Non-muscular Invasive Bladder CancerPhase 1NCT06100653
BCG for Therapeutic Use Phase I Clinical Trial
A Phase 1 study testing BCG for therapeutic use in people with Non-muscular Invasive Bladder Cancer, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscular Invasive Bladder Cancer
- What is being tested?
- BCG for therapeutic use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 30 Apr 2025
- 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
- 1. Patients aged 18 years and over after transurethral resection of non-muscular invasive bladder cancer, both male and female.
- 2. Voluntarily participate in the trial, provide valid identification, fully informed and signed a written informed consent form.
- 3. Eastern Cooperative Oncology Group (ECOG) score: 0 ~ 2. 4. According to the Guidelines for the Diagnosis and Treatment of Bladder Cancer (2022 edition), patients with histologically confirmed non-muscular invasive bladder cancer (NMIBC) who are assessed to be medium or high risk and need BCG intravesical instillation therapy (Patients who need secondary electroresection can be included in the study after the second electroresection is completed and the pathological results are confirmed to be medium-or high-risk non-muscular invasive bladder cancer). Excluding carcinoma in situ.
- 5. Clinical laboratory tests meet the following characteristics:
- Blood routine: no hematopoietic growth factor or transfusion support was used within 14 days before enrollment, including absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5×109/L; Platelet ≥100000/mm3 or 100×109/L; Hemoglobin ≥9 g/dL.
- Liver function: total serum bilirubin ≤1.5× upper limit of normal (ULN), total serum bilirubin <3×ULN, aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN in subjects with Gilbert syndrome.
- Renal function: creatinine clearance ≥45 mL/min (estimated according to Cockcroft Gault formula) or serum creatinine ≤1.5×ULN.
- Coagulation function: activated partial thromboplastin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.
Who cannot join
- 1. Any of the following:
- Those who have immunodeficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy that are likely to cause systemic BCG disease reaction.
- Allergic to BCG vaccine and its excipients.
- Patients with a history of severe adverse reactions to BCG vaccine such as BCG septicemia or systemic infection.
- Patients with acute or chronic active hepatitis B [Hepatitis B Surface Antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (DNA) copy number ≥103/mL], hepatitis C virus (HCV) antibody positive (HCV copy number ≥103/mL), human immunodeficiency virus (HIV) antibody positive, syphilis specific antibody positive, C-TST test strongly positive, active tuberculosis, patients who are receiving anti-tuberculosis treatment, and other patients with fever or acute infectious diseases.
- Patients with a history of serious diseases of cardiovascular, cerebrovascular, lung, liver, kidney and other important organs, or those with severe hypertension or diabetes that can not be controlled clinically judged by the investigators; Patients with symptomatic urinary tract infections.
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- New York Heart Association (NYHA) heart function grade ≥3. 2. Patients with tumors of other genitourinary system or other organs. 3. Patients with carcinoma in situ (Tis stage) or muscular invasive bladder urothelial carcinoma (T2 stage and above).
- 4. Received any BCG treatment for NMIBC within 2 years before enrollment. Or recurrence of NMIBC after BCG treatment at any time.
- 5. Patients who had received chemotherapy, radiotherapy or immunotherapy within 4 weeks before admission (except for immediate postoperative intravesical chemotherapy).
- 6. Pregnant or lactating women (currently breastfeeding or less than one year after delivery although there is no artificial breastfeeding), women of childbearing age who cannot guarantee effective contraception during the trial period, and plan to have a pregnancy plan within 6 months after the last dosing (Including the partner of the male subject).
- 7. It is known or suspected that bladder perforation or abnormal conditions such as prolonged operation time and massive bleeding occur during the operation.
- 8. The investigator judged that there was severe gross hematuria before enrollment, and suspected that the surgical wound had not healed or the urinary tract mucosa was damaged.
- 9. with cystitis or having received other intravesical drug therapy and severe bladder irritation,which was judged by the investigator to be expected to affect the evaluation of this study.
- 10. Complete bladder incontinence, defined as the use of more than 6 pads within 24 hours.
- 11. Participated in clinical trials of other drugs within 3 months before enrollment.
- 12. Regular drinkers within six months before enrollment, such as those who drink more than 14 units of alcohol per week (1 unit =360 mL beer with 5% alcohol, or 45 mL spirits with 40% alcohol, or 150 mL wine with 12% alcohol); Or have a history of drug abuse or drug use.
