TuberculosisNCT06246851
BCG Revaccination Study in Diabetic and Non-Diabetic Adults
A study testing BCG Danish in people with Tuberculosis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to: 1. explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- BCG Danish
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2024to 31 Aug 2028
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18-65 years
- Resident in or near Oxford for the duration of the study period
- Provide written informed consent
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner (or review summary care record, if available)
- Allow the investigator to register volunteer details with a confidential database (The Over- volunteering Protection Service) to prevent concurrent entry into clinical studies/trials
- Agreement to refrain from blood donation during the course of the study
Show all 13Show fewer
- For persons of child-bearing potential (POCBP) only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening, vaccination and bronchoscopy
- Able and willing (in the investigator's opinion) to comply with all study requirements
- No clinically relevant findings on physical examination
- Screening IGRA negative
- Willing to be tested for evidence of SARS-CoV-2 infection and to allow public health notification of the results if required
- Previously vaccinated with the BCG (at least 12 months prior to enrolment, as evidenced by a visible scar or documentation in medical or occupational health records)
- Group C only - Documented diagnosis of T2DM (made at least 12 months prior to enrolment) initiated on a management plan with medication including use of metformin
Who cannot join
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period
- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study agent, any essential study procedure, sedative drugs, or any local or general anaesthetic agents
- Clinically significant history of skin disorder, allergy, atopy, cancer (except BCC of the skin or CIS of the cervix), bleeding disorder, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder (excluding T2DM in Group C only), neurological illness, psychiatric disorder, drug or alcohol abuse
- Any significant autoimmune conditions or immunodeficiency (including HIV)
- Previous diagnosis or treatment for TB disease or latent TB infections
- Clinical, radiological, or laboratory evidence of current active TB disease or latent TB infection
Show all 27Show fewer
- Previous receipt of any investigational TB vaccine or aerosolised BCG
- More than one previous BCG vaccination
- Positive HBsAg, HCV or HIV antibodies
- Concurrent use of oral, inhaled or systemic steroid medication or use for more than 14 days within the last 6 months (steroids used as a cream or ointment are permissible), or the use of other immunosuppressive agents concurrently or for more than 14 days within the last 6 months
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned study vaccination date
- Administration of a live vaccine within the preceding 28 days prior to enrolment
- Administration of any other non-live vaccine within the preceding 14 days prior to enrolment
- Pregnancy, lactation or intention to become pregnant during study period
- Previously resident for more than 12 months concurrently in the rural areas of a tropical climate where significant non-tuberculous mycobacterial exposure is likely
- Any other clinically significant abnormality of screening blood or urine tests
- Any other significant disease, disorder, or finding, which, in the opinion of the investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the study or impair interpretation of the study data
- A body mass index (BMI) of <18.5 or >45
- Group A or B Specific Exclusions:
- Any clinically significant respiratory disease, including asthma
- Current smoker (defined as any smoking including e-cigarettes in the last 3 months)
- Current use of any medication or other drug taken through the nasal or inhaled route including cocaine or other recreational drugs
- Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
- Shares a household with someone with clinically significant immunodeficiency (either from infection or medication) who is deemed to be at risk of developing disseminated BCG infection if exposed to BCG
- An HBA1c at screening of > 48mmol/Lmol
- Clinically significant abnormality on screening chest radiograph
- Clinically significant abnormality of lung function testing
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Clinical Study Comparing the Immune Response to Revaccination With Intradermal BCG and Aerosol BCG in Previously BCG Vaccinated Healthy Adult Volunteers With and Without Type 2 Diabetes
The purpose of this study is to:
- explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection.
- explore if there are differences in response to re-vaccination in healthy volunteers with and without Type 2 Diabetes.
It will involve 36 previously BCG-vaccinated participants. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.
Read the detailed description
Worldwide Tuberculosis (TB) remains the leading cause of death from an infectious disease. Key research priorities include the development of effective vaccine strategies.
Currently, the only licensed vaccine against TB is BCG (Bacille Calmette-Guérin) injected under the skin (intradermal). This works well as a single dose vaccination against TB in childhood but is often ineffective in adults. Previous studies have investigated the benefit of booster doses of intradermal BCG; although these have not shown a clear benefit in reducing the risk of getting a TB infection there is emerging evidence that it may reduce its duration. Certain groups of people are at a higher risk of infection with Mycobacterium tuberculosis, the bacterium that causes TB. An important risk group are those with Diabetes Mellitus, who are at an increased risk of both becoming infected and dying from the disease. The reason for this is not clear, however differences in the immune response to Mycobacteria are thought to be important. Strategies to improve protection of high risk groups including those with Diabetes are needed to reduce the global burden of TB.
