Bronchiolitis ObliteransPhase 1STOP-BOSNCT03315741
The Safety and Tolerability of Pirfenidone for BOS After HCT
A Phase 1 study testing Pirfenidone 267 MG [Esbriet] in people with Bronchiolitis Obliterans and Graft Vs Host Disease, run by Stanford University at 1 site in United States.
Trial summary
This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans, Graft Vs Host Disease
- What is being tested?
- Pirfenidone 267 MG [Esbriet]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 27 Apr 2022
- Phase
- Phase 1
- 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
- Age > 18 years at randomization
- Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ≥ 2 months duration
- Presence of cGVHD in an organ other than lung
- Subjects must have had recent pulmonary function test (PFTs) measured for at least 3 months prior to study enrollment that show:
- A decrease in %FVC and/or %FEV1 ≥ 20% at Screening compared with pre-transplant baseline.
- Bronchodilator response on PFT testing that results in an FEV1 < 75%
Show all 15Show fewer
- Diagnosis of BOS by one of the following criteria:
- Transbronchial or surgical lung biopsy demonstrating the obliterative bronchiolitis lesion
- Volumetric CT scan with lung density analysis with ≥ 28% air trapping (1).
- NIH-based PFT criteria for the diagnosis of BOS: FEV1/FVC <0.7 and FEV1 < 75%
- Evidence of clinical improvement after treatment for BOS has been initiated.
- No features supporting an alternative diagnosis by transbronchial biopsy, bronchoalveolar lavage (BAL), surgical lung biopsy, culture and non-culture based data, if performed
- Adequate organ and marrow function including: liver function as defined by a total bilirubin below the upper limit of normal (ULN), excluding patients with Gilbert's syndrome; AST/SGOT or ALT/SGPT < 3 x ULN; alkaline phosphatase < 2.5 x ULN; renal function as defined by a CrCl > 30 mL/min, calculated using the Cockcroft-Gault formula; cardiac electrophysiologic stability as defined by an electrocardiogram (ECG) with a QTc interval < 500 msec at Screening; and bone marrow function as defined by a white blood cell count > 3 K/µL, an absolute neutrophil count > 15 K/µL and a platelet count > 20 K/µL
- Life expectancy > 6 months
- Participants must be able to understand and sign a written informed consent form and understand the importance of adherence to study treatment and protocol. In addition, participants must demonstrate a willingness to follow all study requirements, including the concomitant medication restrictions, throughout the study
Who cannot join
- Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone e.g., presence of active GVHD of the gastrointestinal tract as manifested by rising liver function tests (LFTs) prior to initiation of study treatment
- Uncontrolled infection
- Major surgery within the past 2 months
- The use of another investigational drug within the previous 30 days.
- Inability to attend scheduled clinic visits
- Inability to perform pulmonary function testing
Show all 23Show fewer
- Significant clinical change in health in the past 30 days
- Body mass index (BMI) < 17.5
- Life expectancy < 6 months due to any condition other than BOS that, in the opinion of the investigator, is likely to result in the death of the patient.
- History of unstable or deteriorating cardiac or pulmonary disease (other than BOS) within the previous 6 months, including but not limited to the following:
- Unstable angina pectoris or myocardial infarction
- Congestive heart failure requiring hospitalization
- Uncontrolled clinically significant arrhythmias
- Pregnancy or lactation.
- Family or personal history of long QT syndrome
- Investigational therapy, defined as any drug that has not been approved for marketing for any indication in cGVHD will be restricted from the study
- The following medications may significantly increase the level of Pirfenidone and should not be taken concurrently including: fluvoxamine, ciprofloxacin > 500mg twice daily, systemically administered aminolevulinic acid, vemurafenib and enoxacin. Any other strong inhibitors of P450 isoenzymes CYP1A2, CYP2C9, 2C19, 2D6, and 2E1 should be avoided. Participants that cannot take alternative medications to those listed above will be excluded from this study.
- Laboratory Exclusions
- Any of the following LFT criteria above specified limits: total bilirubin above the upper limit of normal (ULN), excluding patients with Gilbert's syndrome; aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) >3 × ULN; alkaline phosphatase >2.5 × ULN
- Creatinine clearance (CrCl) <30 mL/min, calculated using the Cockcroft-Gault formula
- Electrocardiogram (ECG) with a QTc interval >500 msec at Screening
- Medication Exclusions
- 1. Prior use of pirfenidone or known hypersensitivity to any of the components of study treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Official title: The Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell Transplantation
This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant.
