Fabry DiseasePhase 3NCT04020055
A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease
A Phase 3 study testing migalastat HCl 150 mg in people with Fabry Disease, run by Amicus Therapeutics at 12 sites in 6 countries.
Trial summary
An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fabry Disease
- What is being tested?
- migalastat HCl 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 31 Oct 2022to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or older, diagnosed with Fabry disease.
- Subject (or legally authorized representative as applicable) is willing and able to provide written informed consent and authorization for use and disclosure of Personal Health Information
- Subject has a GLA variant that is amenable to migalastat recorded in their medical records
- Subject has at least 1 documented eGFR value of < 30 mL/min/1.73 m2 within the last 3 months and has an eGFRMDRD value of < 30 mL/min/1.73 m2 at Visit 1
- Subjects with ESRD have been on a stable 2- or 3-times a week HD (standard or HDF) regimen for at least 2 months prior to the screening visit
- Subjects with ESRD must commit to completing at least 4 standard HD or HDF sessions during each 2-week dosing interval.
- Subjects with ESRD must commit to completing the entire prescribed duration for each dialysis session.
- If of reproductive potential, both male and female patients agree to use a medically accepted method of contraception
Who cannot join
- Subject has undergone kidney transplantation
- Subject is on peritoneal dialysis
- Subject is treated or has been treated with another investigational drug (except migalastat) within the 30 days
- Subject has undergone any gene therapy at any time prior to the study or anticipates undergoing gene therapy during the study.
- Subject has had a documented transient ischemic attack, stroke, unstable angina, or myocardial infarction
- Subject has clinically significant unstable cardiac disease
Show all 13Show fewer
- Subject has any intercurrent illness or condition that may preclude the subject from fulfilling the protocol requirements
- Subject has a history of allergy or sensitivity to migalastat (including excipients) or other iminosugars (eg, miglustat, miglitol)
- Subject requires concurrent treatment with Glyset® (miglitol), Replagal® (agalsidase alfa), or Fabrazyme® (agalsidase beta)
- Subject requires concurrent treatment with Zavesca® (miglustat) or has been treated with Zavesca
- Female subject is pregnant or breast-feeding
- Subject is unable to comply with study requirements
- In France only, protected persons as defined by the Public Health Code
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United States3 sites
Emory University
Atlanta, Georgia, 30322
The Cleveland Clinic
Cleveland, Ohio, 44195
Lysosomal and Rare Disorders Research and Treatment Center, Inc
Fairfax, Virginia, 22030
Spain3 sites
Hospital Universitari(o) de Bellvitge (HUB) Feixa Llarga
Barcelona, 08907
Hospital General Universitario de Elda
Elda, 03600
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Australia2 sites
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal Perth Hospital
Perth, Washington, 6000
Japan2 sites
Shizuoka General Hospital
Shizuoka, Shizuoka, 420-8527
Osaka University Hospital
Suita, Osaka, 565-0871
Portugal1 site
Centro Hospitalar e Universitário de Coimbra (CHUC)
Coimbra, 3041-801
About this study
Official title: An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects With Fabry Disease and Amenable GLA Variants and Severe Renal Impairment or End-Stage Renal Disease Treated With Hemodialysis
An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)
Read the detailed description
This is an open-label, non-comparative study for subjects with Fabry disease who have an estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease equation (eGFRMDRD) value of < 30 mL/min/1.73 m2. Subjects may have had previous exposure to migalastat, either commercially or as a participant in a previous migalastat study.
Two distinct populations of subjects with Fabry disease and renal impairment will be enrolled into this study:
- Cohort 1: Subjects with SRI not receiving any type of dialysis treatment
- Cohort 2: ESRD subjects who are receiving hemodialysis treatment, either standard hemodialysis (HD) or hemodiafiltration (HDF). Only subjects who can receive HD/HDF at the study clinic or at an affiliated center where the Investigator already has oversight should be enrolled into Cohort 2.
Subjects entering into this study will undergo screening (Visit 1) to confirm enrollment eligibility including confirmatory GLA genotyping. Subjects who meet eligibility criteria will have a Baseline Visit (Visit 2) within 30 days of screening. Subjects who do not meet eligibility criteria (eg, subjects with an eGFR > 30 mL/min/1.73 m2) may be re-screened.
