EosinophiliaEosinophiliaNCT06265870
Specific Versus Empirical Anthelminthic Treatment in Eosinophilia
A study testing Albendazole and Ivermectin or albendazole in people with Eosinophilia, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilia
- What is being tested?
- Albendazole and Ivermectin or albendazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Interventional
- 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
- Participants who come for check-ups at general practitioner, primary care unit, and Srivejchavat Premium Center have an absolute eosinophil count greater than 500 cells/microliter with a white blood cell count less than 10,000 cells/microliter.
- Age at least 18 years old
- Consent to participate in research
Who cannot join
- Having any characteristics that need urgent care 1.1 Having history of unintended significant weight loss is defined as the loss of body weight exceeding 10% within a span of six months without deliberate attention.
- 1.2 Physical examination revealed a body temperature equal to or greater than 37.8 degrees Celsius, lymphadenopathy or hepatosplenomegaly.
- 1.3 CBC revealed blast cell
- Receiving anthelminthic drug within 6 months
- Underlying cancer (active stage), HIV, HBV, HCV, collagen vascular disease, active TB
- Allergy to albendazole, ivermectin, or metronidazole
Show all 9Show fewer
- Pregnancy or lactation
- Serum transaminase higher than 2 times of upper normal limit
- Taking medications that may induce eosinophilia within the past three months, such as herbal supplements, NSAIDs, Salicylic acid, Carbamazepine, Colchicine, Nitrofurantoin, Dapsone, or Minocycline, was reported.
Trial locations and contacts
1 site in 1 country.
Wisarut Srisintorn contact
Thailand1 site, 1 recruiting
- Recruiting
Prince of Songkla University - Hat Yai Campus: Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
Thareerat Ananchaisarp
About this study
Official title: Comparison of Outcome Between Specific Anthelminthic Treatment According to Test Results and Empirical Anthelminthic Treatment in Eosinophilic Patient
There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. In cases where parasite infection is suspected, particularly in developing countries, stool microscopy and serology are recommended. However, limitations such as low sensitivity of stool microscopy, the inconvenience of collecting multiple stool samples, and the high cost and unavailability of serology may arise. Consequently, some physicians opt for empiric anthelminthic regimens in managing eosinophilic patients, even without stool tests or if stool test results are normal. If subsequent complete blood count (CBC) results show a recovery of absolute eosinophil count, it is assumed that eosinophilia was caused by a parasite infection. While some studies demonstrate the efficacy and simplicity of this approach, there is a risk of overestimating parasite infection in eosinophilic patients, potential adverse drug reactions from unnecessary anthelminthic treatment, and the possibility of drug resistance due to inappropriate dosing. To address this gap, no study has yet compared the efficacy between specific anthelminthic treatment based on test results and empirical anthelminthic treatment in eosinophilic patients. Therefore, the investigators are conducting this study.
Read the detailed description
Eosinophilia is defined as an absolute eosinophil count exceeding 500 cells per microliter, calculated by multiplying the white blood cell count by the percentage of eosinophils.
Cause of eosinophilia vary from mild to life-threatening disease. Prevalence of each cause of eosinophilia vary on study population, the most common etiology in developing country is parasite infection.
Stool microscopy can be conducted using various methods. The Kato-Katz technique, recommended by the WHO, exhibits a sensitivity of only 52.4 percent (95%CI = 47.6 - 57.1 percent). More sensitive methods for parasite detection in stool, such as stool culture or PCR, are not readily available and can be costly. In the intervention group of this study, the investigators employed three different parasite detection methods (stool microscopy, stool culture, and PCR) to enhance sensitivity in detecting parasites.
- Conditions
- Eosinophilia
- Being tested
- Albendazole, Ivermectin or albendazole
- Keywords
- eosinophilia, anthelminthic drugs, empirical treatment, stool examination
- Medical subject headings
- Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Participants receive empiric anthelminthic treatment which is albendazole 400 mg twice a day for seven consecutive days
Ivermectin or albendazoleDrug
Participants will receive specific anthelminthic treatment tailored to the results of the stool tests
| Study group | Role | What they receive |
|---|---|---|
| Specific anthelminthic | Active comparator | Participants were asked to provide stool samples for three consecutive days for testing through microscopy, culture, and PCR to detect parasites.
