Autism Spectrum Disorder (ASD)Phase 2STAT-2ANCT06866275
Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)
A Phase 2 study testing KZ101 in people with Autism Spectrum Disorder (ASD), run by Children's Hospital of Orange County at 2 sites in United States.
Trial summary
Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise… Read more about this study
- Who is it for?
- Ages 5 to 14 years, men only
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- KZ101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2025to Apr 2028
- Phase
- Phase 2
- 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 5 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Subject must meet all of the following criteria to be enrolled in this study.
- Male, aged 5-14 years
- Clinical diagnosis of ASD by DSM-5 criteria
- ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).
- CGI-S ≥ 4 for socialization specific symptoms of ASD
- Leiter-3 non-verbal IQ > 70
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- Standard score < 75 on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition
- Subjects who are sexually active or potentially sexually active agree to use condoms with a spermicidal as a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study medication
- Subjects agree to wear sunscreen and to wear skin covering to the maximal degree tolerated by the child for the duration of the treatment period and for at least 30 days after the last dose of study medication
- Subjects must have a ≤ 90 minutes car ride from the study site
- English-speaking child and parent/guardian or caregiver
- Parent or their legal guardians must be willing to sign informed consent
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study.
- ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman, Down's Syndrome, etc.)
- ≤ 5th percentile for weight
- Unable to tolerate venipuncture or urine collection
- Acute infection (e.g., upper respiratory tract infection, common cold, flu, strep, COVID-19)
- Severe co-morbid conditions (e.g., psychosis, seizures/epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures. Controlled epilepsy is allowed providing there has not been a breakthrough seizure in the past year.
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- Any organ system dysfunction, especially liver (e.g., ALT or AST ≥ 1.5x the upper limit of normal), kidney (estimated glomerular filtration rate or eGFR < 90 mL/min/1.73 m2; hematuria confirmed by urine microscopy [ > 5 red blood cells/high power field]; proteinuria [> 1+ that does not resolve on repeat testing or urine protein to creatinine ratio > 0.3]; and/or presence of any granular, mixed cellular, red blood cell, white blood cell, or muddy brown casts on urine microscopy), or clinically relevant heart or adrenal abnormalities
- Hospitalization within the previous 2 months from screening
- Initiation or change in pharmacotherapy within previous 2 months from screening
- Initiation or change in psychosocial interventions (formal behavioral, cognitive, or cognitive-behavior therapy) within previous 2 months from screening
- Plan to initiate or change pharmacotherapy or psychosocial interventions during the study
- Taking prescription medication that may interact adversely with KZ101 or expose the subject to increased risk of harm such as medications with plasma bound substances including sulfonamides, chlorpromazine, and anti-coagulants
- Currently enrolled in another clinical study or has received any investigational treatment within 30 days of screening
- Taking > 3 medications addressing behavioral symptoms related to ASD (ie typical/atypical antipsychotics and alpha-adrenergic agonists) or comorbid medical conditions such as ADHD, anxiety, or depression. Anti-seizure medications and other medications not related to neurobehavioral symptoms do not count towards the total number of medications allowed.
- History of serious dermatological reactions
- History of allergy, intolerance, or photosensitivity to any drug
- Unable or unwilling to adhere to study requirements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Katie Kay, 443-923-3819, kayk@kennedykrieger.org
Karen Chen, 667-205-4393, chenk@kennedykrieger.org
- Recruiting
Children's Hospital Orange County, Thompson Autism and Neurodevelopmental Center
Orange, California, 92868
Adrienne R Moore, PhD, 714-288-7456, adrienne.moore@choc.org
Aram Kim, MD
About this study
Official title: Suramin for the Treatment of Autism Trial (STAT): A Randomized, Double Blind, Crossover Trial of KZ101 in a Male Pediatric Population With Autism Spectrum Disorder
Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.
Read the detailed description
After up to a 4-week screening period, participants will undergo 8 weeks of active or placebo treatment (Period 1), followed by an 8-week washout period, and then cross over to 8 weeks of placebo or active treatment (Period 2). Patients will be followed for 2 weeks after completion of Period 2. Two dosing groups are designated as Group A, who are randomly assigned to active treatment with KZ101 in Period 1 and saline in Period 2, and Group B, who are randomly assigned to saline infusion in Period 1 and active treatment with KZ101 in Period 2. Dosing in both periods will consist of 2 IV infusions of either saline (placebo) or KZ101 (active treatment), given 4 weeks apart.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- KZ101, Placebo
- Keywords
- Suramin, suramin sodium
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KZ101Drug
Also called Suramin, Suramin sodium
For active treatment with KZ101, a loading dose of 454 mg/m2 (salt-free) will be followed by a treatment dose of 363 mg/m2 (salt-free).
