Chronic Pulmonary AspergillosisPhase 3POSITRONNCT07825259
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
A Phase 3 study testing Posaconazole Delayed Release Oral Tablet and Itraconazole (ITZ) in people with Chronic Pulmonary Aspergillosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial summary
A prospective, randomized, open-label comparative study evaluating oral itraconazole and oral posaconazole in treatment-naïve patients with CPA, with treatment for 12 months is proposed. The study will compare clinical effectiveness and safety of the study drugs. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Chronic Pulmonary Aspergillosis
- What is being tested?
- Posaconazole Delayed Release Oral Tablet and Itraconazole (ITZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Phase 3
- 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 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- One or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, fever, dyspnoea) for ≥3 months
- Slowly progressive or persistent radiological findings on CT thorax including one or more cavities with or without a fungal ball, fibrosis, pericavitary infiltrates, consolidation, nodules, or pleural thickening
- Serum A. fumigatus-IgG ≥27 milligrams of antibody/litre (mgA/L), or growth of Aspergillus in respiratory secretions (twice in sputum or once in bronchoalveolar lavage fluid [BALF]) or serum galactomannan index (GMI) ≥1.7 or BALF GMI ≥2.6.
- Exclusion of other pulmonary disorders with similar presentation (active pulmonary TB, malignancy, other infections)
Who cannot join
- Failure or refusal to provide written informed consent
- Patients on immunosuppressive drugs, receiving prednisolone (or equivalent) ≥10 mg/day for ≥3 weeks, or known HIV infection
- Intake of antifungal triazoles for ≥3 weeks in the preceding 3 months (prior azole therapy)
- Active pulmonary infection due to Mycobacterium tuberculosis or non-tuberculous mycobacteria
- Other forms of pulmonary aspergillosis (subacute or acute invasive aspergillosis)
- Pregnancy or lactation
- Significant hepatic dysfunction (ALT/AST ≥3× upper limit of normal at baseline)
- Known hypersensitivity to azole antifungals
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites
Chest Clinic, PGIMER, Chandigarh
Chandigarh, Chandigarh, 160012
Inderpaul S Sehgal, DM, +91-172-2756823, inderpgi@outlook.com
Chest Clinic, PGIMER, Chandigarh
Chandigarh, Chandigarh, 160012
About this study
Official title: Optimizing Azole Therapy in Chronic Pulmonary Aspergillosis: A Randomized Comparative Study of Itraconazole and Posaconazole Integrating Clinical Outcomes, Azole Exposure, and Resistance Surveillance
A prospective, randomized, open-label comparative study evaluating oral itraconazole and oral posaconazole in treatment-naïve patients with CPA, with treatment for 12 months is proposed. The study will compare clinical effectiveness and safety of the study drugs.
The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease
Read the detailed description
Chronic pulmonary aspergillosis (CPA) is a progressive fungal lung disease associated with substantial morbidity and mortality. India bears one of the largest global burdens of CPA owing to the high prevalence of post-tuberculosis lung disease (PTLD), the principal predisposing condition for CPA in low- and middle-income countries (Expert Rev Anti Infect Ther 2026;1-21; Mycoses 2025;68:e70060). Despite increasing recognition of CPA as a major public health problem, several critical gaps remain in the optimization of antifungal therapy, particularly with respect to azole selection, pharmacokinetic variability, and the emergence of antifungal resistance during prolonged treatment.
Oral itraconazole remains the recommended first-line therapy for CPA (Expert Rev Anti Infect Ther 2026;1-21; Mycoses 2025;68:e70060; Lancet Infect Dis 2026;26:239-249; Curr Opin Pulm Med 2024;30:156-166; Lancet Infect Dis 2022;22:1052-1061). Our group, in a randomized controlled trial, previously showed that extending itraconazole therapy from 6 to 12 months significantly improves treatment outcomes (Lancet Infect Dis 2022;22:1052-1061). However, itraconazole exhibits considerable inter-individual variability in systemic drug exposure, requires therapeutic drug monitoring, and may fail to achieve adequate systemic exposure in a subset of patients (J Antimicrob Chemother 2014;69:1162-1176). Furthermore, prolonged azole exposure may contribute to the development of antifungal resistance, an emerging challenge with important implications for long-term disease control (Expert Rev Anti Infect Ther 2026;1-21). More recently, we showed that voriconazole was not superior to itraconazole in treating CPA; moreover, it was associated with a higher incidence of adverse events (Lancet Infect Dis 2026;26:239-249).
