular assessment of rejection and injury in lung transplant biopsies. J Heart Lung Transplant. 2019 May;38(5):504-513. doi: 10.1016/j.healun.2019.01.1317. Epub 2019 Feb 6.
PubMed 30773443Halloran K, Parkes MD, Timofte I, Snell G, Westall G, Havlin J, Lischke R, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Hirji A, Weinkauf J, Halloran PF. Molecular T-cell-mediated rejection in transbronchial and mucosal lung transplant biopsies is associated with future risk of graft loss. J Heart Lung Transplant. 2020 Dec;39(12):1327-1337. doi: 10.1016/j.healun.2020.08.013. Epub 2020 Aug 26.
PubMed 32943286Halloran K, Parkes MD, Timofte IL, Snell GI, Westall GP, Hachem R, Kreisel D, Levine D, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Hirji A, Weinkauf J, Halloran PF. Molecular phenotyping of rejection-related changes in mucosal biopsies from lung transplants. Am J Transplant. 2020 Apr;20(4):954-966. doi: 10.1111/ajt.15685. Epub 2019 Dec 1.
PubMed 31679176Parkes MD, Halloran K, Hirji A, Pon S, Weinkauf J, Timofte IL, Snell GI, Westall GP, Havlin J, Lischke R, Zajacova A, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. Transcripts associated with chronic lung allograft dysfunction in transbronchial biopsies of lung transplants. Am J Transplant. 2022 Apr;22(4):1054-1072. doi: 10.1111/ajt.16895. Epub 2021 Dec 16.
PubMed 34850543Halloran K, Mackova M, Parkes MD, Hirji A, Weinkauf J, Timofte IL, Snell GI, Westall GP, Lischke R, Zajacova A, Havlin J, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. The molecular features of chronic lung allograft dysfunction in lung transplant airway mucosa. J Heart Lung Transplant. 2022 Dec;41(12):1689-1699. doi: 10.1016/j.healun.2022.08.014. Epub 2022 Aug 27.
PubMed 36163162Gauthier PT, Mackova M, Hirji A, Weinkauf J, Timofte IL, Snell GI, Westall GP, Havlin J, Lischke R, Zajacova A, Simonek J, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran K, Halloran PF. Defining a natural killer cell-enriched molecular rejection-like state in lung transplant transbronchial biopsies. Am J Transplant. 2023 Dec;23(12):1922-1938. doi: 10.1016/j.ajt.2023.06.003. Epub 2023 Jun 7.
PubMed 37295720Mackova M, Gauthier P, Chang J, Hirji A, Weinkauf J, Juvet S, Keshavjee S, Havlin J, Lischke R, Zajacova A, Snell G, Westall G, Halloran PF, Halloran K. Molecular biopsy features associated with baseline lung allograft dysfunction in a multicenter international cohort. J Heart Lung Transplant. 2026 Mar;45(3):403-414. doi: 10.1016/j.healun.2025.11.005. Epub 2025 Nov 14.
PubMed 41242356Gauthier PT, Mackova M, Hachem R, Havlin J, Hirji A, Jaksch P, Juvet S, Keshavjee S, Kovacs Z, Kreisel D, Kubisa B, Levine DJ, Lischke R, Piotrowska M, Simonek J, Timofte I, van den Bosch L, Snell G, Westall G, Zajacova A, Halloran K, Halloran PF. Molecular diagnosis of T cell-mediated rejection in bronchial mucosal and transbronchial biopsies. Am J Transplant. 2026 Sep 25:S1600-6135(26)02793-0. doi: 10.1016/j.ajt.2026.09.032. Online ahead of print.
PubMed 42790594Gauthier PT, Gerhardt LM, Jahn L, Hinze C, Halloran PF. Digital cytometry of leukocyte landscapes reveals shared correlates of rejection across organ transplants. J Clin Invest. 2026 Sep 22:e208686. doi: 10.1172/JCI208686. Online ahead of print.
PubMed 42771484Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.
PubMed 33595110
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies
- ClinicalTrials.gov ID
- NCT02812290
- Acronym / sponsor ID
- INTERLUNG / ATAGC 03
- Conditions
- Lung Transplant Rejection
- Keywords
- antibody mediated rejection, T cell mediated rejection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jun 2016 (estimated)
- 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.
Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.
Detailed description
The current standard for biopsy-based diagnoses of dysfunction of lung transplants is the International Society of Heart and Lung Transplantation (ISHLT) classification applied to transbronchial biopsies, which represents an arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. especially in relationship to the correct diagnosis of chronic lung allograft dysfunction is a pressing need. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype. The MMDx, developed first in kidney transplant biopsies with thoroughly established phenotypes, will now be adapted to lung transplant transbronchial biopsies (TBBs). Microarray analysis of lung allograft biopsy specimens will be compared to conventional allograft phenotyping, including clinical, physiologic, radiographic and histological assessment. The present study will use the MMDx™ system to assess and report TBBs, and validate and refine this system in 300 unselected prospectively collected lung TBBs. A subset of the study will examine the third bifurcation mucosal endobronchial biopsies (3BMBs) paired with TBBs from 50 patients to see if the safer 3BMBs can substitute for the TBB to be used by MMDx™. Due to a considerable interest and support from participating Centers, the study is further extended and collected 1032 TBBs and 602 3BMBs from 849 patients. This this is the extension of the INTERLUNG study - INTERLUNGEX.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with functioning lung transplant biopsied to determine their graft dysfunction or to confirm good function as per standard of care.
