Liver Transplant; ComplicationsPreLiveR-TNCT04246970

Prehabilitation and Posttransplant Training Program in Liver Transplantation

A study testing Prehabilitation and Prehabilitation and posttransplant training program in people with Liver Transplant; Complications and Cirrhosis, Liver, run by Maria dels Angels Cebria i Iranzo, PT, PhD at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Transplant; Complications, Cirrhosis, Liver, Hepatic Carcinoma
What is being tested?: Prehabilitation and Prehabilitation and posttransplant training program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSpain
Study dates: 1 Apr 2021to Jun 2026
Phase: Interventional
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

Who may be able to join

Indication of elective liver transplant with favorable cardiorespiratory evaluation that does not contraindicate the transplant.

Who cannot join

Any orthopedic, motor, functional, neurological, cognitive or linguistic limitation that prevents the realization of the Prehabilitation program
Inability to perform psychometric tests
Esophageal varices not treated with ligature or beta-blockers
Varicose veins with a high risk of digestive hemorrhage
Hemoglobin <80 g/l
Contraindication to weight loading

Show all 9Show fewer

Impossibility to comply with the Prehabilitation program (hospital admission, work, geographical location)
Multi-organ transplantation and liver retransplantation
Refusal or lacks capacity to give informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026

Other trials in Spain

About this study

Official title: Effects of a Prehabilitation Program in Liver Transplant Candidates Followed by a Posttransplant Training Program

PreLiveR-T consists of a prospective randomized clinical trial conducted in an adult population that is a candidate for liver transplantation (LT) at the Hospital La Fe Valencia (Spain). The study is structured in three phases: I) Prehabilitation (2 months before LT); II) Training, divided in two successive periods: Supervised training (months 3-6 after LT) and Unsupervised training (6-12 months after LT); III) Long-term follow-up (2 years after LT).

Primary outcomes are related to post-surgery evolution (morbidity and mortality, hospitalization length, etc.). As a secondary outcomes are collected those related to: functional capacity, muscle strength and quality of life.

Read the detailed description

The main objective is to study the post-surgical impact (post-S) of a Prehabilitation program on candidates for liver transplantation (LT), as well as to study the effects of posttransplant training on the clinical and functional evolution of the recipients. Also this project pretends to assess the influence of functional capacity (FC) improvement on the short and long term post-S evolution of the LT candidates. This is a prospective randomized clinical trial in which three phases follow: Prehabilitation, training and follow-up. The sample will be constituted by 60 candidates for LT, randomized in a control group (CG, n=20), a Prehabilitation group (PG, n=20) and a Prehabilitation-posttransplant training group (PTG, n=20). To conventional care, a Prehabilitation program will be added to the PG and PTG. After the LT, just PTG will follow a posttransplant training program. The long-term follow-up will be extended to 2 years post-LT. The variables under study will be: complications and post-S evolution; FC; quality of life; etc. The individualization of Prehabilitation and posttransplant training program, and also medical control, will ensure safety and offer the potential benefits that these types of programs can provide.

Conditions: Liver Transplant; Complications, Cirrhosis, Liver, Hepatic Carcinoma
Being tested: Prehabilitation, Prehabilitation and posttransplant training program
Keywords: Prehabilitation, Therapeutic Exercise, Functional capacity
Medical subject headings: Liver Cirrhosis, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrehabilitationOther
Also called Interval aerobic exercise, peripheral and respiratory muscle training, balance exercise
Supervised training program of 8-weeks and a frequency of 2 days/week. It includes interval aerobic exercise (5 cycles of 2 minutes at 70 percentage of Watts or heart rate of cardiopulmonary exercise testing (CEPT) and 3 minutes of active rest at 40 percentage; peripheral muscle training and balance exercises in a circuit of 10 phases, 10 to 15 repetitions, from 1 to 3 sets (the participants will work at moderate intensity, no more than 5-6/10 on the modified Borg scale); Inspiratory Muscle Training (IMT) through a threshold loading device [2 sessions / day, 3 sets of 15 repetitions, at 60-70 percentage of the maximum inspiratory pressure (cmH2O)]; ventilatory reeducation by an incentive inspirator based on the vital capacity evaluated in the initial spirometry. Both the aerobic modality and the resistance training, will increase the intensity of work (HR, Watts, Kg or cmH2O) between 2-5 percentage every 2 weeks complying with the principle of training overload.
Prehabilitation and posttransplant training programOther
Also called Interval aerobic exercise, peripheral muscle training and balance exercise
Prehabilitation will be followed by a posttransplant training program. In this, the patient will perform supervised exercise (IIa interval aerobic exercise and resistance training) 2 days / week, and a physical exercise program at home until completing a total of 5 sessions / week in the aerobic modality. In the unsupervised phase (IIb), the patient will continue with the learned physical exercise program, but without supervision, 5 sessions / week (including a minimum of 2 non-consecutive sessions to perform resistance training).