- 13. The investigator believes that there may be any conditions that increase the risk of the subjects or interfere with the execution of the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG for Therapeutic Use in Preventing Postoperative Recurrence of Non-muscular Invasive Bladder Cancer in People Aged 18 and Over
This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. in patients aged 18 and over after transethral resection of non-muscular invasive bladder cancer.
Read the detailed description
This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. in patients aged 18 and over after transethral resection of non-muscular invasive bladder cancer.
This study includes three stages: screening period, observation period of administration, and safety follow-up period.
Screening period:
within 28 days before the first administration, the subjects will be eligible for enrollment confirmation.
Observation period of administration:
10 patients with non-muscular invasive bladder cancer ≥ 14 days after operation were included.The 10 patients were infused with BCG 120mg once a week for 6 times, then once every 2 weeks for 3 times, and then once a month (30 days) for 10 times, with a total of 19 times.
The peripheral blood samples of the subjects were collected to evaluate the exposure and immune response characteristics of the drugs in the blood, and the urine samples were collected to examine the immune response characteristics and shedding of the drugs. The safety data of each subject were observed ,collected and recorded, including vital signs, laboratory examination, adverse event (AE) and serious adverse event (SAE) (within 7 days after the first 5 times of each infusion treatment, and within 14 days after the sixth infusion (before V8 visit)). After 14 days of follow-up after the sixth infusion of the last subject, the clinical trial Data and Safety Monitoring Board (DSMB) will conduct an interim analysis to evaluate the safety and tolerability based on the obtained data. For the AE that did not recover within 14 days after the sixth infusion, the investigators should followe up until the AE was remission, or returned to the baseline, or the subject's condition was stable, or the subject lost follow-up / death.
When the subjects continued 13 times in the later period of bladder instillation therapy; blood routine examination was performed before the 10th, 13th, 16th and 19th instillation, and blood biochemical examination was performed before the 13th and 19th instillation. Cystoscopy and urine cytology were performed at the 3rd, 6th, 9th and 12th months after the first infusion. The subjects then continued their follow-up visits..
Safety follow-up period:
Safety follow-up was performed for7 days after the last administration. For the AE that did not recover 7 days after the last administration, the investigators should follow up to AE remission, or return to the baseline, or the subject's condition was stable, or the subject lost follow-up / death.
- Conditions
- Non-muscular Invasive Bladder Cancer
- Being tested
- BCG for therapeutic use
- Keywords
- Safety and Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG for therapeutic useDrug
The 10 patients were infused with BCG 120mg dissolved in 40 ~ 50 mL normal saline once a week for 6 times, then once every 2 weeks for 3 times, and then once a month (30 days) for 10 times, with a total of 19 times.
| Study group | Role | What they receive |
|---|---|---|
| BCG for therapeutic use clinical trial group | Experimental | Ten patients with non-muscular invasive bladder cancer ≥14 days after surgery were included. Receives: Drug: BCG for therapeutic use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BCG for therapeutic use by medical examination, laboratory examination and follow-up
- After each infusion of the first 6 times:
- Body temperature,
- Blood pressure,
- Pulse；
- Blood routine within 12 hours after each infusion of the first 6 times;
- Urine routine before each infusion for the first 6 times;
- On the 14th day after the 6th infusion (before administration of V8 visit):
- Physiacl examination,
- Vital signs,
- Laboratory examination,
- 12-lead ECG examination,
- Color ultrasound of urinary system,
- Imaging results ,
- All AE and SAE during 0-7 days after each infusion of the first 5 times;
- All AE and SAE within 14 days after the end of the 6th infusion ;
- During the 7th to 19th infusion of the experimental drug:
- AE,
- SAE ,
- Tumor recurrence ,
- Examination results of safety follow-up : including AE, SAE, physical examination, vital signs, clinical laboratory examination , 12-lead ECG examination, color ultrasound of urinary system, imaging examination and so on.
Measured: About 18 months through study completion, including observation period of administration and safety follow-up period
Secondary outcomes (3)
PK characteristics of BCG for therapeutic use by the level of Mycobacterium tuberculosis in the blood sample
The peripheral blood of the subjects was collected within 1h before the 1st and 6th administration and 2 h±30 min、24 h±2 h after the 1st and 6th administration to evaluate the exposure of BCG for therapeutic use in the blood.
The levels of Mycobacterium tuberculosis (nucleic acid positive/negative) in the blood sample after the 1st and 6th administration were detected.