Localised immune responses can differ to those seen systemically. Vaccine studies in other infectious diseases have shown that altering the route of administration can improve protection from disease. There is also evidence from animal studies that breathing in BCG as a fine mist (aerosol) can make the vaccine more effective than BCG injections. Previous clinical trials in our group (TB041 and TB044) and a current study (TB043) recruited healthy volunteers and showed that aerosol inhaled BCG can be safely administered. It has also been shown that BCG given this way can elicit immunological responses not seen in the systemic blood compartment. Vaccination with BCG through the respiratory tract therefore offers an important alternative to intradermal vaccination, which has the potential to be a more effective route for a boosting vaccine.
This study will provide data on the immune response to booster vaccination with BCG. The investigators will compare how these responses differ between routes of vaccine delivery (aerosol inhaled BCG versus intradermal vaccination), and also explore how the immune response to revaccination differs in adults with Type 2 diabetes (T2DM). The investigators will use the findings to explore the potential benefits of aerosol vaccination and to investigate differences in the immune responses in diabetic individuals to understand how the investigators can improve protection against TB in this high risk group.
It will involve a total of 36 previously BCG-vaccinated participants; 12 healthy volunteers will receive boosting vaccination with aerosol BCG, while a further 12 healthy volunteers will receive a boosting vaccination with intradermal BCG. The investigators will perform washings from the lungs (bronchoscopies) 14 days after BCG vaccination to measure immunological and bacterial responses. A further 12 previously BCG-vaccinated, healthy adult volunteers with T2DM will receive a boosting vaccination with intradermal BCG. The investigators will take blood samples from all volunteers to explore the immune response to BCG and to develop markers to understand who has developed a protective immune response to TB.
- Conditions
- Tuberculosis
- Being tested
- BCG Danish
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG DanishBiological
BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
| Study group | Role | What they receive |
|---|---|---|
| Group A: A1: 2-8 x 10^5 cfu or 1 x 10^5 cfu intradermal BCG (non-type 2 diabetic group) | Experimental | A1: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 2-8 X 10^5 cfu intradermally injected BCG.
A2: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 1 x 10^5 cfu intradermally injected BCG.
All Group A volunteers will have a bronchoscopy 14 days post challenge. Receives: Biological: BCG Danish |
| Group B: 2-8 x 10^6 cfu or 1 x 10^6 cfu aerosol inhaled BCG (non-type 2 diabetic group) | Experimental | B1: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 2-8 X 10^6 cfu aerosol inhaled BCG.
B2: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 1 X 10^6 cfu aerosol inhaled BCG.
All Group B volunteers will have a bronchoscopy 14 days post challenge. Receives: Biological: BCG Danish |
| Group C: 2-8 x 10^5 cfu or 1 x 10^5 cfu intradermal BCG (type 2 diabetic group) | Experimental | C1: 6 historically BCG-vaccinated volunteers with confirmed type 2 diabetes will receive 2-8 X 10^5 cfu intradermally injected BCG.
C2: 6 historically BCG-vaccinated volunteers with confirmed type 2 diabetes will receive 1 X 10^5 cfu intradermally injected BCG.
All Group C volunteers will not have a bronchoscopy. Receives: Biological: BCG Danish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradermal vs. aerosol BCG in non-type 2 diabetics
To compare the immunological response of BCG re-vaccination by the aerosol inhaled route to the intradermal route in healthy historically intradermally BCG-vaccinated volunteers.
This will be measured using laboratory markers of innate and adaptive immunity, which may include ex-vivo ELISpot and ELISAs, RNA sequence analysis and intracellular cytokine staining of blood. This will also be measured using flow cytometry, ELISA and cytokine staining of BAL samples.
This will be achieved by blood test done at each follow up visit and bronchoscopy to retrieve BAL sample at Day 14 visit for non- diabetic volunteers.
Measured: Up to day 168
Intradermal (in type 2 diabetics) vs intradermal (in non-type 2 diabetics)
To compare the immunological response of BCG re-vaccination by the intradermal route in historically intradermally BCG-vaccinated volunteers with Type 2 Diabetes and non-diabetic healthy adults.
