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Ischemic Cerebrovascular DiseaseNCT06474507

Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease (CBSinICVD)

A study testing Calculus bovis sativus (CBS) in people with Ischemic Cerebrovascular Disease and Acute Ischemic Stroke, run by Tongji Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The most common cause of death for Chinese patients is ischemic cerebrovascular diseases(ICVD), particularly cerebral infarction. It places a heavy burden on people, families, and society as a whole and poses considerable risks of death and disability. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Calculus bovis sativus (CBS)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
2 sitesChina
Study dates
8 Aug 2024to Dec 2029
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ICVD cohort:
  • Subjects are able to understand the purpose and risks of the study, provide informed consent, and authorize the use of confidential health information in accordance with national and local privacy regulations.
  • Both men and women are welcome, and the age at the time of providing informed consent is 18-80 years (inclusive).
  • All women of childbearing age and all men must use contraceptive measures during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.
  • Must be diagnosed with
  • ① Ischemic stroke, according to the "Diagnosis Points of Various Cerebrovascular Diseases" of the Fourth National Cerebrovascular Disease Academic Conference, the main clinical diagnosis is ischemic stroke (cerebral infarction), 1 point ≤ NIHSS ≤ 24 points, and mRS ≤ 3 points; or ② Cerebral small vessel disease, according to the results of conventional sequence MRI examination, Fazekas score on T2 FLAIR sequence ≥ 3 points (0-6 points, the sum of paraventricular WMH score + subcortical WMH score), and mRS ≤ 3 points (mRS ≤ 4 points for those with recent subcortical small infarction within 1 month).
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  • Neurological examination showed stability within 30 days before baseline (visit 1).
  • Healthy cohort:
  • Age ≥ 18 years old when signing the informed consent form
  • Healthy adult subjects without underlying diseases