Study groups in NCT04246970
Study group	Role	What they receive
Control group	No intervention	Conventional medical care
Prehabilitation group	Experimental	Conventional medical care and 8 weeks of a Prehabilitation supervised program Receives: Other: Prehabilitation
Prehabilitation and posttransplant training group	Experimental	Conventional medical care, 8 weeks of a Prehabilitation supervised program and a posttransplant training program. Receives: Other: Prehabilitation; Other: Prehabilitation and posttransplant training program

What is being measured

The primary outcome is the main question the study is designed to answer.

Morbidity
Registry of post-surgical complications according to the Clavien-Dindo classification. Reference: Ann Surg 2004; 240(2):205-13.
Measured: The groups will be assessed from the hospitalization up to 24-months.
Mortality
Registry of mortality
Measured: The groups will be assessed from the hospitalization until the date of death, assessed up to 24-months.
Number of hospitalization days
Registry of number of days of hospitalization in intensive care unit and ward.
Measured: The groups will be assessed during hospitalization, approximately 7 days.
Number of days with supplementary oxygen therapy and/or mechanical ventilation
Registry of number of days
Measured: The groups will be assessed during hospitalization, approximately 7 days.
Progression in the activities of daily life (ADL)
Days of acquisition, sitting, walking and stairs
Measured: The groups will be assessed during hospitalization, approximately 7 days.

Secondary outcomes (7)

Change in functional capacity: measurement of oxygen uptake
Cardiopulmonary exercise test following an incremental protocol on ramp with a bicycle ergometer.
Measured: The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.
Change in functional capacity: 6-minutes walking test (6MWT)
6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis. American Thoracic Society (ATS) Statement Guidelines for the Six-Minute Walk Test. Am J Resp Crit Care Med 2002;166(1):111-117
Measured: The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.
Change in peripheral muscle strength: handgrip strength, quadriceps femoris strength and biceps brachii strength
Isometric peripheral muscle strength will be measured using a digital hand dynamometer and the unit of measure is kilograms. References:
Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall CC, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age and Ageing 2011;40(4):423-9.
Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996; 76(3):248-59
Measured: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
Change in respiratory strength: maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Maximum respiratory pressures will be measured using a Respiratory Pressure Meter MicroRPM® and the unit of measure is cmH2O. MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535
Measured: The groups will be assessed at baseline and at week 8.
Change in performance on the Short Physical Performance Battery (SPPB)
The SPPB is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines three areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. Static balance is measured in units of time (seconds) and patients are timed holding 3 different stances. Gait speed is measured in time (seconds) to walk 4 meters. Chair sits are measured as the time (seconds) it takes to get up and out of a chair 5 times without using one's arms to assist the exercise. Collectively, the three tests are used to generate a total score (0-12) that reflects a patient's frailty (score of 0) or lack of frailty (score of 12). Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49:M85-M94.
Measured: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
Change in muscle mass
Bioelectrical impedance analysis will be completed using the Bodystat 1500 MDD, which is a multi-frequency body composition analyzer. Body fat percentage (%) will be compared to lean body mass percentage and total body water percentage to assess sarcopenia and nutritional status.
Measured: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
Change in Quality of life
Short-Form Liver Disease Quality of Life (SF-LDQOL) is formed by 9 dimensions: symptoms of the disease, effects of the disease on the activities of daily life, memory/concentration, anxiety, sleep, loneliness, hopelessness, stigma for the disease and sexual functioning. The minimum and maximum values of the scale are 0-100, so that the higher the score, the better health related quality of life (HRQL).
Measured: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 2021Jun 2026