Measured: 1h before the 1st and 6th administration and 2 h±30 min、24 h±2 h after the 1st and 6th administration
Immune response characteristics of BCG for therapeutic use by the level of cytokines in the blood and urine sample
Blood sample collection: Peripheral blood samples of subjects were collected within 1 h before the 1st and 6th administration, and 2 h±30 min and 24 h±2 h after the 1st and 6th administration.
Urine sample collection: last excreted urine of subjects were collected before the 1st and 6th administration, and excreted urine of subjects were collected 2 h±1 h, 4 h±1 h, 8 h±2 h, and 24 h±3 h after 1st and 6th BCG administration .
The levels of interleukin 2 (IL-2), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 12 (IL-12), interferon gamma (IFN- γ) and tumor necrosis factor (TNF) in blood and urine sample were detected.
Measured: before the 1st and 6th administration， 2 h±30 min and 24 h±2 h after the 1st and 6th administration， 2 h±1 h, 4 h±1 h, 8 h±2 h, and 24 h±3 h after 1st and 6th BCG administration .
Shedding of BCG for therapeutic use by the level of Mycobacterium tuberculosis in the urine sample
The urine excreted from the subjects were collected on the 1st and 3rd day after the 1st and 6th administration , in which the urine on the first day included 2 h ±1 h, 4 h ±1 h, 8 h ±2 h and 24 h ±3 h after BCG administration, and only once on the 3rd day to investigate the drug shedding.
The levels of Mycobacterium tuberculosis (nucleic acid positive/negative) in the urine sample after the 1st and 6th administration were detected.
Measured: 1st and 3rd day after the 1st and 6th administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start22 Nov 2023
- Primary completion1 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscular Invasive Bladder CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiang Sh Suan, Doctor, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100653
- Sponsor's protocol ID
- LKM-2023-BCG01
- Status last verified
- Mar 2025
- First submitted
- 13 Oct 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG for Therapeutic Use in Preventing Postoperative Recurrence of Non-muscular Invasive Bladder Cancer in People Aged 18 and Over
- ClinicalTrials.gov ID
- NCT06100653
- Acronym / sponsor ID
- LKM-2023-BCG01
- Conditions
- Non-muscular Invasive Bladder Cancer
- Keywords
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 25 Oct 2023 (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 clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. in patients aged 18 and over after transethral resection of non-muscular invasive bladder cancer.
Detailed description
This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. in patients aged 18 and over after transethral resection of non-muscular invasive bladder cancer.
This study includes three stages: screening period, observation period of administration, and safety follow-up period.
Screening period:
within 28 days before the first administration, the subjects will be eligible for enrollment confirmation.
Observation period of administration:
10 patients with non-muscular invasive bladder cancer ≥ 14 days after operation were included.The 10 patients were infused with BCG 120mg once a week for 6 times, then once every 2 weeks for 3 times, and then once a month (30 days) for 10 times, with a total of 19 times.
The peripheral blood samples of the subjects were collected to evaluate the exposure and immune response characteristics of the drugs in the blood, and the urine samples were collected to examine the immune response characteristics and shedding of the drugs. The safety data of each subject were observed ,collected and recorded, including vital signs, laboratory examination, adverse event (AE) and serious adverse event (SAE) (within 7 days after the first 5 times of each infusion treatment, and within 14 days after the sixth infusion (before V8 visit)). After 14 days of follow-up after the sixth infusion of the last subject, the clinical trial Data and Safety Monitoring Board (DSMB) will conduct an interim analysis to evaluate the safety and tolerability based on the obtained data. For the AE that did not recover within 14 days after the sixth infusion, the investigators should followe up until the AE was remission, or returned to the baseline, or the subject's condition was stable, or the subject lost follow-up / death.
When the subjects continued 13 times in the later period of bladder instillation therapy; blood routine examination was performed before the 10th, 13th, 16th and 19th instillation, and blood biochemical examination was performed before the 13th and 19th instillation. Cystoscopy and urine cytology were performed at the 3rd, 6th, 9th and 12th months after the first infusion. The subjects then continued their follow-up visits..
Safety follow-up period:
Safety follow-up was performed for7 days after the last administration. For the AE that did not recover 7 days after the last administration, the investigators should follow up to AE remission, or return to the baseline, or the subject's condition was stable, or the subject lost follow-up / death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCG for therapeutic use clinical trial group | Experimental | Drug: BCG for therapeutic useTen patients with non-muscular invasive bladder cancer ≥14 days after surgery were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Patients aged 18 years and over after transurethral resection of non-muscular invasive bladder cancer, both male and female.
- 2. Voluntarily participate in the trial, provide valid identification, fully informed and signed a written informed consent form.