Read the detailed description
This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant (HCT). Such a trial is a necessary step prior to an evaluation of efficacy, as pirfenidone is known to be associated with adverse events (AEs) of the liver, gastrointestinal system and skin, organs frequently affected in GVHD. Approximately 30 patients will be enrolled, all patients will follow the same drug titration approach. The primary endpoint will be drug tolerability as measured by: the number of patients that are able to maintain the recommended dose of pirfenidone (2403 mg/d) without dose reduction lasting more than 21 days, due to adverse events (AEs). Changes from Baseline to Week 52 will be studied using validated health-related quality of life scales. Eligible patients aged > 18 years must have a diagnosis of BOS according to pre-specified criteria. Patients will be required to have an %FEV1 or %FVC decline >20% from pre-transplant baseline and symptoms of dyspnea, or cough. Eligible patients will enter the Screening Period, which may last up to 28 days. The dose of pirfenidone will be titrated over 3-8 weeks. Patients will have a telephone assessment at Week 1 and 2. An in-clinic assessment will occur every 1-3 months as part of their usual clinical care in the Stanford University Lung GVHD clinic. Patients will complete an AE and dosing compliance diary. If patients discontinue study treatment early for any reason, they will continue with all scheduled study procedures through Week 52. All deaths will be reviewed by a Mortality Assessment Committee (MAC). An external Data Safety Monitoring Board (DSMB) will monitor patient safety during the study.
- Conditions
- Bronchiolitis Obliterans, Graft Vs Host Disease
- Being tested
- Pirfenidone 267 MG [Esbriet]
- Keywords
- Bronchiolitis obliterans syndrome
- Medical subject headings
- Bronchiolitis Obliterans, Graft vs Host Disease, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone 267 MG [Esbriet]Drug
Tolerability of drug
| Study group | Role | What they receive |
|---|---|---|
| Patient centered approach | Experimental | Drug titration of maximum dose over 3-8 weeks Receives: Drug: Pirfenidone 267 MG [Esbriet] |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants that do not require a reduction in drug dose for more than 21 days due to adverse events.
We will count the number of participants that do not require a reduction in drug dose of more than 21, non-continuous days due to adverse events. Tolerability will be assessed during continuous treatment. If the medication dosage increase results in the reoccurrence of a moderate adverse event or serious adverse event, lasting more than 21 days, then the event would be defined as "not tolerated". If adverse events resolve before 21 days, then participants will attempt to again up-titrate the Pirfenidone dose, as tolerated. If at least 25% of participants tolerate the drug, then investigators will deem that this study demonstrates adequate tolerability to proceed to a larger trial to examine drug efficacy.
Measured: 52 weeks
Secondary outcomes (14)
The number of participants that permanently discontinue drug due to adverse events.
We will count the number of patients that permanently discontinue Pirfenidone due to adverse events. A permanent discontinuation of drug is defined as discontinuation of the drug for more than 42 days.
Measured: 52 weeks
The number of participants that temporarily discontinue drug due to adverse events.
We will count the number of participants that temporarily discontinue Pirfenidone due to adverse events. A temporary discontinuation of drug is defined as discontinuation of the drug for less than or equal to 42 days.
Measured: 52 week
The number of patients that experience treatment-emergent adverse events
Treatment emergent events are defined as those that start or worsen after the start of study treatment and up to 28 days after the last dose of study treatment. AEs will be summarized by treatment group, system organ class, and preferred term, and also by the event's relationship to study treatment. At each level of summation, patients will be counted only once, under the greatest severity and strongest study-drug relationship (as reported by the investigator).
Measured: 56 week
The number of patients that experience treatment-emergent serious adverse events (SAEs)
Serious adverse events (SAEs) are defined as those that result in: (i) death or are life threatening; (ii) result in hospitalization or prolong hospitalization; or (iii) result in disability (disruption of the participant's ability to conduct normal daily activities). Serious adverse events will be summarized by treatment group, system organ class, and preferred term, and also by the event's relationship to study treatment. At each level of summation, patients will be counted only once, under the greatest severity and strongest study-drug relationship (as reported by the investigator).
Measured: 56 week
The number of patients that experience treatment-emergent deaths during the study period and for 28 days after the last dose of study treatment.
Treatment emergent deaths are defined as those that occur after the start of study treatment and up to 28 days after the last dose of study treatment and are deemed by the investigator to be related to study treatment.
Measured: 56 week
All-cause mortality
We will count the total number of deaths during the study period and for 28 days after the last dose of study treatment
Measured: 56 week
The number of patients that experience treatment-emergent changes in complete blood counts.