* This study will combine wet smear and Kato's thick smear methods, with duplicate samples collected from each stool specimen to maximize parasite detection. To ensure reliability, two experienced microscopists will independently examine all four slides, and an independent report generated. In cases of discrepant results, a third microscopist will arbitrate, and the final diagnosis determined by majority vote.
* Stool culture will look for Strongyloides stercoralis and hookworm larvae.
* Stool PCR: Targeted gene of 7 helminths will be amplified and detected by multiplex real-time PCR. The reaction will be dividing into three assays.
Following the analysis of the stool samples, participants will receive specific anthelminthic treatment tailored to the results of the stool tests. Receives: Drug: Ivermectin or albendazole |
| Empirical anthelminthic | Placebo comparator | Participants will receive an empirical anthelminthic regimen consisting of albendazole 400 mg twice a day for seven consecutive days. Following this treatment, a follow-up complete blood count (CBC) will be requested to assess responsiveness. Receives: Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophilia recovery
Recovery from eosinophilia was defined as an absolute eosinophil count of less than 500 cells per microliter, as measured from the complete blood count (CBC) four weeks after receiving anthelminthic treatment.
Measured: From receive anthelminthic treatment to the end of treatment at 4 weeks
Secondary outcomes (1)
Change in AEC
Comparing the change in AEC from baseline between the \"specific treatment group\" and the \"empirical treatment group\" using either a paired t-test or the Wilcoxon signed-rank test.
Measured: From receive anthelminthic treatment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for EosinophiliaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thareerat Ananchaisarp, Prince of Songkla University
- Investigators
- Thareerat Ananchaisarp, Principal investigator, Prince of Songkla University - Hat Yai Campus: Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265870
- Sponsor's protocol ID
- Parasite in Eosinophilia
- Acronym
- Eosinophilia
- Status last verified
- Sep 2024
- First submitted
- 10 Feb 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analyzed during the current study are available at primary researcher and may share with author research on reasonable request.
Publications
Chanswangphuwana C, Uaprasert N, Moonla C, Rojnuckarin P. Causes and outcomes of hypereosinophilia in a tropical country. Asian Pac J Allergy Immunol. 2024 Dec;42(4):403-408. doi: 10.12932/AP-221220-1021.
PubMed 33865302Ananchaisarp T, Chamroonkiadtikun P, Julamanee J, Perdvong K, Chimpalee T, Rattanavirakul N, Leelarujijaroen N, Hathaipitak T, Tantinam T. Prevalence and management of eosinophilia based on periodic health examinations in primary care clinics. Asian Biomed (Res Rev News). 2023 Jun 16;16(5):273-282. doi: 10.2478/abm-2022-0030. eCollection 2022 Oct.
PubMed 37551315Shomali W, Gotlib J. World Health Organization-defined eosinophilic disorders: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Jan 1;97(1):129-148. doi: 10.1002/ajh.26352. Epub 2021 Oct 8.
PubMed 34533850Butt NM, Lambert J, Ali S, Beer PA, Cross NC, Duncombe A, Ewing J, Harrison CN, Knapper S, McLornan D, Mead AJ, Radia D, Bain BJ; British Committee for Standards in Haematology. Guideline for the investigation and management of eosinophilia. Br J Haematol. 2017 Feb;176(4):553-572. doi: 10.1111/bjh.14488. Epub 2017 Jan 23. No abstract available.
PubMed 28112388Magnaval JF, Laurent G, Gaudre N, Fillaux J, Berry A. A diagnostic protocol designed for determining allergic causes in patients with blood eosinophilia. Mil Med Res. 2017 May 23;4:15. doi: 10.1186/s40779-017-0124-7. eCollection 2017.