- 3. Eastern Cooperative Oncology Group (ECOG) score: 0 ~ 2. 4. According to the Guidelines for the Diagnosis and Treatment of Bladder Cancer (2022 edition), patients with histologically confirmed non-muscular invasive bladder cancer (NMIBC) who are assessed to be medium or high risk and need BCG intravesical instillation therapy (Patients who need secondary electroresection can be included in the study after the second electroresection is completed and the pathological results are confirmed to be medium-or high-risk non-muscular invasive bladder cancer). Excluding carcinoma in situ.
- Blood routine: no hematopoietic growth factor or transfusion support was used within 14 days before enrollment, including absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5×109/L; Platelet ≥100000/mm3 or 100×109/L; Hemoglobin ≥9 g/dL.
- Liver function: total serum bilirubin ≤1.5× upper limit of normal (ULN), total serum bilirubin <3×ULN, aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN in subjects with Gilbert syndrome.
Key exclusion criteria (17 listed)
- Those who have immunodeficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy that are likely to cause systemic BCG disease reaction.
- Allergic to BCG vaccine and its excipients.
- Patients with a history of severe adverse reactions to BCG vaccine such as BCG septicemia or systemic infection.
- Patients with acute or chronic active hepatitis B [Hepatitis B Surface Antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (DNA) copy number ≥103/mL], hepatitis C virus (HCV) antibody positive (HCV copy number ≥103/mL), human immunodeficiency virus (HIV) antibody positive, syphilis specific antibody positive, C-TST test strongly positive, active tuberculosis, patients who are receiving anti-tuberculosis treatment, and other patients with fever or acute infectious diseases.
- Patients with a history of serious diseases of cardiovascular, cerebrovascular, lung, liver, kidney and other important organs, or those with severe hypertension or diabetes that can not be controlled clinically judged by the investigators; Patients with symptomatic urinary tract 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 for therapeutic useThe 10 patients were infused with BCG 120mg dissolved in 40 ~ 50 mL normal saline once a week for 6 times, then once every 2 weeks for 3 times, and then once a month (30 days) for 10 times, with a total of 19 times. | Drug | BCG for therapeutic use clinical trial group |
Primary outcome
Safety and tolerability of BCG for therapeutic use by medical examination, laboratory examination and follow-up
Time frame: About 18 months through study completion, including observation period of administration and safety follow-up period
1. After each infusion of the first 6 times: * Body temperature, * Blood pressure, * Pulse； 2. Blood routine within 12 hours after each infusion of the first 6 times; 3. Urine routine before each infusion for the first 6 times; 4. On the 14th day after the 6th infusion (before administration of V8 visit): * Physiacl examination, * Vital signs, * Laboratory examination, * 12-lead ECG examination, * Color ultrasound of urinary system, * Imaging results , 5. All AE and SAE during 0-7 days after each infusion of the first 5 times; 6. All AE and SAE within 14 days after the end of the 6th infusion ; 7. During the 7th to 19th infusion of the experimental drug: * AE, * SAE , * Tumor recurrence , 8. Examination results of safety follow-up : including AE, SAE, physical examination, vital signs, clinical laboratory examination , 12-lead ECG examination, color ultrasound of urinary system, imaging examination and so on.
3 secondary outcomes
PK characteristics of BCG for therapeutic use by the level of Mycobacterium tuberculosis in the blood sample
Time frame: 1h before the 1st and 6th administration and 2 h±30 min、24 h±2 h after the 1st and 6th administration
Immune response characteristics of BCG for therapeutic use by the level of cytokines in the blood and urine sample
Time frame: before the 1st and 6th administration， 2 h±30 min and 24 h±2 h after the 1st and 6th administration， 2 h±1 h, 4 h±1 h, 8 h±2 h, and 24 h±3 h after 1st and 6th BCG administration .
Shedding of BCG for therapeutic use by the level of Mycobacterium tuberculosis in the urine sample
Time frame: 1st and 3rd day after the 1st and 6th administration
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 31 May 2025.
- 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.
Jiang Sh Suan, Doctor principal investigator
Hunan Cancer Hospital
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 BCG for therapeutic use in people with Non-muscular Invasive Bladder Cancer, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
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 8 inclusion and 17 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 31 May 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 China. 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?
Safety and tolerability of BCG for therapeutic use by medical examination, laboratory examination and follow-up (time frame: About 18 months through study completion, including observation period of administration and safety follow-up period). 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 31 May 2025.