Posaconazole is an attractive alternative to itraconazole and voriconazole owing to its favourable pharmacokinetic profile, predictable systemic exposure, improved tolerability, and potent activity against Aspergillus species. However, its role as primary therapy for CPA has not been evaluated in a randomized clinical trial (Expert Rev Anti Infect Ther 2026;1-21). In addition, prospective data on the emergence of azole resistance during prolonged therapy and its relationship with treatment outcomes remain limited.
This prospective, randomized, open-label comparative study will evaluate oral itraconazole and oral posaconazole in 220 treatment-naïve patients with CPA, with treatment for 12 months. The study will compare clinical effectiveness and safety of the study drugs.
By integrating clinical, microbiological, and azole exposure data, the proposed study seeks to identify determinants of treatment success and failure, define exposure-response relationships for azole therapy, and characterize the emergence of resistance during prolonged treatment. The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease
- Conditions
- Chronic Pulmonary Aspergillosis
- Being tested
- Posaconazole Delayed Release Oral Tablet, Itraconazole (ITZ)
- Keywords
- Aspergillosis, Triazoles, Posaconazole, Itraconazole, Aspergilloma
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posaconazole Delayed Release Oral TabletDrug
Posaconazole 300 mg will be given once daily
Itraconazole (ITZ)Drug
Itraconazole suprabioavailable will be given 130 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole | Active comparator | Itraconazole suprabioavailable capsule 130 mg twice daily Receives: Drug: Itraconazole (ITZ) |
| Posaconazole | Experimental | Posaconazole 100 mg sustained release capsule (300 mg once a day) Receives: Drug: Posaconazole Delayed Release Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall favorable treatment response at 12 months
Defined by: (1) Clinical improvement or stability; (2) Radiological improvement or stability on chest CT; and (3) No requirement for antifungal modification because of treatment failure.
Measured: 12 months
Secondary outcomes (5)
Significant treatment-emergent adverse events
Adverse events requiring discontinuation of study medication
Measured: 12 months
CPA relapse
Relapse after treatment cessation (assessed at 18 months from randomization)
Measured: 18 months
Time to first CPA relapse
Time to CPA relapse by survival curve analysis
Measured: 18 months
Quality of life assessment by SGRQ
Change in St. George's Respiratory Questionnaire (SGRQ) score at 6 and 12 months
Measured: 12 months
All-cause and CPA-related mortality during follow-up
Any death during study
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pulmonary AspergillosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825259
- Sponsor's protocol ID
- IEC-08/2026-3813
- Acronym
- POSITRON
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared on reasonable request to the PI after all administrative clearances
Publications
REFERENCES Sehgal, I. S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2026). Post-tuberculosis lung disease and pulmonary aspergillosis management: challenges and considerations. Expert Rev Anti Infect Ther, 1-21. doi:10.1080/14787210.2026.2631525 Sehgal, I. S., Soundappan, K., Agarwal, R., Muthu, V., Dhooria, S., Prasad, K. T., . . . Chakrabarti, A. (2025). Prevalence of Chronic Pulmonary Aspergillosis in Patients With Mycobacterial and Non-Mycobacterial Tuberculosis Infection of the Lung: A Systematic Review and Meta-Analysis. Mycoses, 68(4), e70060. doi:10.1111/myc.70060 Sehgal, I. S., Agarwal, R., Dhooria, S., Prasad, K. T., Muthu, V., Aggarwal, A. N., . . . Chakrabarti, A. (2026). Oral itraconazole versus oral voriconazole for treatment-naive patients with chronic pulmonary aspergillosis in India (VICTOR-CPA trial): a single-centre, open-label, randomised, controlled, superiority trial. Lancet Infect Dis, 26(3), 239-249. doi:10.1016/S1473-3099(25)00537-7 Sehgal, I. S., Dhooria, S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2024). Burden, clinical features, and outcomes of post-tuberculosis chronic obstructive lung diseases. Curr Opin Pulm Med, 30(2), 156-166. doi:10.1097/MCP.0000000000001026 Sehgal, I. S., Dhooria, S., Muthu, V., Prasad, K. T., Aggarwal, A. N., Chakrabarti, A., . . . Agarwal, R. (2022). Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India. Lancet Infect Dis, 22(7), 1052-1061. doi:10.1016/S1473-3099(22)00057-3 Ashbee, H. R., Barnes, R. A., Johnson, E. M., Richardson, M. D., Gorton, R., & Hope, W. W. (2014). Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother, 69(5), 1162-1176. doi:10.1093/jac/dkt508 Soundappan, K., Sehgal, I. S., Prabhakar, N., Rana, S., Raju, R., Dhooria, S., . . . Agarwal, R. (2024). Incidence and prevalence of ch
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Azole Therapy in Chronic Pulmonary Aspergillosis: A Randomized Comparative Study of Itraconazole and Posaconazole Integrating Clinical Outcomes, Azole Exposure, and Resistance Surveillance
- ClinicalTrials.gov ID
- NCT07825259
- Acronym / sponsor ID
- POSITRON / IEC-08/2026-3813
- Conditions
- Chronic Pulmonary Aspergillosis
- Keywords
- Aspergillosis, Triazoles, Posaconazole, Itraconazole, Aspergilloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Sep 2026 (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.