The complete blood count measures the number white blood cells (WBCs) per liter (L) including differential counts of the type of WBCs, hemoglobin concentration (g/dL), and platelet count per liter.
Measured: 52 week
The number of patients that experience treatment-emergent changes in liver function testing.
We will assess treatment related changes in total bilirubin (mg/dL), AST/SGOT (units/L) or ALT/SGPT (units/L), alkaline phosphatase (units/L)
Measured: 52 week
The number of patients that experience treatment-emergent changes in serum chemistries panel.
We will assess treatment related changes in potassium (mEq/L), blood urea nitrogen (mg/dL) and serum creatinine (mg/dL).
Measured: 52 week
The number of patients that experience treatment-emergent changes in the corrected QT-interval on electrocardiogram.
We will evaluate changes in the interval from ventricular depolarization (Q-wave) to ventricular repolarization (T-wave) corrected for by heart rate
Measured: 52 week
Body mass index
We will measure changes in the participant's height (meters) and weight (kg) to determine changes in body mass index (kg/m^2)
Measured: 52 week
Oxygen saturation
We will measure the participant's oxygen saturation (%) at rest on room air.
Measured: 52 week
Heart rate
We will measure the participant's resting heart rate (beats per minute)
Measured: 52 week
Chronic GVHD assessment
Chronic GVHD symptoms will be assessed according to NIH cGVHD global severity score. The global cGVHD severity score evaluates the severity of cGVHD in eight sites including the skin, mouth, eyes, gastrointestinal track, liver, lungs, joints and fascia, and genital track. Each organ is assigned a severity score and composite scores are calculated based on the number of organs involved and the severity score within each affected organ.
Measured: 56 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Mar 2018
- Primary completion27 Feb 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase 1, non-randomized, single arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant (HCT). Approximately 30 patients will be enrolled. All patients will follow the 'patient-centered' drug titration approach.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Joe L Hsu, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315741
- Sponsor's protocol ID
- IRB-43319
- Other IDs
- VAR0158
- Acronym
- STOP-BOS
- Status last verified
- Jun 2022
- First submitted
- 5 Oct 2017
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharifi H, Moss CT, Musa Z, Bell A, O'Donnell C, Borges CH, Matthaiou EI, Johnston L, Galban CJ, Sheshadri A, Yanik G, Cheng GS, Hsu JL. Pirfenidone for the treatment of bronchiolitis obliterans syndrome related to chronic graft-versus-host disease. Blood Adv. 2025 Oct 14;9(19):5024-5037. doi: 10.1182/bloodadvances.2025016122.
PubMed 40554417Matthaiou EI, Sharifi H, O'Donnell C, Chiu W, Owyang C, Chatterjee P, Turk I, Johnston L, Brondstetter T, Morris K, Cheng GS, Hsu JL. The safety and tolerability of pirfenidone for bronchiolitis obliterans syndrome after hematopoietic cell transplant (STOP-BOS) trial. Bone Marrow Transplant. 2022 Aug;57(8):1319-1326. doi: 10.1038/s41409-022-01716-4. Epub 2022 May 31.
PubMed 35641662
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT03315741
- Acronym / sponsor ID
- STOP-BOS / IRB-43319
- Conditions
- Bronchiolitis Obliterans, Graft Vs Host Disease
- Keywords
- Bronchiolitis obliterans syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant.
Detailed description
This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant (HCT). Such a trial is a necessary step prior to an evaluation of efficacy, as pirfenidone is known to be associated with adverse events (AEs) of the liver, gastrointestinal system and skin, organs frequently affected in GVHD. Approximately 30 patients will be enrolled, all patients will follow the same drug titration approach. The primary endpoint will be drug tolerability as measured by: the number of patients that are able to maintain the recommended dose of pirfenidone (2403 mg/d) without dose reduction lasting more than 21 days, due to adverse events (AEs). Changes from Baseline to Week 52 will be studied using validated health-related quality of life scales. Eligible patients aged > 18 years must have a diagnosis of BOS according to pre-specified criteria. Patients will be required to have an %FEV1 or %FVC decline >20% from pre-transplant baseline and symptoms of dyspnea, or cough. Eligible patients will enter the Screening Period, which may last up to 28 days. The dose of pirfenidone will be titrated over 3-8 weeks. Patients will have a telephone assessment at Week 1 and 2. An in-clinic assessment will occur every 1-3 months as part of their usual clinical care in the Stanford University Lung GVHD clinic. Patients will complete an AE and dosing compliance diary. If patients discontinue study treatment early for any reason, they will continue with all scheduled study procedures through Week 52. All deaths will be reviewed by a Mortality Assessment Committee (MAC). An external Data Safety Monitoring Board (DSMB) will monitor patient safety during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase 1, non-randomized, single arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant (HCT). Approximately 30 patients will be enrolled. All patients will follow the 'patient-centered' drug titration approach.