PlaceboDrug
Also called Saline
Dosing in the placebo group will consist of a volume of normal saline equivalent to that given during the active treatment period for each participant.
| Study group | Role | What they receive |
|---|---|---|
| Drug followed by Placebo | Experimental | Not described Receives: Drug: KZ101; Drug: Placebo |
| Placebo followed by Drug | Placebo comparator | Not described Receives: Drug: KZ101; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint - Vineland-3 Socialization Domain
The primary efficacy endpoint will be the change in standard score on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition (Vineland-3), which includes subdomains for coping skills, play skills, and interpersonal relation skills.
Measured: Change from Screening to Week 8 (before washout) will be compared to change from Week 16 to Week 24 (after washout).
Secondary outcomes (8)
Secondary Efficacy Endpoint - Vineland-3, Additional Scores
Vineland-3 Composite Score, Communication Domain Score, and Daily Living Skills Domain Score will also be assessed.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Global Impresssion, Severity/Change
Clinician Global Impression of Severity and Change, and Caregiver/Parent Global Impression of Severity and Change, will be collected and assessed weighted for socialization.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Social Responsiveness Scale-2
The Social Responsiveness Scale-2 (SRS-2) is a well-established tool to evaluate socialization that was also used in a prior pilot study.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Aberrant Behavior Checklist, Second Edition (ABC-2)
The ABC-2 provides measures of repetitive behaviors and includes domains of irritability, social withdrawal, stereotypy, hyperactivity, and inappropriate speech.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Childhood Sleep Habits Questionnaire (CSHQ)
As a large proportion of the adolescents with ASD population is highly impacted by sleep concerns, the CSHQ will be administered to investigate relationships between KZ101 and sleep.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Parenting Stress Impact (PSI)
Data from the PSI will be used to evaluate whether changes in symptoms in the ASD participant is associated with changes in parental stress throughout the study.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Child Behavior Check List (CBCL)
The CBCL is a parental measure of internalizing and externalizing behaviors as well as common DSM-5 conditions co-occurring with ASD.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Ohio State University Autism Rating Scale, 5th Edition
The Ohio State University Autism Rating Scale 5 (OARS-5) will provide three summary scores to be evaluated with KZ101 administration and placebo administration: autism symptom count, weighted mean severity score of autism symptoms, and impairment index based on level of support needed.
Measured: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start9 Apr 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Collaborators
- Kuzani Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Aram Kim, MD, Principal investigator, Thompson Autism and Neurodevelopmental Center, Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866275
- Sponsor's protocol ID
- CHOC IRB# 2308114
- Acronym
- STAT-2A
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD at this time.
Publications
Naviaux RK, Zolkipli Z, Wang L, Nakayama T, Naviaux JC, Le TP, Schuchbauer MA, Rogac M, Tang Q, Dugan LL, Powell SB. Antipurinergic therapy corrects the autism-like features in the poly(IC) mouse model. PLoS One. 2013;8(3):e57380. doi: 10.1371/journal.pone.0057380. Epub 2013 Mar 13.
PubMed 23516405Naviaux JC, Schuchbauer MA, Li K, Wang L, Risbrough VB, Powell SB, Naviaux RK. Reversal of autism-like behaviors and metabolism in adult mice with single-dose antipurinergic therapy. Transl Psychiatry. 2014 Jun 17;4(6):e400. doi: 10.1038/tp.2014.33.
PubMed 24937094Naviaux JC, Wang L, Li K, Bright AT, Alaynick WA, Williams KR, Powell SB, Naviaux RK. Antipurinergic therapy corrects the autism-like features in the Fragile X (Fmr1 knockout) mouse model. Mol Autism. 2015 Jan 13;6:1. doi: 10.1186/2040-2392-6-1. eCollection 2015.
PubMed 25705365Naviaux RK, Curtis B, Li K, Naviaux JC, Bright AT, Reiner GE, Westerfield M, Goh S, Alaynick WA, Wang L, Capparelli EV, Adams C, Sun J, Jain S, He F, Arellano DA, Mash LE, Chukoskie L, Lincoln A, Townsend J. Low-dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial. Ann Clin Transl Neurol. 2017 May 26;4(7):491-505. doi: 10.1002/acn3.424. eCollection 2017 Jul.
PubMed 28695149
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suramin for the Treatment of Autism Trial (STAT): A Randomized, Double Blind, Crossover Trial of KZ101 in a Male Pediatric Population With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06866275
- Acronym / sponsor ID
- STAT-2A / CHOC IRB# 2308114
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Suramin, suramin sodium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Collaborators
- Kuzani Pharmaceuticals, Inc.
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Mar 2025 (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.
Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.
