Pulmonary FibrosisPhase 2PIRFENIVASNCT03385668
Pilot Study of Pirfenidone in Pulmonary Fibrosis With Anti-myeloperoxydase Antibodies
A Phase 2 study testing Pirfenidone in people with Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine wether pirfenidone is safe and effective in the treatment of pulmonary fibrosis with anti-myeloperoxydase (MPO) antibodies or pulmonary fibrosis with anti-MPO associated vasculitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- Pirfenidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2018to 24 Jul 2020
- Phase
- Phase 2
- 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
- Presence of anti-MPO antibody (ELISA) at inclusion or during pulmonary fibrosis follow-up and/or diagnosis of anti-MPO associated vasculitis according to the 2012 Revised International Chapel Hill Consensus Conference definitions
- Definite or possible Usual Interstitial Pneumonia or Non Specific Interstitial Pneumonia based on high-resolution computed tomography
- Presence of pulmonary fibrosis, defined as a range of 50 to 90% of the %FVC and a range of 30 to 90% of the %DLCO
- Pulmonary fibrosis refractory (according to the investigator's judgment) to a conventional regimen used for anti-MPO associated vasculitis when a treatment against vasculitis has been used
- Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information) and comply with the study protocol procedures (including required study visits)
- Have affiliation with a mode of social security (profit our being entitled).
Who cannot join
- Other type of systemic vasculitis;
- Active vasculitis defined by Birmingham Vasculitis Activity Score >3 (BVAS) ;
- Contraindication to Pirfenidone;
- Unable to perform pulmonary function test (PFT);
- Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study : implants of levonorgestrel; injectable progesterone; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progesterone only); double barrier method (condom, cervical cap or diaphragm with spermicidal agent); transdermal contraceptive patch; male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject;
- Any of the following liver function test criteria above specified limits: total bilirubin above 1,5 times the upper limit of normal (ULN), excluding patients with Gilbert's syndrome; aspartate (AST)/Glutamate Oxaloacétique Transaminase (SGOT) or alanine aminotransferase (ALT)/Glutamate Pyruvate Transaminase (SGPT), (AST/SGOT or ALT/SGPT) >3 × ULN; alkaline phosphatase >2.5 × ULN;
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- Creatinine clearance (CrCl<30) mL/min, calculated using the Cockcroft-Gault formula at screening
- Current treatment with Nintedanib or past treatment with Nintedanib in the last 12 months;
- Current treatment with Fluvoxamine or past treatment with Fluvoxamine in the last 28 days before screening
- Prior use of Pirfenidone or known hypersensitivity to any of the components of study treatment;
- Expected to receive a lung transplant within 1 year from randomization or, on a lung transplant waiting list at randomization;
- Associated connective tissue disease (such as systemic sclerosis).;
- Electrocardiogram (ECG), with a heart-rate-corrected QT interval (corrected using Fridericia's formula, QTcF) ≥ 500 ms at Screening, or a family or personal history of long QT syndrome;
- Treatment with Cyclophosphamide in the last 3 months;
- Current smoking or past smoking in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Pulmonary Fibrosis With Anti-myeloperoxydase (MPO) Antibodies or With Anti-MPO Associated Vasculitis."
The purpose of this study is to determine wether pirfenidone is safe and effective in the treatment of pulmonary fibrosis with anti-myeloperoxydase (MPO) antibodies or pulmonary fibrosis with anti-MPO associated vasculitis.
Read the detailed description
Pulmonary fibrosis can be associated with Anti-Neutrophil Cytoplasmic Antibody (ANCA) directed against MPO or with anti-MPO associated vasculitis, leading to increased disability and poor prognosis. The pathophysiology of this association remains unclear. Conventional therapies used for the treatment of vasculitis manifestations are often disappointing for the treatment of pulmonary fibrosis. The main cause of death in patients with anti-MPO ANCA associated vasculitis and associated pulmonary fibrosis is the progression of pulmonary fibrosis. No treatment has demonstrated efficacy to stabilize or improve pulmonary fibrosis associated with anti-MPO associated vasculitis.