First posted29 Jan 2020
Study start1 Apr 2021
Primary completionJun 2026 (estimated)
Study completionJun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Liver Transplant; ComplicationsStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04246970
Sponsor's protocol ID: 2019/0227
Acronym: PreLiveR-T
Status last verified: Sep 2025
First submitted: 20 Jan 2020
Last updated: 15 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PubMed 28489682
Brustia R, Savier E, Scatton O. Physical exercise in cirrhotic patients: Towards prehabilitation on waiting list for liver transplantation. A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2018 Jun;42(3):205-215. doi: 10.1016/j.clinre.2017.09.005. Epub 2017 Nov 20.
PubMed 29162460
Debette-Gratien M, Tabouret T, Antonini MT, Dalmay F, Carrier P, Legros R, Jacques J, Vincent F, Sautereau D, Samuel D, Loustaud-Ratti V. Personalized adapted physical activity before liver transplantation: acceptability and results. Transplantation. 2015 Jan;99(1):145-50. doi: 10.1097/TP.0000000000000245.
PubMed 25531893
Williams FR, Vallance A, Faulkner T, Towey J, Durman S, Kyte D, Elsharkawy AM, Perera T, Holt A, Ferguson J, Lord JM, Armstrong MJ. Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. Liver Transpl. 2019 Jul;25(7):995-1006. doi: 10.1002/lt.25442. Epub 2019 Jun 6.
PubMed 30859755

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
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Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
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Not yet recruiting
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All Liver Transplant; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Prehabilitation Program in Liver Transplant Candidates Followed by a Posttransplant Training Program
ClinicalTrials.gov ID: NCT04246970
Acronym / sponsor ID: PreLiveR-T / 2019/0227
Conditions: Liver Transplant; Complications, Cirrhosis, Liver, Hepatic Carcinoma
Keywords: Prehabilitation, Therapeutic Exercise, Functional capacity
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 60 participants (estimated)
Lead sponsor: Maria dels Angels Cebria i Iranzo, PT, PhDUniversity, hospital or other
Collaborators: University of Valencia
Study start: 1 Apr 2021 (actual)
Primary completion: Jun 2026 (estimated)
Study completion: Jun 2026 (estimated)
First posted: 29 Jan 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Control group	No intervention	–Conventional medical care
Prehabilitation group	Experimental	Other: PrehabilitationConventional medical care and 8 weeks of a Prehabilitation supervised program
Prehabilitation and posttransplant training group	Experimental	Other: Prehabilitation, Other: Prehabilitation and posttransplant training programConventional medical care, 8 weeks of a Prehabilitation supervised program and a posttransplant training program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Indication of elective liver transplant with favorable cardiorespiratory evaluation that does not contraindicate the transplant.

Key exclusion criteria (9 listed)

Any orthopedic, motor, functional, neurological, cognitive or linguistic limitation that prevents the realization of the Prehabilitation program
Inability to perform psychometric tests
Esophageal varices not treated with ligature or beta-blockers
Varicose veins with a high risk of digestive hemorrhage
Hemoglobin <80 g/l

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
PrehabilitationAlso: Interval aerobic exercise, peripheral and respiratory muscle training, balance exerciseSupervised training program of 8-weeks and a frequency of 2 days/week. It includes interval aerobic exercise (5 cycles of 2 minutes at 70 percentage of Watts or heart rate of cardiopulmonary exercise testing (CEPT) and 3 minutes of active rest at 40 percentage; peripheral muscle training and balance exercises in a circuit of 10 phases, 10 to 15 repetitions, from 1 to 3 sets (the participants will work at moderate intensity, no more than 5-6/10 on the modified Borg scale); Inspiratory Muscle Training (IMT) through a threshold loading device [2 sessions / day, 3 sets of 15 repetitions, at 60-70 percentage of the maximum inspiratory pressure (cmH2O)]; ventilatory reeducation by an incentive inspirator based on the vital capacity evaluated in the initial spirometry. Both the aerobic modality and the resistance training, will increase the intensity of work (HR, Watts, Kg or cmH2O) between 2-5 percentage every 2 weeks complying with the principle of training overload.	Other	Prehabilitation and posttransplant training group, Prehabilitation group
Prehabilitation and posttransplant training programAlso: Interval aerobic exercise, peripheral muscle training and balance exercisePrehabilitation will be followed by a posttransplant training program. In this, the patient will perform supervised exercise (IIa interval aerobic exercise and resistance training) 2 days / week, and a physical exercise program at home until completing a total of 5 sessions / week in the aerobic modality. In the unsupervised phase (IIb), the patient will continue with the learned physical exercise program, but without supervision, 5 sessions / week (including a minimum of 2 non-consecutive sessions to perform resistance training).	Other	Prehabilitation and posttransplant training group