This will be measured using laboratory markers of innate and adaptive immunity, which may include ex-vivo ELISPOT and ELISAs, RNA sequence analysis and intracellular cytokine staining of blood.
This will be achieved through the blood test done at each follow up visit.
Measured: Up to day 168
Secondary outcomes (1)
Intradermal or aerosol BCG re-vaccination safety in healthy volunteers
To describe the safety of intradermal or aerosol BCG as a BCG re-vaccination in healthy UK Volunteers.
This will be measured using actively and passively collected data on adverse events and detailed participant symptom profiles throughout the study duration.
Measured: Up to day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start3 Apr 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 1 study exploring differences between the immunological responses to revaccination with intradermal-BCG and aerosol-inhaled BCG in healthy adults and those with pre-existing T2DM. There will be three study groups with twelve volunteers in each group. Volunteers will be enrolled into groups based upon whether they have a diagnosis of T2DM. They will then be vaccinated with intradermal BCG (Groups A and C) or aerosolised BCG (Group B).
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen McShane, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246851
- Sponsor's protocol ID
- TB046
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing the Immune Response to Revaccination With Intradermal BCG and Aerosol BCG in Previously BCG Vaccinated Healthy Adult Volunteers With and Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06246851
- Acronym / sponsor ID
- TB046
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Feb 2024 (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:
- explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection.
- explore if there are differences in response to re-vaccination in healthy volunteers with and without Type 2 Diabetes.
It will involve 36 previously BCG-vaccinated participants. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.
Detailed description
Worldwide Tuberculosis (TB) remains the leading cause of death from an infectious disease. Key research priorities include the development of effective vaccine strategies.
Currently, the only licensed vaccine against TB is BCG (Bacille Calmette-Guérin) injected under the skin (intradermal). This works well as a single dose vaccination against TB in childhood but is often ineffective in adults. Previous studies have investigated the benefit of booster doses of intradermal BCG; although these have not shown a clear benefit in reducing the risk of getting a TB infection there is emerging evidence that it may reduce its duration. Certain groups of people are at a higher risk of infection with Mycobacterium tuberculosis, the bacterium that causes TB. An important risk group are those with Diabetes Mellitus, who are at an increased risk of both becoming infected and dying from the disease. The reason for this is not clear, however differences in the immune response to Mycobacteria are thought to be important. Strategies to improve protection of high risk groups including those with Diabetes are needed to reduce the global burden of TB.
Localised immune responses can differ to those seen systemically. Vaccine studies in other infectious diseases have shown that altering the route of administration can improve protection from disease. There is also evidence from animal studies that breathing in BCG as a fine mist (aerosol) can make the vaccine more effective than BCG injections. Previous clinical trials in our group (TB041 and TB044) and a current study (TB043) recruited healthy volunteers and showed that aerosol inhaled BCG can be safely administered. It has also been shown that BCG given this way can elicit immunological responses not seen in the systemic blood compartment. Vaccination with BCG through the respiratory tract therefore offers an important alternative to intradermal vaccination, which has the potential to be a more effective route for a boosting vaccine.
This study will provide data on the immune response to booster vaccination with BCG. The investigators will compare how these responses differ between routes of vaccine delivery (aerosol inhaled BCG versus intradermal vaccination), and also explore how the immune response to revaccination differs in adults with Type 2 diabetes (T2DM). The investigators will use the findings to explore the potential benefits of aerosol vaccination and to investigate differences in the immune responses in diabetic individuals to understand how the investigators can improve protection against TB in this high risk group.
It will involve a total of 36 previously BCG-vaccinated participants; 12 healthy volunteers will receive boosting vaccination with aerosol BCG, while a further 12 healthy volunteers will receive a boosting vaccination with intradermal BCG. The investigators will perform washings from the lungs (bronchoscopies) 14 days after BCG vaccination to measure immunological and bacterial responses. A further 12 previously BCG-vaccinated, healthy adult volunteers with T2DM will receive a boosting vaccination with intradermal BCG. The investigators will take blood samples from all volunteers to explore the immune response to BCG and to develop markers to understand who has developed a protective immune response to TB.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a phase 1 study exploring differences between the immunological responses to revaccination with intradermal-BCG and aerosol-inhaled BCG in healthy adults and those with pre-existing T2DM. There will be three study groups with twelve volunteers in each group. Volunteers will be enrolled into groups based upon whether they have a diagnosis of T2DM. They will then be vaccinated with intradermal BCG (Groups A and C) or aerosolised BCG (Group B).