Previous studies showed that Pirfenidone improves survival and pulmonary function in patients with idiopathic pulmonary fibrosis (IPF) and that Pirfenidone treatment is safe and well tolerated in IPF. Patients with anti-MPO associated vasculitis (or anti-MPO antibodies without vasculitis) and associated pulmonary fibrosis might benefit from the use of Pirfenidone. However, the efficacy and safety of pirfenidone in patients with anti-MPO associated vasculitis and associated pulmonary fibrosis has not been evaluated. This study was designed to assess the efficacy and safety of pirfenidone in patients with pulmonary fibrosis and anti-MPO ANCA associated vasculitis or anti-MPO antibodies without vasculitis.
- Conditions
- Pulmonary Fibrosis
- Being tested
- Pirfenidone
- Keywords
- Pulmonary fibrosis, Antibodies, Antineutrophil Cytoplasmic, Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis, Pirfenidone, Microscopic Polyangiitis, Interstitial lung disease
- Medical subject headings
- Pulmonary Fibrosis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Microscopic Polyangiitis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Pirfenidone at a dose of 2403 mg/day for 50 weeks, after a 2 weeks period of titration (801 mg/day for one week then 1602 mg/day for one week).
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone | Experimental | All patients will receive Pirfenidone Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy measured by the absolute change in percent predicted forced vital capacity (%FVC)
Treatment efficacy at Week 52 measured by the absolute change from baseline to Week 52 in percent predicted forced vital capacity (%FVC) :
- Patients with progressive disease will be defined as absolute decline of 10% or more in %FVC. Missing values or death will be also considered as progressive.
- Patients with non-progressive disease will be defined as improvement or no decline in %FVC or a decline of %FVC<10%.
Measured: 52 weeks
Secondary outcomes (15)
Adverse Events (AE)
Safety parameters reported in the period from baseline to 28 days after the last dose of the study drug:
- Treatment-emergent AEs
- Treatment-emergent Serious Adverse Events (SAE)
- Treatment emergent Adverse Event of Special Interest (AESI)
- Treatment-emergent treatment-related AEs
- Treatment-emergent treatment-related SAEs
- Treatment emergent related AESIs
- AEs leading to early discontinuation of study treatment
- Treatment-emergent deaths
- Cause of death
- Treatment-emergent changes in clinical laboratory findings
- Vital signs
Measured: 56 weeks corresponding to 28 days after the last dose of study drug
Treatment efficacy measured by the absolute change in percent predicted forced vital capacity (%FVC)
Treatment efficacy at Week 24 measured by the absolute change from baseline to Week 24 in percent predicted forced vital capacity (%FVC) :
- Patients with progressive disease will be defined as absolute decline of 10% or more in %FVC. Missing values or death will be also considered as progressive.
- Patients with non-progressive disease will be defined as improvement or no decline in %FVC or a decline of %FVC<10%.
Measured: 24 weeks
Relative change in in percent predicted forced vital capacity
Relative change from baseline to Week 52 in percent predicted forced vital capacity (%FVC)
Measured: 52 weeks
Absolute change in in percent predicted forced vital capacity
Relative and absolute change from baseline to Week 52 in percent predicted forced vital capacity (%FVC)
Measured: 52 weeks
Relative change in in percent predicted forced vital capacity
Relative and absolute change from baseline to Week 24 in percent predicted forced vital capacity (%FVC)
Measured: 24 weeks
Absolute change in in percent predicted forced vital capacity
Relative and absolute change from baseline to Week 24 in percent predicted forced vital capacity (%FVC)
Measured: 24 weeks
Six minute walk test (6MWT) distance
Change from Baseline to Week 52 in the six minute walk test (6MWT) distance
Measured: 52 weeks
Six minute walk test (6MWT) distance
Change from Baseline to Week 24 in the six minute walk test (6MWT) distance
Measured: 24 weeks
Carbon Monoxide Diffusing Capacity (%DLCO)
Change from Baseline to Week 52 in the percent predicted Carbon Monoxide Diffusing Capacity (%DLCO)
Measured: 52 weeks
Carbon Monoxide Diffusing Capacity (%DLCO)
Change from Baseline to Week 24 in the percent predicted Carbon Monoxide Diffusing Capacity (%DLCO)
Measured: 24 weeks
Progression-free survival
Progression-free survival defined as the time to the first occurrence of any one of the following: a confirmed decrease of 10 percentage points or more in %FVC, a confirmed decrease of 15 percentage points or more in %DLCO, or death.