Primary outcome

Morbidity
Time frame: The groups will be assessed from the hospitalization up to 24-months.
Registry of post-surgical complications according to the Clavien-Dindo classification. Reference: Ann Surg 2004; 240(2):205-13.
Mortality
Time frame: The groups will be assessed from the hospitalization until the date of death, assessed up to 24-months.
Registry of mortality
Number of hospitalization days
Time frame: The groups will be assessed during hospitalization, approximately 7 days.
Registry of number of days of hospitalization in intensive care unit and ward.
Number of days with supplementary oxygen therapy and/or mechanical ventilation
Time frame: The groups will be assessed during hospitalization, approximately 7 days.
Registry of number of days
Progression in the activities of daily life (ADL)
Time frame: The groups will be assessed during hospitalization, approximately 7 days.
Days of acquisition, sitting, walking and stairs

7 secondary outcomes

Change in functional capacity: measurement of oxygen uptake
Time frame: The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.
Change in functional capacity: 6-minutes walking test (6MWT)
Time frame: The groups will be assessed at four times: at baseline; at week 8; 3-months after LT; and 6-months after LT.
Change in peripheral muscle strength: handgrip strength, quadriceps femoris strength and biceps brachii strength
Time frame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
Change in respiratory strength: maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Time frame: The groups will be assessed at baseline and at week 8.
Change in performance on the Short Physical Performance Battery (SPPB)
Time frame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
Change in muscle mass
Time frame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.
Change in Quality of life
Time frame: The groups will be assessed at six times: at baseline; at week 8; 1-month, 3-months, 6-months and 24-months after LT.

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 Sep 2025.
Background: PubMed 28489682Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
Background: PubMed 29162460Brustia R, Savier E, Scatton O. Physical exercise in cirrhotic patients: Towards prehabilitation on waiting list for liver transplantation. A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2018 Jun;42(3):205-215. doi: 10.1016/j.clinre.2017.09.005. Epub 2017 Nov 20.
Background: PubMed 25531893Debette-Gratien M, Tabouret T, Antonini MT, Dalmay F, Carrier P, Legros R, Jacques J, Vincent F, Sautereau D, Samuel D, Loustaud-Ratti V. Personalized adapted physical activity before liver transplantation: acceptability and results. Transplantation. 2015 Jan;99(1):145-50. doi: 10.1097/TP.0000000000000245.
Background: PubMed 30859755Williams FR, Vallance A, Faulkner T, Towey J, Durman S, Kyte D, Elsharkawy AM, Perera T, Holt A, Ferguson J, Lord JM, Armstrong MJ. Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study. Liver Transpl. 2019 Jul;25(7):995-1006. doi: 10.1002/lt.25442. Epub 2019 Jun 6.
Individual participant dataSharing planned: No

Related trials for Liver Transplant; Complications

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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
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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.

Maria A Cebrià i Iranzo, PT, PhD principal investigator

Hospital Universitari i Politècnic La Fe, Valencia

David Calatayud Mizrahi, MD, PhD study chair

Hospital Universitari i Politècnic La Fe, Valencia

Natalia Cezón Serrano, PT study chair

University of Valencia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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: enrolling by invitation, as of the sponsor's last update on 15 Sep 2025. 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 Spain. 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?

Morbidity (time frame: The groups will be assessed from the hospitalization up to 24-months.). The study lists 5 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 NCT04246970, which also lists 4 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 Sep 2025.