SyphilisNCT06082453
Modernizing Perinatal Syphilis Testing
A study testing Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum and Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum in people with Syphilis, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
Trial summary
The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to… Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Syphilis
- What is being tested?
- Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum and Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 924 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 May 2023to 30 Nov 2027
- 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 Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth
- Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis
Who cannot join
- Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
- Planning to move outside of study prior to ND testing
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Jeanne Sheffield, MD, 443-997-0400, jsheffi2@jhmi.edu
Chris Golden, MD, 410-995-5259, cgolden@jhmi.edu
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Alison Pritchard, PhD, 443-923-9200, pritchard@kennedykrieger.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Pablo Sanchez, 614-722-4559, pablo.sanchez@nationwidechildrens.org
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Martha Rac, MD, 832-826-7500, martha.rac@bcm.edu
Ryan Rochat, MD, PhD, 936-262-0726, rochat@bcm.edu
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Lisa Noll, PhD, 832-822-3700, lmnoll@texaschildrens.org
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Norma Perez, DO, 832-325-6516, norma.perez@uth.tmc.edu
- Recruiting
Christus Health
Houston, Texas, 78130
James Hill, MD, 210-704-3200, james.hill2@christushealth.org
- Recruiting
University of Southern California
Los Angeles, California, 90007
Brendan Grubbs, MD, 323-361-6078, Brendan.grubbs@med.usc.edu
Alice Stek, MD, 323-226-3353, stek@usc.edu
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Karin Best, PhD, 310-267-1908, kbest@mednet.ucla.edu
About this study
The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.
- Conditions
- Syphilis
- Being tested
- Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum, Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum, Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidumDiagnostic test
A quantitative polymerase chain reaction (qPCR) assay detects and quantifies DNA in a sample, and the qPCR assay used in this study targets the polA gene of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. qPCR data will only be used to determine testing performance and will not be used in clinical management of study participants.
Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidumDiagnostic test
The Aptima transcription-mediated amplification (TMA) assay used in this study will target RNA of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. TMA data will only be used to determine testing performance and will not be used in clinical management of study participants.
Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilisOther
Using the Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines, new born syphilis infection is categorized by clinical providers at birth as follows: confirmed proven/highly probably, possible congenital syphilis (CS), CS less likely, or CS unlikely. These CS categories are determined using neonatal nontreponemal test results, physical exam of the infant, placental pathology, and maternal serologies and treatment history, and comparison of maternal and neonatal nontreponemal tiers. These data will be collected as part of standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis | Experimental | Not described Receives: Diagnostic Test: Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum; Diagnostic Test: Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum; Other: Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 96 hours after birth
Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Samples will be collected from participants during the following time periods:
from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Measured: from the time of birth up to 72 hours after birth
Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Measured: from 12 weeks gestational age up to 18 months after birth
Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Measured: from 12 weeks gestational age up to 18 months after birth
Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Measured: from 12 weeks gestational age up to 18 months after birth
Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Measured: from 12 weeks gestational age up to 18 months after birth
Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Measured: from 12 weeks gestational age up to 18 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start2 May 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 924 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Irene Stafford, The University of Texas Health Science Center, Houston
- Investigators
- Irene Stafford, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082453
- Sponsor's protocol ID
- HSC-MS-21-0731
- Other IDs
- R01HD108201
- Status last verified
- Oct 2025
- First submitted
- 9 Oct 2023
- Last updated
- 3 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modernizing Perinatal Syphilis Testing
- ClinicalTrials.gov ID
- NCT06082453
- Acronym / sponsor ID
- HSC-MS-21-0731
- Conditions
- Syphilis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 924 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 13 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.
The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis | Experimental | Diagnostic Test: Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum, Diagnostic Test: Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum, Other: Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth
- Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis
Key exclusion criteria (2 listed)
- Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
- Planning to move outside of study prior to ND testing
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 |
|---|---|---|
| Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidumA quantitative polymerase chain reaction (qPCR) assay detects and quantifies DNA in a sample, and the qPCR assay used in this study targets the polA gene of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. qPCR data will only be used to determine testing performance and will not be used in clinical management of study participants. | Diagnostic test | Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis |
| Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidumThe Aptima transcription-mediated amplification (TMA) assay used in this study will target RNA of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. TMA data will only be used to determine testing performance and will not be used in clinical management of study participants. | Diagnostic test | Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis |
| Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilisUsing the Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines, new born syphilis infection is categorized by clinical providers at birth as follows: confirmed proven/highly probably, possible congenital syphilis (CS), CS less likely, or CS unlikely. These CS categories are determined using neonatal nontreponemal test results, physical exam of the infant, placental pathology, and maternal serologies and treatment history, and comparison of maternal and neonatal nontreponemal tiers. These data will be collected as part of standard clinical care. | Other | Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis |
Primary outcome
Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Time frame: from the time of birth up to 96 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Time frame: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Time frame: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Time frame: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Time frame: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Time frame: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Time frame: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
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 3 Nov 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.
Irene Stafford, MD principal investigator
The University of Texas Health Science Center, Houston
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum and Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum in people with Syphilis, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
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 2 inclusion and 2 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 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 Irene Stafford, MD ((713) 500-6412, Irene.Stafford@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum (time frame: from the time of birth up to 96 hours after birth). The study lists 15 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 3 Nov 2025.