A prospective, randomized, open-label comparative study evaluating oral itraconazole and oral posaconazole in treatment-naïve patients with CPA, with treatment for 12 months is proposed. The study will compare clinical effectiveness and safety of the study drugs.
The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease
Detailed description
Chronic pulmonary aspergillosis (CPA) is a progressive fungal lung disease associated with substantial morbidity and mortality. India bears one of the largest global burdens of CPA owing to the high prevalence of post-tuberculosis lung disease (PTLD), the principal predisposing condition for CPA in low- and middle-income countries (Expert Rev Anti Infect Ther 2026;1-21; Mycoses 2025;68:e70060). Despite increasing recognition of CPA as a major public health problem, several critical gaps remain in the optimization of antifungal therapy, particularly with respect to azole selection, pharmacokinetic variability, and the emergence of antifungal resistance during prolonged treatment.
Oral itraconazole remains the recommended first-line therapy for CPA (Expert Rev Anti Infect Ther 2026;1-21; Mycoses 2025;68:e70060; Lancet Infect Dis 2026;26:239-249; Curr Opin Pulm Med 2024;30:156-166; Lancet Infect Dis 2022;22:1052-1061). Our group, in a randomized controlled trial, previously showed that extending itraconazole therapy from 6 to 12 months significantly improves treatment outcomes (Lancet Infect Dis 2022;22:1052-1061). However, itraconazole exhibits considerable inter-individual variability in systemic drug exposure, requires therapeutic drug monitoring, and may fail to achieve adequate systemic exposure in a subset of patients (J Antimicrob Chemother 2014;69:1162-1176). Furthermore, prolonged azole exposure may contribute to the development of antifungal resistance, an emerging challenge with important implications for long-term disease control (Expert Rev Anti Infect Ther 2026;1-21). More recently, we showed that voriconazole was not superior to itraconazole in treating CPA; moreover, it was associated with a higher incidence of adverse events (Lancet Infect Dis 2026;26:239-249).
Posaconazole is an attractive alternative to itraconazole and voriconazole owing to its favourable pharmacokinetic profile, predictable systemic exposure, improved tolerability, and potent activity against Aspergillus species. However, its role as primary therapy for CPA has not been evaluated in a randomized clinical trial (Expert Rev Anti Infect Ther 2026;1-21). In addition, prospective data on the emergence of azole resistance during prolonged therapy and its relationship with treatment outcomes remain limited.
This prospective, randomized, open-label comparative study will evaluate oral itraconazole and oral posaconazole in 220 treatment-naïve patients with CPA, with treatment for 12 months. The study will compare clinical effectiveness and safety of the study drugs.
By integrating clinical, microbiological, and azole exposure data, the proposed study seeks to identify determinants of treatment success and failure, define exposure-response relationships for azole therapy, and characterize the emergence of resistance during prolonged treatment. The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole | Active comparator | Drug: Itraconazole (ITZ)Itraconazole suprabioavailable capsule 130 mg twice daily |
| Posaconazole | Experimental | Drug: Posaconazole Delayed Release Oral TabletPosaconazole 100 mg sustained release capsule (300 mg once a day) |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- One or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, fever, dyspnoea) for ≥3 months
- Slowly progressive or persistent radiological findings on CT thorax including one or more cavities with or without a fungal ball, fibrosis, pericavitary infiltrates, consolidation, nodules, or pleural thickening
- Serum A. fumigatus-IgG ≥27 milligrams of antibody/litre (mgA/L), or growth of Aspergillus in respiratory secretions (twice in sputum or once in bronchoalveolar lavage fluid [BALF]) or serum galactomannan index (GMI) ≥1.7 or BALF GMI ≥2.6.