Who cannot join

  • Medical History and Current Health Status 1.1. Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.
  • 1.2. Any untreated teratoma or thymoma at the baseline visit (randomization) 1.3. Other causes of symptoms, including CNS infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.
  • 1.4. History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.
  • 1.6. Planned surgery during the study (except minor surgery). 1.7. History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.
  • 1.8. Current or history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at least 12 months prior to Day -1). Subjects with cancer remission for more than 5 years prior to baseline (Visit 1) may be included after discussion with the sponsor/sponsor approval.
  • 1.9. A history of gastrointestinal surgery (except appendectomy or cholecystectomy performed more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant active gastrointestinal diseases in the opinion of the investigator.
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  • 1.10. A history of clinically significant recurrent or active gastrointestinal symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, including the need to start symptomatic treatment (e.g., start medication for gastroesophageal reflux disease) or a change in symptomatic treatment within 90 days before screening (e.g., dose increase).
  • 1.11. A history of diverticulitis or concurrent severe gastrointestinal (GI) abnormalities (e.g., symptomatic diverticular disease) because the investigator believes that this may lead to an increased risk of complications such as GI perforation.
  • 1.12. A history of blood donation (1 unit or more), plasma donation, or platelet donation within 90 days before screening.
  • 1.13. Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.
  • 1.14. Based on the investigator's judgment, there are serious diseases or abnormalities in the clinical laboratory test results that prevent the patient from completing the study or participating in the study safely.
  • 1.15. Pregnant or lactating, or planning to become pregnant during the study or within 3 months after the last dose of the study drug; women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the start of the study.
  • 1.16. The subject's mental or physical condition will hinder the evaluation of efficacy and safety.
  • 1.17. Systolic blood pressure >150 mmHg or <90 mmHg after sitting still for 5 minutes or before dosing at screening. If out of range, it can be measured again at screening and before dosing. If the repeated measurement value is still out of range, the subject shall not receive the drug.
  • 1.18. Subjects with second or third degree atrioventricular block or sick sinus syndrome, poorly controlled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction, or significant ECG abnormalities, including QTc>450 msec (male) or 470 msec (female), where QTc is determined based on the Fridericia correction method, within 3 months prior to the screening visit.
  • 1.19. Planned elective procedures or surgeries at any time after signing the ICF by follow-up visit.
  • 1.20. Any condition that affects the absorption of study treatment (e.g., gastrectomy).
  • 1.21. History of hypersensitivity to heparin or history of heparin-induced thrombocytopenia.
  • 1.22. Subjects with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.
  • Risk of infection 2.1. History of human immunodeficiency virus (HIV) or positive test results at screening.
  • 2.2. Current infection with hepatitis C (defined as positive HCV antibodies and detectable HCV RNA). Subjects with positive HCV antibodies and HCV RNA below the limit of detection are eligible to participate in the study.
  • 2.3. Current infection with hepatitis B (defined as positive HBsAg and/or positive total anti-HBc). Subjects who are immune to hepatitis B after previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.
  • 2.4. Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).
  • 2.5. History of TB diagnosis or positive latent TB test result (defined as positive IGRA test result or 2 consecutive times.
  • 2.6. Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). Subjects with localized fungal infection (e.g., candidiasis, tinea) are eligible for rescreening after successful treatment of the infection.
  • 2.7. Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.
  • 2.8. Any live or live attenuated vaccine within 28 days prior to baseline (visit 1) or planned during the study.
  • 2.9. Contraindications to all of the following salvage therapies: rituximab, IVIG, high-dose corticosteroids, or IV cyclophosphamide.
  • 2.10. History of or receipt of the following treatments:
  • Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time.
  • Stem cell transplantation at any time.
  • Laboratory Values 3.1. Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).
  • 3.2. Any of the following blood test abnormalities at Screening:
  • WBC < 3.0 × 103/µL
  • ANC < 2.0 × 103/µL
  • Absolute lymphocyte count < 0.5 × 103/µL
  • Platelet count < × 10 × 104/µL
  • ALT, AST, or GGT ≥ 3 x ULN or bilirubin > 2 x ULN
  • eGFR ≤ 60 mL/min/1.73 m2
  • Lymphocyte count < LLN 3.3. Any of the following urine test abnormalities at Screening:
  • <!-- -->
  • β-2-microglobulin>0.3 μg/mL
  • Albumin/creatinine ratio>22.6 mg/mmol
  • Others 4.1. Previous participation in this study. 4.2. Blood donation (1 unit or more) within 90 days before screening, plasma donation within 1 week before screening, and platelet donation within 6 weeks before screening.
  • 4.3. History of alcohol or drug abuse in the past year (determined by the investigator).
  • 4.4. Pregnant or lactating subjects, as well as subjects planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.
  • 4.5. Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.
  • 4.6. History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by C-SSRS at screening.
  • 4.7. Unwilling or unable to comply with protocol requirements. 4.8. The patient has obvious hearing or vision impairment, language barriers, claustrophobia, etc., which makes the patient unable to cooperate with the neuropsychological scale assessment and MRI examination.
  • 4.9. The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ke Shang, MD contact

86-27-83663337

kay_sang@qq.com

Ke Shang, MD contact

86-27-83663332

kay_sang@hust.edu.cn

China2 sites, 2 recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Ke Shang, MD, 86-27-83663337, kay_sang@qq.com

    Ke Shang, MD, 86-27-83663333, kay_sang@hust.edu.cn

    Recruiting

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Ke Shang, PhD, 8683663477, kay_sang@qq.com

    Recruiting

Other trials in China

About this study

Official title: An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease

The most common cause of death for Chinese patients is ischemic cerebrovascular diseases(ICVD), particularly cerebral infarction. It places a heavy burden on people, families, and society as a whole and poses considerable risks of death and disability. The disease known as CSVD has a subtle beginning, is difficult to identify, and is frequently detected only after it progresses to the point of vascular cognitive dysfunction. The primary ischemia necrosis of brain nerve cells and the activation of inflammatory cells are their pathologic processes.