| Arm | Type | Receives |
|---|---|---|
| Patient centered approach | Experimental | Drug: Pirfenidone 267 MG [Esbriet]Drug titration of maximum dose over 3-8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age > 18 years at randomization
- Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ≥ 2 months duration
- Presence of cGVHD in an organ other than lung
- Subjects must have had recent pulmonary function test (PFTs) measured for at least 3 months prior to study enrollment that show:
- Diagnosis of BOS by one of the following criteria:
Key exclusion criteria (23 listed)
- Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone e.g., presence of active GVHD of the gastrointestinal tract as manifested by rising liver function tests (LFTs) prior to initiation of study treatment
- Uncontrolled infection
- Major surgery within the past 2 months
- The use of another investigational drug within the previous 30 days.
- Inability to attend scheduled clinic visits
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 |
|---|---|---|
| Pirfenidone 267 MG [Esbriet]Tolerability of drug | Drug | Patient centered approach |
Primary outcome
The number of participants that do not require a reduction in drug dose for more than 21 days due to adverse events.
Time frame: 52 weeks
We will count the number of participants that do not require a reduction in drug dose of more than 21, non-continuous days due to adverse events. Tolerability will be assessed during continuous treatment. If the medication dosage increase results in the reoccurrence of a moderate adverse event or serious adverse event, lasting more than 21 days, then the event would be defined as "not tolerated". If adverse events resolve before 21 days, then participants will attempt to again up-titrate the Pirfenidone dose, as tolerated. If at least 25% of participants tolerate the drug, then investigators will deem that this study demonstrates adequate tolerability to proceed to a larger trial to examine drug efficacy.
14 secondary outcomes
The number of participants that permanently discontinue drug due to adverse events.
Time frame: 52 weeks
The number of participants that temporarily discontinue drug due to adverse events.
Time frame: 52 week
The number of patients that experience treatment-emergent adverse events
Time frame: 56 week
The number of patients that experience treatment-emergent serious adverse events (SAEs)
Time frame: 56 week
The number of patients that experience treatment-emergent deaths during the study period and for 28 days after the last dose of study treatment.
Time frame: 56 week
All-cause mortality
Time frame: 56 week
The number of patients that experience treatment-emergent changes in complete blood counts.
Time frame: 52 week
The number of patients that experience treatment-emergent changes in liver function testing.
Time frame: 52 week
The number of patients that experience treatment-emergent changes in serum chemistries panel.
Time frame: 52 week
The number of patients that experience treatment-emergent changes in the corrected QT-interval on electrocardiogram.
Time frame: 52 week
Body mass index
Time frame: 52 week
Oxygen saturation
Time frame: 52 week
Heart rate
Time frame: 52 week
Chronic GVHD assessment
Time frame: 56 week
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 13 Jun 2022.
- Derived from this study: PubMed 40554417Sharifi H, Moss CT, Musa Z, Bell A, O'Donnell C, Borges CH, Matthaiou EI, Johnston L, Galban CJ, Sheshadri A, Yanik G, Cheng GS, Hsu JL. Pirfenidone for the treatment of bronchiolitis obliterans syndrome related to chronic graft-versus-host disease. Blood Adv. 2025 Oct 14;9(19):5024-5037. doi: 10.1182/bloodadvances.2025016122.
- Derived from this study: PubMed 35641662Matthaiou EI, Sharifi H, O'Donnell C, Chiu W, Owyang C, Chatterjee P, Turk I, Johnston L, Brondstetter T, Morris K, Cheng GS, Hsu JL. The safety and tolerability of pirfenidone for bronchiolitis obliterans syndrome after hematopoietic cell transplant (STOP-BOS) trial. Bone Marrow Transplant. 2022 Aug;57(8):1319-1326. doi: 10.1038/s41409-022-01716-4. Epub 2022 May 31.
- Individual participant dataSharing planned: No
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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.
Joe L Hsu, MD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pirfenidone 267 MG [Esbriet] in people with Bronchiolitis Obliterans and Graft Vs Host Disease, run by Stanford University at 1 site in United States.
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 15 inclusion and 23 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 13 Jun 2022. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number of participants that do not require a reduction in drug dose for more than 21 days due to adverse events. (time frame: 52 weeks). 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 NCT03315741, which also lists 2 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 13 Jun 2022.