Measured: 52 weeks
Dyspnea
Change from Baseline to Week 52 in dyspnea as measured by the New York Heart Association classification, the modified Borg scale and by the Saint-George's Respiratory Questionnaire (SGRQ).
Measured: 52 weeks
Chest CT-scan
Change in Chest-CT scan abnormalities at Week 52 (evaluated after a centralized blinded review of the chest CT-scans).
Measured: 52 weeks
Quality of Life assessed by the Health Assessment Questionnaire (HAQ)
Measured: 52 weeks
Quality of Life assessed by the Short Form-36 (SF-36)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start31 Jan 2018
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jonathan London, MD, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385668
- Sponsor's protocol ID
- P161001J
- Other IDs
- 2017-002782-22, 2017
- Acronym
- PIRFENIVAS
- Status last verified
- Oct 2025
- First submitted
- 7 Dec 2017
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hervier B, Pagnoux C, Agard C, Haroche J, Amoura Z, Guillevin L, Hamidou MA; French Vasculitis Study Group. Pulmonary fibrosis associated with ANCA-positive vasculitides. Retrospective study of 12 cases and review of the literature. Ann Rheum Dis. 2009 Mar;68(3):404-7. doi: 10.1136/ard.2008.096131. Epub 2008 Oct 28.
PubMed 18957485King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18.
PubMed 24836312Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.
PubMed 26835133
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Pulmonary Fibrosis With Anti-myeloperoxydase (MPO) Antibodies or With Anti-MPO Associated Vasculitis."
- ClinicalTrials.gov ID
- NCT03385668
- Acronym / sponsor ID
- PIRFENIVAS / P161001J
- Conditions
- Pulmonary Fibrosis
- Keywords
- Pulmonary fibrosis, Antibodies, Antineutrophil Cytoplasmic, Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis, Pirfenidone, Microscopic Polyangiitis, Interstitial lung disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Roche Pharma AG, URC-CIC Paris Descartes Necker Cochin
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 28 Dec 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.
The purpose of this study is to determine wether pirfenidone is safe and effective in the treatment of pulmonary fibrosis with anti-myeloperoxydase (MPO) antibodies or pulmonary fibrosis with anti-MPO associated vasculitis.
Detailed description
Pulmonary fibrosis can be associated with Anti-Neutrophil Cytoplasmic Antibody (ANCA) directed against MPO or with anti-MPO associated vasculitis, leading to increased disability and poor prognosis. The pathophysiology of this association remains unclear. Conventional therapies used for the treatment of vasculitis manifestations are often disappointing for the treatment of pulmonary fibrosis. The main cause of death in patients with anti-MPO ANCA associated vasculitis and associated pulmonary fibrosis is the progression of pulmonary fibrosis. No treatment has demonstrated efficacy to stabilize or improve pulmonary fibrosis associated with anti-MPO associated vasculitis.
