Clostridium Difficile InfectionPhase 2/3NCT03105479
Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
A Phase 2/3 study testing Cadazolid, Vancomycin capsule and Vancomycin solution in people with Clostridium Difficile Infection, run by Actelion at 20 sites in 9 countries.
Trial summary
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Cadazolid, Vancomycin capsule and Vancomycin solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 14 Apr 2017to 17 Apr 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure.
- Male or female from birth to < 18 years of age, diagnosed with Clostridium Difficile-associated diarrhea (CDAD).
- Females of childbearing potential must have a negative pregnancy test at screening and must agree to use an adequate and reliable method of contraception.
Who cannot join
- Positive Rotavirus test for subjects < 5 years.
- Fulminant or life-threatening CDAD.
- More than one previous episode of CDAD in the 3 month period prior to enrollment / randomization.
- Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF).
- Subjects with body weight < 3 kg.
- Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology.
Show all 11Show fewer
- Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug to prevent or treat CDAD within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrollment / randomization.
- Monoclonal antibodies against C. difficile within 6 months prior to enrollment / randomization.
- Previous vaccination against C. difficile.
- Known mental disorders.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study, or compliance with the protocol.
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
United States5 sites
University of Chicago, Dept. Of Medicine
Chicago, Illinois, 60637
Texas Children's Hospital Feigin Cente
Houston, Texas, 77030
Snake River Research, PLLC
Idaho Falls, Idaho, 83404
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71103
SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH) - Pediatric Designated AIDS Center
Syracuse, Ohio, 13210
Poland4 sites
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza
Bydgoszcz, 85-030
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem
Poznan, 61-734
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302
Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii, Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-730
Hungary2 sites
Egyesített Szent István és Szent László Kórház - Rendelőintézet / Gyermekinfektológiai Osztály
Budapest, 1097
Pándy Kálmán Megyei Kórház
Gyula, 5700
Italy2 sites
Ospedale Buzzi
Milan, 20154
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu
Roma, 00165
Romania2 sites
Institutul National De Boli Infectioase "Prof. Dr. Matei Bals", sectia IX pediatrie
Bucharest, 21105
Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi, Clinica de Boli Infectioase I,
Iași, 700116
Spain2 sites
Hospital Sant Joan de Déu, Esplugues
Barcelona, 8950
Hospital Universitario Infantil LA PAZ
Madrid, 28046
Canada1 site
Infection Prevention & Control, AGW5 Foothills Medical Center 1403 29th Street N.W.
Calgary, T2N 2T9
About this study
Official title: A Prospective, Multicenter Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Cadazolid Versus Vancomycin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.
Read the detailed description
This multicenter, study will be run into two parts. Both parts will be run in consecutive age cohorts, starting from the oldest age categories(12 to < 18 years old) to the youngest (birth to < 3 months).
- Part A is an open-label, dose finding part to be conducted in at least 24 subjects.
- Part B follows a randomized, assessor-blinded, parallel-group design with vancomycin used as an active comparator. Part B will be conducted in about 176 children.
In both parts, the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Cadazolid, Vancomycin capsule, Vancomycin solution
- Keywords
- vancomycin, children, cadazolid, clostridium difficile associated diarrhea
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadazolidDrug
Also called ACT-179811
Granules for oral suspension to be administered twice daily
Vancomycin capsuleDrug
Capsule containing 125 mg of vancomycin to be administered orally 4 times a day
Vancomycin solutionDrug
Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| Part A / Cohort A | Experimental | Subjects from 12 years to 18 years old (exclusive) will receive cadazolid 500 mg per day for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects. Receives: Drug: Cadazolid |
| Part A / Cohort B | Experimental | Subjects from 6 years to 12 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort A reviewed by the Independent Data Monitoring Committee (IDMC). Receives: Drug: Cadazolid |
| Part A / Cohort C | Experimental | Subjects from 2 years to 6 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort B reviewed by the IDMC. Receives: Drug: Cadazolid |
| Part A/ Cohort D | Experimental | Subjects from 3 months to 2 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort C reviewed by the IDMC. Receives: Drug: Cadazolid |
| Part A/ Cohort E | Experimental | Subjects from birth to 3 months old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort D reviewed by the IDMC. Receives: Drug: Cadazolid |
| Part B / Cadazolid | Experimental | Subjects from birth to 18 years old (exclusive) will receive cadazolid for 10 days, at the dose defined in the corresponding age cohort in Part A. Receives: Drug: Cadazolid |
| Part B / Vancomycin | Active comparator | Subjects from birth to 18 years old (exclusive) will receive vancomycin capsule (for subjects able to swallow) or vancomycin solution (for the others) during 10 days . Receives: Drug: Vancomycin capsule; Drug: Vancomycin solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate During Part B
This is the percentage of participants in part B reported as with a clinical cure. Clinical Cure is defined as: • <3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects < 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive). percentage of subjects with a clinical cure
Measured: Day 10 (End of Treatment) + 2 days
Maximal Plasma Concentration (Cmax) of Cadazolid During Part A
Blood samples are collected at different timepoints on Day 10 for the determination of cadazolid Cmax after 10 days of treatment.