Key inclusion criteria (1 listed)
- All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.
Key exclusion criteria (1 listed)
- Patients who declined participation or unable to give informed consent.
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 |
|---|---|---|
| Lung transplant biopsy bites.In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability. | Procedure or surgery | – |
Primary outcome
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.
Time frame: two years
Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
Report the molecular diagnoses of the MMDx-TBB system
Time frame: two years
Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.
3 secondary outcomes
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies.
Time frame: two years
Report the molecular diagnoses of the MMDx-3BMB system
Time frame: two years
Report the molecular changes over time in medically indicated follow-up biopsies
Time frame: two years
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 28 May 2026.
- Background: PubMed 38819301Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
- Results publication: PubMed 30773443Halloran KM, Parkes MD, Chang J, Timofte IL, Snell GI, Westall GP, Hachem R, Kreisel D, Trulock E, Roux A, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. Molecular assessment of rejection and injury in lung transplant biopsies. J Heart Lung Transplant. 2019 May;38(5):504-513. doi: 10.1016/j.healun.2019.01.1317. Epub 2019 Feb 6.
- Results publication: PubMed 32943286Halloran K, Parkes MD, Timofte I, Snell G, Westall G, Havlin J, Lischke R, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Hirji A, Weinkauf J, Halloran PF. Molecular T-cell-mediated rejection in transbronchial and mucosal lung transplant biopsies is associated with future risk of graft loss. J Heart Lung Transplant. 2020 Dec;39(12):1327-1337. doi: 10.1016/j.healun.2020.08.013. Epub 2020 Aug 26.
- Results publication: PubMed 31679176Halloran K, Parkes MD, Timofte IL, Snell GI, Westall GP, Hachem R, Kreisel D, Levine D, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Hirji A, Weinkauf J, Halloran PF. Molecular phenotyping of rejection-related changes in mucosal biopsies from lung transplants. Am J Transplant. 2020 Apr;20(4):954-966. doi: 10.1111/ajt.15685. Epub 2019 Dec 1.
- Results publication: PubMed 34850543Parkes MD, Halloran K, Hirji A, Pon S, Weinkauf J, Timofte IL, Snell GI, Westall GP, Havlin J, Lischke R, Zajacova A, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. Transcripts associated with chronic lung allograft dysfunction in transbronchial biopsies of lung transplants. Am J Transplant. 2022 Apr;22(4):1054-1072. doi: 10.1111/ajt.16895. Epub 2021 Dec 16.
- Results publication: PubMed 36163162Halloran K, Mackova M, Parkes MD, Hirji A, Weinkauf J, Timofte IL, Snell GI, Westall GP, Lischke R, Zajacova A, Havlin J, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. The molecular features of chronic lung allograft dysfunction in lung transplant airway mucosa. J Heart Lung Transplant. 2022 Dec;41(12):1689-1699. doi: 10.1016/j.healun.2022.08.014. Epub 2022 Aug 27.
- Results publication: PubMed 37295720Gauthier PT, Mackova M, Hirji A, Weinkauf J, Timofte IL, Snell GI, Westall GP, Havlin J, Lischke R, Zajacova A, Simonek J, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran K, Halloran PF. Defining a natural killer cell-enriched molecular rejection-like state in lung transplant transbronchial biopsies. Am J Transplant. 2023 Dec;23(12):1922-1938. doi: 10.1016/j.ajt.2023.06.003. Epub 2023 Jun 7.
- Results publication: PubMed 41242356Mackova M, Gauthier P, Chang J, Hirji A, Weinkauf J, Juvet S, Keshavjee S, Havlin J, Lischke R, Zajacova A, Snell G, Westall G, Halloran PF, Halloran K. Molecular biopsy features associated with baseline lung allograft dysfunction in a multicenter international cohort. J Heart Lung Transplant. 2026 Mar;45(3):403-414. doi: 10.1016/j.healun.2025.11.005. Epub 2025 Nov 14.
- Derived from this study: PubMed 42790594Gauthier PT, Mackova M, Hachem R, Havlin J, Hirji A, Jaksch P, Juvet S, Keshavjee S, Kovacs Z, Kreisel D, Kubisa B, Levine DJ, Lischke R, Piotrowska M, Simonek J, Timofte I, van den Bosch L, Snell G, Westall G, Zajacova A, Halloran K, Halloran PF. Molecular diagnosis of T cell-mediated rejection in bronchial mucosal and transbronchial biopsies. Am J Transplant. 2026 Sep 25:S1600-6135(26)02793-0. doi: 10.1016/j.ajt.2026.09.032. Online ahead of print.
- Derived from this study: PubMed 42771484Gauthier PT, Gerhardt LM, Jahn L, Hinze C, Halloran PF. Digital cytometry of leukocyte landscapes reveals shared correlates of rejection across organ transplants. J Clin Invest. 2026 Sep 22:e208686. doi: 10.1172/JCI208686. Online ahead of print.
- Derived from this study: PubMed 33595110Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.
- 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.
Philip F Halloran, MD, PhD principal investigator
Faculty of Medicine and Dentistry, University of Alberta
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Rejection, run by University of Alberta at 11 sites in 6 countries.
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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada, Australia, Austria, Czechia and 1 more country. 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 Konrad S Famulski, PhD (1 780 492 1725, konrad@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies. (time frame: two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812290, which also lists 11 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 28 May 2026.