PubMed 28546866Vaisben E, Brand R, Kadakh A, Nassar F. The role of empirical albendazole treatment in idiopathic hypereosinophilia - a case series. Can J Infect Dis Med Microbiol. 2015 Nov-Dec;26(6):323-4. doi: 10.1155/2015/531675.
PubMed 26744590Insiripong S, Siriyakorn N. Treatment of eosinophilia with albendazole. Southeast Asian J Trop Med Public Health. 2008 May;39(3):517-20.
PubMed 18564693Chen B, Fu Y, Wang Z, Rong Q, Zhang Q, Xie J, Kong X, Jiang M. Eosinophilia attention, diagnosis, treatment, and awareness in physicians: a cross-sectional survey. Ther Adv Chronic Dis. 2023 Jan 24;14:20406223221146938. doi: 10.1177/20406223221146938. eCollection 2023.
PubMed 36712467Kim DW, Shin MG, Yun HK, Kim SH, Shin JH, Suh SP, Ryang DW. [Incidence and causes of hypereosinophilia (corrected) in the patients of a university hospital]. Korean J Lab Med. 2009 Jun;29(3):185-93. doi: 10.3343/kjlm.2009.29.3.185. Korean.
PubMed 19571614Wardlaw AJ, Wharin S, Aung H, Shaffu S, Siddiqui S. The causes of a peripheral blood eosinophilia in a secondary care setting. Clin Exp Allergy. 2021 Jul;51(7):902-914. doi: 10.1111/cea.13889. Epub 2021 Jun 3.
PubMed 34080735Tefferi A, Patnaik MM, Pardanani A. Eosinophilia: secondary, clonal and idiopathic. Br J Haematol. 2006 Jun;133(5):468-92. doi: 10.1111/j.1365-2141.2006.06038.x.
PubMed 16681635Guo C, Bochner BS. Workup for eosinophilia. Allergy Asthma Proc. 2019 Nov 1;40(6):429-432. doi: 10.2500/aap.2019.40.4264.
PubMed 31690387Kuang FL. Approach to Patients with Eosinophilia. Med Clin North Am. 2020 Jan;104(1):1-14. doi: 10.1016/j.mcna.2019.08.005.
PubMed 31757229Rosenwasser LJ. Approach to patients with eosinophilia. Mo Med. 2011 Sep-Oct;108(5):358-60.
PubMed 22073495Simon D, Simon HU. Eosinophilic disorders. J Allergy Clin Immunol. 2007 Jun;119(6):1291-300; quiz 1301-2. doi: 10.1016/j.jaci.2007.02.010. Epub 2007 Apr 2.
PubMed 17399779
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome Between Specific Anthelminthic Treatment According to Test Results and Empirical Anthelminthic Treatment in Eosinophilic Patient
- ClinicalTrials.gov ID
- NCT06265870
- Acronym / sponsor ID
- Eosinophilia / Parasite in Eosinophilia
- Conditions
- Eosinophilia
- Keywords
- eosinophilia, anthelminthic drugs, empirical treatment, stool examination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 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.
There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. In cases where parasite infection is suspected, particularly in developing countries, stool microscopy and serology are recommended. However, limitations such as low sensitivity of stool microscopy, the inconvenience of collecting multiple stool samples, and the high cost and unavailability of serology may arise. Consequently, some physicians opt for empiric anthelminthic regimens in managing eosinophilic patients, even without stool tests or if stool test results are normal. If subsequent complete blood count (CBC) results show a recovery of absolute eosinophil count, it is assumed that eosinophilia was caused by a parasite infection. While some studies demonstrate the efficacy and simplicity of this approach, there is a risk of overestimating parasite infection in eosinophilic patients, potential adverse drug reactions from unnecessary anthelminthic treatment, and the possibility of drug resistance due to inappropriate dosing. To address this gap, no study has yet compared the efficacy between specific anthelminthic treatment based on test results and empirical anthelminthic treatment in eosinophilic patients. Therefore, the investigators are conducting this study.