Previous studies showed that Pirfenidone improves survival and pulmonary function in patients with idiopathic pulmonary fibrosis (IPF) and that Pirfenidone treatment is safe and well tolerated in IPF. Patients with anti-MPO associated vasculitis (or anti-MPO antibodies without vasculitis) and associated pulmonary fibrosis might benefit from the use of Pirfenidone. However, the efficacy and safety of pirfenidone in patients with anti-MPO associated vasculitis and associated pulmonary fibrosis has not been evaluated. This study was designed to assess the efficacy and safety of pirfenidone in patients with pulmonary fibrosis and anti-MPO ANCA associated vasculitis or anti-MPO antibodies without vasculitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone | Experimental | Drug: PirfenidoneAll patients will receive Pirfenidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Presence of anti-MPO antibody (ELISA) at inclusion or during pulmonary fibrosis follow-up and/or diagnosis of anti-MPO associated vasculitis according to the 2012 Revised International Chapel Hill Consensus Conference definitions
- Definite or possible Usual Interstitial Pneumonia or Non Specific Interstitial Pneumonia based on high-resolution computed tomography
- Presence of pulmonary fibrosis, defined as a range of 50 to 90% of the %FVC and a range of 30 to 90% of the %DLCO
- Pulmonary fibrosis refractory (according to the investigator's judgment) to a conventional regimen used for anti-MPO associated vasculitis when a treatment against vasculitis has been used
Key exclusion criteria (15 listed)
- Other type of systemic vasculitis;
- Active vasculitis defined by Birmingham Vasculitis Activity Score >3 (BVAS) ;
- Contraindication to Pirfenidone;
- Unable to perform pulmonary function test (PFT);
- Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study : implants of levonorgestrel; injectable progesterone; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progesterone only); double barrier method (condom, cervical cap or diaphragm with spermicidal agent); transdermal contraceptive patch; male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject;
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 |
|---|---|---|
| PirfenidonePirfenidone at a dose of 2403 mg/day for 50 weeks, after a 2 weeks period of titration (801 mg/day for one week then 1602 mg/day for one week). | Drug | Pirfenidone |
Primary outcome
Treatment efficacy measured by the absolute change in percent predicted forced vital capacity (%FVC)
Time frame: 52 weeks
Treatment efficacy at Week 52 measured by the absolute change from baseline to Week 52 in percent predicted forced vital capacity (%FVC) : * Patients with progressive disease will be defined as absolute decline of 10% or more in %FVC. Missing values or death will be also considered as progressive. * Patients with non-progressive disease will be defined as improvement or no decline in %FVC or a decline of %FVC<10%.
15 secondary outcomes
Adverse Events (AE)
Time frame: 56 weeks corresponding to 28 days after the last dose of study drug
Treatment efficacy measured by the absolute change in percent predicted forced vital capacity (%FVC)
Time frame: 24 weeks
Relative change in in percent predicted forced vital capacity
Time frame: 52 weeks
Absolute change in in percent predicted forced vital capacity
Time frame: 52 weeks
Relative change in in percent predicted forced vital capacity
Time frame: 24 weeks
Absolute change in in percent predicted forced vital capacity
Time frame: 24 weeks
Six minute walk test (6MWT) distance
Time frame: 52 weeks
Six minute walk test (6MWT) distance
Time frame: 24 weeks
Carbon Monoxide Diffusing Capacity (%DLCO)
Time frame: 52 weeks
Carbon Monoxide Diffusing Capacity (%DLCO)
Time frame: 24 weeks
Progression-free survival
Time frame: 52 weeks
Dyspnea
Time frame: 52 weeks
Chest CT-scan
Time frame: 52 weeks
Quality of Life assessed by the Health Assessment Questionnaire (HAQ)
Time frame: 52 weeks
Quality of Life assessed by the Short Form-36 (SF-36)
Time frame: 52 weeks
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 20 Nov 2025.
- Background: PubMed 18957485Hervier B, Pagnoux C, Agard C, Haroche J, Amoura Z, Guillevin L, Hamidou MA; French Vasculitis Study Group. Pulmonary fibrosis associated with ANCA-positive vasculitides. Retrospective study of 12 cases and review of the literature. Ann Rheum Dis. 2009 Mar;68(3):404-7. doi: 10.1136/ard.2008.096131. Epub 2008 Oct 28.
- Background: PubMed 24836312King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18.
- Background: PubMed 26835133Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.
- 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.
Jonathan London, MD principal investigator
Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone in people with Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 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 20 Nov 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Treatment efficacy measured by the absolute change in percent predicted forced vital capacity (%FVC) (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 NCT03385668, which also lists 3 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 20 Nov 2025.