Detailed description
After up to a 4-week screening period, participants will undergo 8 weeks of active or placebo treatment (Period 1), followed by an 8-week washout period, and then cross over to 8 weeks of placebo or active treatment (Period 2). Patients will be followed for 2 weeks after completion of Period 2. Two dosing groups are designated as Group A, who are randomly assigned to active treatment with KZ101 in Period 1 and saline in Period 2, and Group B, who are randomly assigned to saline infusion in Period 1 and active treatment with KZ101 in Period 2. Dosing in both periods will consist of 2 IV infusions of either saline (placebo) or KZ101 (active treatment), given 4 weeks apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug followed by Placebo | Experimental | Drug: KZ101, Drug: Placebo |
| Placebo followed by Drug | Placebo comparator | Drug: KZ101, Drug: Placebo |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Subject must meet all of the following criteria to be enrolled in this study.
- Male, aged 5-14 years
- Clinical diagnosis of ASD by DSM-5 criteria
- ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).
- CGI-S ≥ 4 for socialization specific symptoms of ASD
Key exclusion criteria (17 listed)
- Subjects who meet any of the following criteria will be excluded from the study.
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 |
|---|---|---|
| KZ101Also: Suramin, Suramin sodiumFor active treatment with KZ101, a loading dose of 454 mg/m2 (salt-free) will be followed by a treatment dose of 363 mg/m2 (salt-free). | Drug | Drug followed by Placebo, Placebo followed by Drug |
| PlaceboAlso: SalineDosing in the placebo group will consist of a volume of normal saline equivalent to that given during the active treatment period for each participant. | Drug | Drug followed by Placebo, Placebo followed by Drug |
Primary outcome
Primary Efficacy Endpoint - Vineland-3 Socialization Domain
Time frame: Change from Screening to Week 8 (before washout) will be compared to change from Week 16 to Week 24 (after washout).
The primary efficacy endpoint will be the change in standard score on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition (Vineland-3), which includes subdomains for coping skills, play skills, and interpersonal relation skills.
8 secondary outcomes
Secondary Efficacy Endpoint - Vineland-3, Additional Scores
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Global Impresssion, Severity/Change
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Social Responsiveness Scale-2
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Aberrant Behavior Checklist, Second Edition (ABC-2)
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Childhood Sleep Habits Questionnaire (CSHQ)
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Parenting Stress Impact (PSI)
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Child Behavior Check List (CBCL)
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
Secondary Efficacy Endpoint - Ohio State University Autism Rating Scale, 5th Edition
Time frame: Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).
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 30 Jul 2026.
- Background: PubMed 23516405Naviaux RK, Zolkipli Z, Wang L, Nakayama T, Naviaux JC, Le TP, Schuchbauer MA, Rogac M, Tang Q, Dugan LL, Powell SB. Antipurinergic therapy corrects the autism-like features in the poly(IC) mouse model. PLoS One. 2013;8(3):e57380. doi: 10.1371/journal.pone.0057380. Epub 2013 Mar 13.
- Background: PubMed 24937094Naviaux JC, Schuchbauer MA, Li K, Wang L, Risbrough VB, Powell SB, Naviaux RK. Reversal of autism-like behaviors and metabolism in adult mice with single-dose antipurinergic therapy. Transl Psychiatry. 2014 Jun 17;4(6):e400. doi: 10.1038/tp.2014.33.
- Background: PubMed 25705365Naviaux JC, Wang L, Li K, Bright AT, Alaynick WA, Williams KR, Powell SB, Naviaux RK. Antipurinergic therapy corrects the autism-like features in the Fragile X (Fmr1 knockout) mouse model. Mol Autism. 2015 Jan 13;6:1. doi: 10.1186/2040-2392-6-1. eCollection 2015.
- Background: PubMed 28695149Naviaux RK, Curtis B, Li K, Naviaux JC, Bright AT, Reiner GE, Westerfield M, Goh S, Alaynick WA, Wang L, Capparelli EV, Adams C, Sun J, Jain S, He F, Arellano DA, Mash LE, Chukoskie L, Lincoln A, Townsend J. Low-dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial. Ann Clin Transl Neurol. 2017 May 26;4(7):491-505. doi: 10.1002/acn3.424. eCollection 2017 Jul.
- Thompson Autism and Neurodevelopmental Center, Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this time.
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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.
Aram Kim, MD principal investigator
Thompson Autism and Neurodevelopmental Center, Children's Hospital of Orange County
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KZ101 in people with Autism Spectrum Disorder (ASD), run by Children's Hospital of Orange County at 2 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 12 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Adrienne Moore, PhD (714-288-7456, adrienne.moore@choc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint - Vineland-3 Socialization Domain (time frame: Change from Screening to Week 8 (before washout) will be compared to change from Week 16 to Week 24 (after washout).). 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 NCT06866275, which also lists 4 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 30 Jul 2026.