- Exclusion of other pulmonary disorders with similar presentation (active pulmonary TB, malignancy, other infections)
Key exclusion criteria (8 listed)
- Failure or refusal to provide written informed consent
- Patients on immunosuppressive drugs, receiving prednisolone (or equivalent) ≥10 mg/day for ≥3 weeks, or known HIV infection
- Intake of antifungal triazoles for ≥3 weeks in the preceding 3 months (prior azole therapy)
- Active pulmonary infection due to Mycobacterium tuberculosis or non-tuberculous mycobacteria
- Other forms of pulmonary aspergillosis (subacute or acute invasive aspergillosis)
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 |
|---|---|---|
| Posaconazole Delayed Release Oral TabletPosaconazole 300 mg will be given once daily | Drug | Posaconazole |
| Itraconazole (ITZ)Itraconazole suprabioavailable will be given 130 mg twice daily | Drug | Itraconazole |
Primary outcome
Overall favorable treatment response at 12 months
Time frame: 12 months
Defined by: (1) Clinical improvement or stability; (2) Radiological improvement or stability on chest CT; and (3) No requirement for antifungal modification because of treatment failure.
5 secondary outcomes
Significant treatment-emergent adverse events
Time frame: 12 months
CPA relapse
Time frame: 18 months
Time to first CPA relapse
Time frame: 18 months
Quality of life assessment by SGRQ
Time frame: 12 months
All-cause and CPA-related mortality during follow-up
Time frame: 18 months
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 1 Oct 2026.
- BackgroundREFERENCES Sehgal, I. S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2026). Post-tuberculosis lung disease and pulmonary aspergillosis management: challenges and considerations. Expert Rev Anti Infect Ther, 1-21. doi:10.1080/14787210.2026.2631525 Sehgal, I. S., Soundappan, K., Agarwal, R., Muthu, V., Dhooria, S., Prasad, K. T., . . . Chakrabarti, A. (2025). Prevalence of Chronic Pulmonary Aspergillosis in Patients With Mycobacterial and Non-Mycobacterial Tuberculosis Infection of the Lung: A Systematic Review and Meta-Analysis. Mycoses, 68(4), e70060. doi:10.1111/myc.70060 Sehgal, I. S., Agarwal, R., Dhooria, S., Prasad, K. T., Muthu, V., Aggarwal, A. N., . . . Chakrabarti, A. (2026). Oral itraconazole versus oral voriconazole for treatment-naive patients with chronic pulmonary aspergillosis in India (VICTOR-CPA trial): a single-centre, open-label, randomised, controlled, superiority trial. Lancet Infect Dis, 26(3), 239-249. doi:10.1016/S1473-3099(25)00537-7 Sehgal, I. S., Dhooria, S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2024). Burden, clinical features, and outcomes of post-tuberculosis chronic obstructive lung diseases. Curr Opin Pulm Med, 30(2), 156-166. doi:10.1097/MCP.0000000000001026 Sehgal, I. S., Dhooria, S., Muthu, V., Prasad, K. T., Aggarwal, A. N., Chakrabarti, A., . . . Agarwal, R. (2022). Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India. Lancet Infect Dis, 22(7), 1052-1061. doi:10.1016/S1473-3099(22)00057-3 Ashbee, H. R., Barnes, R. A., Johnson, E. M., Richardson, M. D., Gorton, R., & Hope, W. W. (2014). Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother, 69(5), 1162-1176. doi:10.1093/jac/dkt508 Soundappan, K., Sehgal, I. S., Prabhakar, N., Rana, S., Raju, R., Dhooria, S., . . . Agarwal, R. (2024). Incidence and prevalence of ch
- Individual participant dataSharing planned: Undecided. IPD will be shared on reasonable request to the PI after all administrative clearances
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Posaconazole Delayed Release Oral Tablet and Itraconazole (ITZ) in people with Chronic Pulmonary Aspergillosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Inderpaul S Sehgal, MD, DM (+91-172-2756823, inderpgi@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall favorable treatment response at 12 months (time frame: 12 months). 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 NCT07825259, which also lists 1 linked publication.
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 1 Oct 2026.