Measured: Day 10 (End of Treatment)
Time to Reach Cmax (Tmax) of Cadazolid During Part A
Blood samples are collected at different timepoints to determine the time when the maximal plasma concentration of cadazolid is reached.
Measured: Day 10 (End of Treatment)
Area Under the Plasma Concentration Time Curve (AUC) of Cadazolid During Part A
Blood samples are collected at different timepoints for the determination of the cadazolid AUC over one dosing interval (0-12h) on Day 10.
Measured: Day 10 (End of Treatment)
Fecal Concentrations of Cadazolid During Part A
A fecal sample is collected as the end-of-treatment visit in all participants in Part A.
Measured: Day 10 (End of Treatment)
Secondary outcomes (9)
Clinical Cure Rate During Part A
This is the percentage of participants in Part A reported as with a clinical cure. Clinical Cure is defined as: • <3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects < 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive).
Measured: Day 10 (End of Treatment) + 2 days
Sustained Clinical Cure Rate During Part A and Part B
This is the percentage of participants in Parts A and B reported as with sustained clinical cure. Sustained clinical cure is defined as • Clinical Cure and no Recurrence until 30 days after the last study drug intake (end of study).
Measured: Day 40 (on average)
Recurrence Rate During Part A and Part B
This is the percentage of participants in Parts A and B assessed as having a recurrence out of subjects meeting the criteria for Clinical Cure. Recurrence is defined as: • Clinical Cure AND New episode of diarrhea with ≥ 3 UBMs (or watery diarrhea if subject < 2 years) on any day between EOT + 3 days and end of study AND • Stool test showing positive C. difficile (as defined in Inclusion Criterion 4), AND •Antimicrobial treatment active against CDAD started between EOT + 3 days and end of study.
Measured: Day 40 (on average)
Time to Recurrence in Part B
This it the time (in days) elapsed between the last dose of study drug and the onset day of new episode of diarrhea reported as Kaplan-Meier estimates (KM estimates)
Measured: Day 40 (on average)
Time to Resolution of Diarrhea in Part B
This is the time (in days) elapsed between the first dose of study treatment and the resolution of diarrhea and reported as Kaplan-Meier estimates (KM estimates). The date of resolution of Diarrhea (ROD) is defined as the date of the first day of the 2 consecutive days on treatment with < 3 UBM (or no watery diarrhea for subjects < 2 years of age). Time to ROD is the time (in days) elapsed between the first dose of study treatment and the ROD
Measured: Day 10
Adverse Events Leading to Premature Discontinuation of Study Treatment
Number of participants who prematurely discontinued the study treatment due to an adverse event
Measured: Up to Day 10
Marked Abnormalities in Clinical Laboratory Parameters
Number of participants with any marked abnormalities in laboratory parameters up to 7 days after end of treatment
Measured: Day 17 (on average)
Marked Abnormalities in Vital Signs
Number of subjects with any treatment-emergent abnormalities in vital signs (up to 7 days after end of treatment)
Measured: Day 17 (on average)
Treatment-emergent Adverse Events (TEAES)
Number of subjects with any TEAEs. A TEAE is any adverse event temporally associated with the use of study treatment (from study treatment initiation until 7 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Measured: Day 17 (on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start14 Apr 2017
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Why it stopped: Study suspended in October 2017 and terminated April 17, 2018 after decision to discontinue the study drug development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile InfectionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105479
- Sponsor's protocol ID
- AC-061A303
- Other IDs
- 2015-004805-17, 2015
- Status last verified
- Jun 2025
- First submitted
- 23 Mar 2017
- Last updated
- 8 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Cadazolid Versus Vancomycin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
- ClinicalTrials.gov ID
- NCT03105479
- Acronym / sponsor ID
- AC-061A303
- Conditions
- Clostridium Difficile Infection
- Keywords
- vancomycin, children, cadazolid, clostridium difficile associated diarrhea
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study suspended in October 2017 and terminated April 17, 2018 after decision to discontinue the study drug development
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Posted 3 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.
Detailed description
This multicenter, study will be run into two parts. Both parts will be run in consecutive age cohorts, starting from the oldest age categories(12 to < 18 years old) to the youngest (birth to < 3 months).
- Part A is an open-label, dose finding part to be conducted in at least 24 subjects.