| Arm | Type | Receives |
|---|---|---|
| Group A: A1: 2-8 x 10^5 cfu or 1 x 10^5 cfu intradermal BCG (non-type 2 diabetic group) | Experimental | Biological: BCG DanishA1: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 2-8 X 10^5 cfu intradermally injected BCG. A2: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 1 x 10^5 cfu intradermally injected BCG. All Group A volunteers will have a bronchoscopy 14 days post challenge. |
| Group B: 2-8 x 10^6 cfu or 1 x 10^6 cfu aerosol inhaled BCG (non-type 2 diabetic group) | Experimental | Biological: BCG DanishB1: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 2-8 X 10^6 cfu aerosol inhaled BCG. B2: 6 historically BCG-vaccinated volunteers without type 2 diabetes will receive 1 X 10^6 cfu aerosol inhaled BCG. All Group B volunteers will have a bronchoscopy 14 days post challenge. |
| Group C: 2-8 x 10^5 cfu or 1 x 10^5 cfu intradermal BCG (type 2 diabetic group) | Experimental | Biological: BCG DanishC1: 6 historically BCG-vaccinated volunteers with confirmed type 2 diabetes will receive 2-8 X 10^5 cfu intradermally injected BCG. C2: 6 historically BCG-vaccinated volunteers with confirmed type 2 diabetes will receive 1 X 10^5 cfu intradermally injected BCG. All Group C volunteers will not have a bronchoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy adults aged 18-65 years
- Resident in or near Oxford for the duration of the study period
- Provide written informed consent
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner (or review summary care record, if available)
- Allow the investigator to register volunteer details with a confidential database (The Over- volunteering Protection Service) to prevent concurrent entry into clinical studies/trials
Key exclusion criteria (27 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period
- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study agent, any essential study procedure, sedative drugs, or any local or general anaesthetic agents
- Clinically significant history of skin disorder, allergy, atopy, cancer (except BCC of the skin or CIS of the cervix), bleeding disorder, cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder (excluding T2DM in Group C only), neurological illness, psychiatric disorder, drug or alcohol abuse
- Any significant autoimmune conditions or immunodeficiency (including HIV)
- Previous diagnosis or treatment for TB disease or latent TB infections
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 |
|---|---|---|
| BCG DanishBCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route. | Biological | Group A: A1: 2-8 x 10^5 cfu or 1 x 10^5 cfu intradermal BCG (non-type 2 diabetic group), Group B: 2-8 x 10^6 cfu or 1 x 10^6 cfu aerosol inhaled BCG (non-type 2 diabetic group), Group C: 2-8 x 10^5 cfu or 1 x 10^5 cfu intradermal BCG (type 2 diabetic group) |
Primary outcome
Intradermal vs. aerosol BCG in non-type 2 diabetics
Time frame: Up to day 168
To compare the immunological response of BCG re-vaccination by the aerosol inhaled route to the intradermal route in healthy historically intradermally BCG-vaccinated volunteers. This will be measured using laboratory markers of innate and adaptive immunity, which may include ex-vivo ELISpot and ELISAs, RNA sequence analysis and intracellular cytokine staining of blood. This will also be measured using flow cytometry, ELISA and cytokine staining of BAL samples. This will be achieved by blood test done at each follow up visit and bronchoscopy to retrieve BAL sample at Day 14 visit for non- diabetic volunteers.
Intradermal (in type 2 diabetics) vs intradermal (in non-type 2 diabetics)
Time frame: Up to day 168
To compare the immunological response of BCG re-vaccination by the intradermal route in historically intradermally BCG-vaccinated volunteers with Type 2 Diabetes and non-diabetic healthy adults. This will be measured using laboratory markers of innate and adaptive immunity, which may include ex-vivo ELISPOT and ELISAs, RNA sequence analysis and intracellular cytokine staining of blood. This will be achieved through the blood test done at each follow up visit.
1 secondary outcome
Intradermal or aerosol BCG re-vaccination safety in healthy volunteers
Time frame: Up to day 168
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 24 Apr 2026.
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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.
Helen McShane, Professor principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCG Danish in people with Tuberculosis, run by University of Oxford at 1 site in United Kingdom.
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 13 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. 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 Kingdom. 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?
Intradermal vs. aerosol BCG in non-type 2 diabetics (time frame: Up to day 168). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.