According to historical Chinese medical documents, bezoar possesses properties that can help prevent seizures, treat strokes, enhance cognitive function and mental well-being, and stimulate alertness. Calculus Bovis Sativus (CBS) is the most authentic formulation of bezoar ingredients compared to other bezoar products. It has received approval from the China Food and Drug Administration for the essential treatment of comatose patients. CBS consists of three primary constituents: bilirubin, bile acids, and taurine. Scientific evidence has demonstrated that all of these components possess anti-inflammatory, antioxidant, and neuroprotective properties.

The investigators' objective is to carry out an investigator-initiated clinical study to assess the efficacy of orally administered CBS in treating ischemic cerebrovascular diseases in humans.

Being tested
Calculus bovis sativus (CBS)
Keywords
Calculus Bovis Sativus, Neuroprotection, Neuroinflammation
Medical subject headings
Ischemic Stroke, Cerebral Small Vessel Diseases, Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calculus bovis sativus (CBS)Drug

    Subjects will orally receive 100mg CBS per day from day 1 to day 84.

Study groups in NCT06474507
Study groupRoleWhat they receive
CBS therapy, CBS dosage: 100mg per day from day 1 to day 84, in ICVD cohortExperimentalSubjects in ICVD cohort of this arm will receive general therapy plus CBS.
Receives: Drug: Calculus bovis sativus (CBS)
Control therapy: no intervention, in ICVD cohort.No interventionSubjects in ICVD cohort of this arm will only receive general therapy.
CBS therapy, CBS dosage: 100mg per day from day 1 to day 84, in healthy cohortExperimentalSubjects in healthy cohort of this arm will only receive CBS.
Receives: Drug: Calculus bovis sativus (CBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Modified Rankin Scale (mRS)

    To assess mRS of subjects within 12 weeks after treatment initiation

    Measured: Up to 12 weeks after treatment initiation

  2. The National Institutes of Health Stroke Scale, NIHSS

    To assess NIHSS of subjects within 12 weeks after treatment initiation

    Measured: Up to 12 weeks after treatment initiation

  3. Incidence and Severity of AEs and SAEs

    To evaluate the incidence of AEs and SAEs occurred within 14 weeks after treatment initiation

    Measured: Up to 14 weeks after treatment initiation

Secondary outcomes (11)

  1. The number of newly increased cerebral infarction on diffusion-weighted imaging at week 12 compared with baseline (visit 1) and control group.

    Measured: Up to 12 weeks after treatment initiation

  2. The number of lacunes on T1 weighted imaging at week 12 compared with baseline (visit 1) and control group.

    Measured: Up to 12 weeks after treatment initiation

  3. The number of white matter hyper-intensities on T2 flair weighted imaging at week 12 compared with baseline (visit 1) and control group.

    Measured: Up to 12 weeks after treatment initiation

  4. The number of cerebral microbleeds on susceptibility weighted imaging at week 12 compared with baseline (visit 1) and control group.

    Measured: Up to 12 weeks after treatment initiation

  5. The score of Mini-mental State Examination (MMSE) at week 12 compared with baseline (visit 1) and control group.

    The score of MMSE ranges from 0 to 30, and 30 represents the best.

    Measured: Up to 12 weeks after treatment initiation

  6. The score of Montreal cognitive assessment scale (MoCA) at week 12 compared with baseline (visit 1) and control group.

    The score of MoCA ranges from 0 to 30, and 30 represents the best.

    Measured: Up to 12 weeks after treatment initiation

  7. The score of subjective cognitive decline questionnaire (SCD) at week 12 compared with baseline (visit 1) and control group.

    The score of SCD ranges from 0 to 9, and 9 represents the worst.

    Measured: Up to 12 weeks after treatment initiation

  8. The score of Hamilton Anxiety Scale at week 12 compared with baseline (visit 1) and control group.

    The score of Hamilton Anxiety Scale ranges from 0 to 56, and 56 represents the worst.