Detailed description
Eosinophilia is defined as an absolute eosinophil count exceeding 500 cells per microliter, calculated by multiplying the white blood cell count by the percentage of eosinophils.
Cause of eosinophilia vary from mild to life-threatening disease. Prevalence of each cause of eosinophilia vary on study population, the most common etiology in developing country is parasite infection.
Stool microscopy can be conducted using various methods. The Kato-Katz technique, recommended by the WHO, exhibits a sensitivity of only 52.4 percent (95%CI = 47.6 - 57.1 percent). More sensitive methods for parasite detection in stool, such as stool culture or PCR, are not readily available and can be costly. In the intervention group of this study, the investigators employed three different parasite detection methods (stool microscopy, stool culture, and PCR) to enhance sensitivity in detecting parasites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific anthelminthic | Active comparator | Drug: Ivermectin or albendazoleParticipants were asked to provide stool samples for three consecutive days for testing through microscopy, culture, and PCR to detect parasites. * This study will combine wet smear and Kato's thick smear methods, with duplicate samples collected from each stool specimen to maximize parasite detection. To ensure reliability, two experienced microscopists will independently examine all four slides, and an independent report generated. In cases of discrepant results, a third microscopist will arbitrate, and the final diagnosis determined by majority vote. * Stool culture will look for Strongyloides stercoralis and hookworm larvae. * Stool PCR: Targeted gene of 7 helminths will be amplified and detected by multiplex real-time PCR. The reaction will be dividing into three assays. Following the analysis of the stool samples, participants will receive specific anthelminthic treatment tailored to the results of the stool tests. |
| Empirical anthelminthic | Placebo comparator | Drug: AlbendazoleParticipants will receive an empirical anthelminthic regimen consisting of albendazole 400 mg twice a day for seven consecutive days. Following this treatment, a follow-up complete blood count (CBC) will be requested to assess responsiveness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who come for check-ups at general practitioner, primary care unit, and Srivejchavat Premium Center have an absolute eosinophil count greater than 500 cells/microliter with a white blood cell count less than 10,000 cells/microliter.
- Age at least 18 years old
- Consent to participate in research
Key exclusion criteria (9 listed)
- Having any characteristics that need urgent care 1.1 Having history of unintended significant weight loss is defined as the loss of body weight exceeding 10% within a span of six months without deliberate attention.
- 1.2 Physical examination revealed a body temperature equal to or greater than 37.8 degrees Celsius, lymphadenopathy or hepatosplenomegaly.
- 1.3 CBC revealed blast cell
- Receiving anthelminthic drug within 6 months
- Underlying cancer (active stage), HIV, HBV, HCV, collagen vascular disease, active TB
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 |
|---|---|---|
| AlbendazoleParticipants receive empiric anthelminthic treatment which is albendazole 400 mg twice a day for seven consecutive days | Drug | Empirical anthelminthic |
| Ivermectin or albendazoleParticipants will receive specific anthelminthic treatment tailored to the results of the stool tests | Drug | Specific anthelminthic |
Primary outcome
Eosinophilia recovery
Time frame: From receive anthelminthic treatment to the end of treatment at 4 weeks
Recovery from eosinophilia was defined as an absolute eosinophil count of less than 500 cells per microliter, as measured from the complete blood count (CBC) four weeks after receiving anthelminthic treatment.
1 secondary outcome
Change in AEC
Time frame: From receive anthelminthic treatment to the end of treatment at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Results publication: PubMed 33865302Chanswangphuwana C, Uaprasert N, Moonla C, Rojnuckarin P. Causes and outcomes of hypereosinophilia in a tropical country. Asian Pac J Allergy Immunol. 2024 Dec;42(4):403-408. doi: 10.12932/AP-221220-1021.