- Part B follows a randomized, assessor-blinded, parallel-group design with vancomycin used as an active comparator. Part B will be conducted in about 176 children.
In both parts, the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A / Cohort A | Experimental | Drug: CadazolidSubjects from 12 years to 18 years old (exclusive) will receive cadazolid 500 mg per day for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects. |
| Part A / Cohort B | Experimental | Drug: CadazolidSubjects from 6 years to 12 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort A reviewed by the Independent Data Monitoring Committee (IDMC). |
| Part A / Cohort C | Experimental | Drug: CadazolidSubjects from 2 years to 6 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort B reviewed by the IDMC. |
| Part A/ Cohort D | Experimental | Drug: CadazolidSubjects from 3 months to 2 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort C reviewed by the IDMC. |
| Part A/ Cohort E | Experimental | Drug: CadazolidSubjects from birth to 3 months old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort D reviewed by the IDMC. |
| Part B / Cadazolid | Experimental | Drug: CadazolidSubjects from birth to 18 years old (exclusive) will receive cadazolid for 10 days, at the dose defined in the corresponding age cohort in Part A. |
| Part B / Vancomycin | Active comparator | Drug: Vancomycin capsule, Drug: Vancomycin solutionSubjects from birth to 18 years old (exclusive) will receive vancomycin capsule (for subjects able to swallow) or vancomycin solution (for the others) during 10 days . |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure.
- Male or female from birth to < 18 years of age, diagnosed with Clostridium Difficile-associated diarrhea (CDAD).
- Females of childbearing potential must have a negative pregnancy test at screening and must agree to use an adequate and reliable method of contraception.
Key exclusion criteria (11 listed)
- Positive Rotavirus test for subjects < 5 years.
- Fulminant or life-threatening CDAD.
- More than one previous episode of CDAD in the 3 month period prior to enrollment / randomization.
- Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF).
- Subjects with body weight < 3 kg.
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 |
|---|---|---|
| CadazolidAlso: ACT-179811Granules for oral suspension to be administered twice daily | Drug | Part A / Cohort A, Part A / Cohort B, Part A / Cohort C, Part A/ Cohort D, Part A/ Cohort E, Part B / Cadazolid |
| Vancomycin capsuleCapsule containing 125 mg of vancomycin to be administered orally 4 times a day | Drug | Part B / Vancomycin |
| Vancomycin solutionVancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day | Drug | Part B / Vancomycin |
Primary outcome
Clinical Cure Rate During Part B
Time frame: Day 10 (End of Treatment) + 2 days
This is the percentage of participants in part B reported as with a clinical cure. Clinical Cure is defined as: • <3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects < 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive). percentage of subjects with a clinical cure
Maximal Plasma Concentration (Cmax) of Cadazolid During Part A
Time frame: Day 10 (End of Treatment)
Blood samples are collected at different timepoints on Day 10 for the determination of cadazolid Cmax after 10 days of treatment.
Time to Reach Cmax (Tmax) of Cadazolid During Part A
Time frame: Day 10 (End of Treatment)
Blood samples are collected at different timepoints to determine the time when the maximal plasma concentration of cadazolid is reached.
Area Under the Plasma Concentration Time Curve (AUC) of Cadazolid During Part A
Time frame: Day 10 (End of Treatment)
Blood samples are collected at different timepoints for the determination of the cadazolid AUC over one dosing interval (0-12h) on Day 10.
Fecal Concentrations of Cadazolid During Part A
Time frame: Day 10 (End of Treatment)
A fecal sample is collected as the end-of-treatment visit in all participants in Part A.
9 secondary outcomes
Clinical Cure Rate During Part A
Time frame: Day 10 (End of Treatment) + 2 days
Sustained Clinical Cure Rate During Part A and Part B
Time frame: Day 40 (on average)
Recurrence Rate During Part A and Part B
Time frame: Day 40 (on average)
Time to Recurrence in Part B
Time frame: Day 40 (on average)
Time to Resolution of Diarrhea in Part B
Time frame: Day 10
Adverse Events Leading to Premature Discontinuation of Study Treatment
Time frame: Up to Day 10
Marked Abnormalities in Clinical Laboratory Parameters
Time frame: Day 17 (on average)
Marked Abnormalities in Vital Signs
Time frame: Day 17 (on average)
Treatment-emergent Adverse Events (TEAES)
Time frame: Day 17 (on average)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cadazolid, Vancomycin capsule and Vancomycin solution in people with Clostridium Difficile Infection, run by Actelion at 20 sites in 9 countries.
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 11 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: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Poland, Hungary, Italy, Romania and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure Rate During Part B (time frame: Day 10 (End of Treatment) + 2 days). The study lists 5 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 8 Jul 2025.