    Measured: Up to 12 weeks after treatment initiation

  9. The score of Hamilton Depression Scale at week 12 compared with baseline (visit 1) and control group.

    The score of Hamilton Depression Scale ranges from 0 to 81, and 81 represents the worst.

    Measured: Up to 12 weeks after treatment initiation

  10. The score of 36-item Short-Form (SF-36) at week 12 compared with baseline (visit 1) and control group.

    The score of SF-36 ranges from 0 to 100, and 100 represents the best.

    Measured: Up to 12 weeks after treatment initiation

  11. The incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) events at week 14 compared with baseline (visit 1) and control group

    Measured: Up to 14 weeks after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start8 Aug 2024
  3. Primary completionJul 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474507
Sponsor's protocol ID
CBSinICVD
Status last verified
Sep 2024
First submitted
2 Jun 2024
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fu WJ, Lei T, Yin Z, Pan JH, Chai YS, Xu XY, Yan YX, Wang ZH, Ke J, Wu G, Xu RH, Paranjpe M, Qu L, Nie H. Anti-atherosclerosis and cardio-protective effects of the Angong Niuhuang Pill on a high fat and vitamin D3 induced rodent model of atherosclerosis. J Ethnopharmacol. 2017 Jan 4;195:118-126. doi: 10.1016/j.jep.2016.11.015. Epub 2016 Nov 20.

    PubMed 27880884

  • Zhou J, Jiang T, Wang J, Wu W, Duan X, Jiang H, Jiao Z, Wang X. Multimodal investigation reveals the neuroprotective mechanism of Angong Niuhuang pill for intracerebral hemorrhage: Converging bioinformatics, network pharmacology, and experimental validation. J Ethnopharmacol. 2024 Jan 30;319(Pt 1):117045. doi: 10.1016/j.jep.2023.117045. Epub 2023 Aug 24.

    PubMed 37633621

  • Yu ZJ, Xu Y, Peng W, Liu YJ, Zhang JM, Li JS, Sun T, Wang P. Calculus bovis: A review of the traditional usages, origin, chemistry, pharmacological activities and toxicology. J Ethnopharmacol. 2020 May 23;254:112649. doi: 10.1016/j.jep.2020.112649. Epub 2020 Feb 14.

    PubMed 32068140

  • Shi Y, Xiong J, Sun D, Liu W, Wei F, Ma S, Lin R. Simultaneous quantification of the major bile acids in artificial Calculus bovis by high-performance liquid chromatography with precolumn derivatization and its application in quality control. J Sep Sci. 2015 Aug;38(16):2753-62. doi: 10.1002/jssc.201500139. Epub 2015 Jun 30.

    PubMed 26016891

  • Shimada K, Azuma Y, Kawase M, Takahashi T, Schaffer SW, Takahashi K. Taurine as a marker for the identification of natural Calculus Bovis and its substitutes. Adv Exp Med Biol. 2013;776:141-9. doi: 10.1007/978-1-4614-6093-0_15.

    PubMed 23392879

  • Li X, Yao Y, Chen M, Ding H, Liang C, Lv L, Zhao H, Zhou G, Luo Z, Li Y, Zhang H. Comprehensive evaluation integrating omics strategy and machine learning algorithms for consistency of calculus bovis from different sources. Talanta. 2022 Jan 15;237:122873. doi: 10.1016/j.talanta.2021.122873. Epub 2021 Sep 30.

    PubMed 34736706

  • Liu Y, Tan P, Liu S, Shi H, Feng X, Ma Q. A new method for identification of natural, artificial and in vitro cultured Calculus bovis using high-performance liquid chromatography-mass spectrometry. Pharmacogn Mag. 2015 Apr-Jun;11(42):304-10. doi: 10.4103/0973-1296.153083.