- Results publication: PubMed 37551315Ananchaisarp T, Chamroonkiadtikun P, Julamanee J, Perdvong K, Chimpalee T, Rattanavirakul N, Leelarujijaroen N, Hathaipitak T, Tantinam T. Prevalence and management of eosinophilia based on periodic health examinations in primary care clinics. Asian Biomed (Res Rev News). 2023 Jun 16;16(5):273-282. doi: 10.2478/abm-2022-0030. eCollection 2022 Oct.
- Results publication: PubMed 34533850Shomali W, Gotlib J. World Health Organization-defined eosinophilic disorders: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Jan 1;97(1):129-148. doi: 10.1002/ajh.26352. Epub 2021 Oct 8.
- Results publication: PubMed 28112388Butt NM, Lambert J, Ali S, Beer PA, Cross NC, Duncombe A, Ewing J, Harrison CN, Knapper S, McLornan D, Mead AJ, Radia D, Bain BJ; British Committee for Standards in Haematology. Guideline for the investigation and management of eosinophilia. Br J Haematol. 2017 Feb;176(4):553-572. doi: 10.1111/bjh.14488. Epub 2017 Jan 23. No abstract available.
- Results publication: PubMed 28546866Magnaval JF, Laurent G, Gaudre N, Fillaux J, Berry A. A diagnostic protocol designed for determining allergic causes in patients with blood eosinophilia. Mil Med Res. 2017 May 23;4:15. doi: 10.1186/s40779-017-0124-7. eCollection 2017.
- Results publication: PubMed 26744590Vaisben E, Brand R, Kadakh A, Nassar F. The role of empirical albendazole treatment in idiopathic hypereosinophilia - a case series. Can J Infect Dis Med Microbiol. 2015 Nov-Dec;26(6):323-4. doi: 10.1155/2015/531675.
- Results publication: PubMed 18564693Insiripong S, Siriyakorn N. Treatment of eosinophilia with albendazole. Southeast Asian J Trop Med Public Health. 2008 May;39(3):517-20.
- Results publication: PubMed 36712467Chen B, Fu Y, Wang Z, Rong Q, Zhang Q, Xie J, Kong X, Jiang M. Eosinophilia attention, diagnosis, treatment, and awareness in physicians: a cross-sectional survey. Ther Adv Chronic Dis. 2023 Jan 24;14:20406223221146938. doi: 10.1177/20406223221146938. eCollection 2023.
- Results publication: PubMed 19571614Kim DW, Shin MG, Yun HK, Kim SH, Shin JH, Suh SP, Ryang DW. [Incidence and causes of hypereosinophilia (corrected) in the patients of a university hospital]. Korean J Lab Med. 2009 Jun;29(3):185-93. doi: 10.3343/kjlm.2009.29.3.185. Korean.
- Results publication: PubMed 34080735Wardlaw AJ, Wharin S, Aung H, Shaffu S, Siddiqui S. The causes of a peripheral blood eosinophilia in a secondary care setting. Clin Exp Allergy. 2021 Jul;51(7):902-914. doi: 10.1111/cea.13889. Epub 2021 Jun 3.
- Results publication: PubMed 16681635Tefferi A, Patnaik MM, Pardanani A. Eosinophilia: secondary, clonal and idiopathic. Br J Haematol. 2006 Jun;133(5):468-92. doi: 10.1111/j.1365-2141.2006.06038.x.
- Results publication: PubMed 31690387Guo C, Bochner BS. Workup for eosinophilia. Allergy Asthma Proc. 2019 Nov 1;40(6):429-432. doi: 10.2500/aap.2019.40.4264.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed during the current study are available at primary researcher and may share with author research on reasonable request.
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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.
Wisarut Srisintorn contact
Thareerat Ananchaisarp principal investigator
Prince of Songkla University - Hat Yai Campus: Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole and Ivermectin or albendazole in people with Eosinophilia, run by Prince of Songkla University at 1 site in Thailand.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 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 1 site in Thailand. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thareerat Ananchaisarp (66858898592, thareerat.a@psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eosinophilia recovery (time frame: From receive anthelminthic treatment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265870, which also lists 18 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 24 Sep 2024.