    PubMed 25829769

  • Tang Y, Han Z, Zhang H, Che L, Liao G, Peng J, Lin Y, Wang Y. Characterization of Calculus bovis by principal component analysis assisted qHNMR profiling to distinguish nefarious frauds. J Pharm Biomed Anal. 2023 May 10;228:115320. doi: 10.1016/j.jpba.2023.115320. Epub 2023 Mar 1.

    PubMed 36871364

  • Takahashi K, Azuma Y, Shimada K, Saito T, Kawase M, Schaffer SW. Quality and safety issues related to traditional animal medicine: role of taurine. J Biomed Sci. 2010 Aug 24;17 Suppl 1(Suppl 1):S44. doi: 10.1186/1423-0127-17-S1-S44.

    PubMed 20804621

  • Lu F, Wang L, Chen Y, Zhong X, Huang Z. In vitro cultured calculus bovis attenuates cerebral ischaemia-reperfusion injury by inhibiting neuronal apoptosis and protecting mitochondrial function in rats. J Ethnopharmacol. 2020 Dec 5;263:113168. doi: 10.1016/j.jep.2020.113168. Epub 2020 Jul 27.

    PubMed 32730869

  • Zhong XM, Ren XC, Lou YL, Chen MJ, Li GZ, Gong XY, Huang Z. Effects of in-vitro cultured calculus bovis on learning and memory impairments of hyperlipemia vascular dementia rats. J Ethnopharmacol. 2016 Nov 4;192:390-397. doi: 10.1016/j.jep.2016.09.014. Epub 2016 Sep 9.

    PubMed 27616028

  • Vitek L, Tiribelli C. Bilirubin: The yellow hormone? J Hepatol. 2021 Dec;75(6):1485-1490. doi: 10.1016/j.jhep.2021.06.010. Epub 2021 Jun 18.

    PubMed 34153399

  • Thakkar M, Edelenbos J, Dore S. Bilirubin and Ischemic Stroke: Rendering the Current Paradigm to Better Understand the Protective Effects of Bilirubin. Mol Neurobiol. 2019 Aug;56(8):5483-5496. doi: 10.1007/s12035-018-1440-y. Epub 2019 Jan 5.

    PubMed 30612336

  • Vasavda C, Kothari R, Malla AP, Tokhunts R, Lin A, Ji M, Ricco C, Xu R, Saavedra HG, Sbodio JI, Snowman AM, Albacarys L, Hester L, Sedlak TW, Paul BD, Snyder SH. Bilirubin Links Heme Metabolism to Neuroprotection by Scavenging Superoxide. Cell Chem Biol. 2019 Oct 17;26(10):1450-1460.e7. doi: 10.1016/j.chembiol.2019.07.006. Epub 2019 Jul 25.

    PubMed 31353321

  • Liu HW, Gong LN, Lai K, Yu XF, Liu ZQ, Li MX, Yin XL, Liang M, Shi HS, Jiang LH, Yang W, Shi HB, Wang LY, Yin SK. Bilirubin gates the TRPM2 channel as a direct agonist to exacerbate ischemic brain damage. Neuron. 2023 May 17;111(10):1609-1625.e6. doi: 10.1016/j.neuron.2023.02.022. Epub 2023 Mar 14.

    PubMed 36921602

Questions about this trial

What is this clinical trial studying?

A study testing Calculus bovis sativus (CBS) in people with Ischemic Cerebrovascular Disease and Acute Ischemic Stroke, run by Tongji Hospital at 2 sites 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 10 inclusion and 50 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: looking for participants now, as of the sponsor's last update on 20 Sep 2024. 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 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.

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 Ke Shang, MD (86-27-83663337, kay_sang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Modified Rankin Scale (mRS) (time frame: Up to 12 weeks after treatment initiation). The study lists 3 primary outcomes in all. 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 NCT06474507, which also lists 24 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 Sep 2024.

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