- Conditions
- Fabry Disease
- Being tested
- migalastat HCl 150 mg
- Keywords
- Renal Disease, Severe Renal Impairment (SRI), End-Stage Renal Disease (ESRD)
- Medical subject headings
- Fabry Disease, Kidney Diseases, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
migalastat HCl 150 mgDrug
Also called migalastat, AT1001
migalastat HCl 150 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | All subjects will receive migalastat 123 mg, equivalent to 150 mg migalastat HCl (hereafter, migalastat) at a dose regimen based on their eGFRMDRD result at Visit 1. Subjects will take 1 migalastat capsule orally with water either every 4 or 7 days. |
| Cohort 2: End-Stage Renal Disease | Experimental | All hemodialysis subjects will receive migalastat 123 mg, equivalent to 150 mg migalastat HCl (hereafter, migalastat). Subjects will take 1 migalastat capsule orally with water every other week. Receives: Drug: migalastat HCl 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Time to maximum concentration (tmax)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Apparent terminal elimination half-life (t½)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK
Measured: Baseline through Month 12
Concentration at the end of a dosing interval at steady state (Ctrough)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Average plasma migalastat concentration over the dosing interval (Cavg)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Area under the concentration-time curve at steady state during the dosing interval (AUC0-τ)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Area under the concentration-time curve from zero time (pre-dose) extrapolated to infinite time (AUC0-∞)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Apparent plasma clearance (CL/F)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK
Measured: Baseline through Month 12
Apparent terminal phase volume of distribution (Vz/F)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Dialysis clearance (CLD)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Volume of dialysate collected during the interval (VD)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Mean migalastat concentration in dialysate (CD)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Amount recovered in dialysate (AeD)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Fraction of the dose recovered in dialysate (FeD)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Mean migalastat plasma concentration during the dialysis interval (P)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Mean inlet area under the curve (AUCinlet)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Mean outlet area under the curve (AUCoutlet)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Extraction ratio (ED)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Dialyzer blood flow (QD)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Cumulative amount excreted over all collection intervals (Ae0-τ)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Fraction of the dose recovered after the last measurable time point postdose (Fe0-τ)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Renal clearance (CLr)
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Measured: Baseline through Month 12
Secondary outcomes (4)
Adverse events (AEs)
To assess the safety and tolerability of migalastat in Fabry subjects with severe renal impairment and end stage renal disease.
Measured: Baseline through Month 12
Change from baseline in estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease equation (eGFR MDRD)
To assess the safety and tolerability of migalastat in Fabry subjects with severe renal impairment and end stage renal disease
Measured: Baseline through Month 12
Change from baseline eGFR based on the Chronic Kidney Disease Epidemiology Collaboration equation (eGFRCKD-EPI)
To assess the safety and tolerability of migalastat in Fabry subjects with severe renal impairment and end stage renal disease
Measured: Baseline through Month 12
Change from baseline in plasma globotriaosylsphingosine (lyso-Gb3)
To evaluate the pharmacodynamics (PD) of migalastat in subjects with Fabry disease and severe renal impairment
Measured: Baseline through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start31 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fabry DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amicus Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Research, Study director, Amicus Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020055
- Sponsor's protocol ID
- AT1001-025
- Status last verified
- Oct 2025
- First submitted
- 24 Jun 2019
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects With Fabry Disease and Amenable GLA Variants and Severe Renal Impairment or End-Stage Renal Disease Treated With Hemodialysis
- ClinicalTrials.gov ID
- NCT04020055
- Acronym / sponsor ID
- AT1001-025
- Conditions
- Fabry Disease
- Keywords
- Renal Disease, Severe Renal Impairment (SRI), End-Stage Renal Disease (ESRD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Amicus TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2019 (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.
An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)
Detailed description
This is an open-label, non-comparative study for subjects with Fabry disease who have an estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease equation (eGFRMDRD) value of < 30 mL/min/1.73 m2. Subjects may have had previous exposure to migalastat, either commercially or as a participant in a previous migalastat study.
Two distinct populations of subjects with Fabry disease and renal impairment will be enrolled into this study:
- Cohort 1: Subjects with SRI not receiving any type of dialysis treatment
- Cohort 2: ESRD subjects who are receiving hemodialysis treatment, either standard hemodialysis (HD) or hemodiafiltration (HDF). Only subjects who can receive HD/HDF at the study clinic or at an affiliated center where the Investigator already has oversight should be enrolled into Cohort 2.
Subjects entering into this study will undergo screening (Visit 1) to confirm enrollment eligibility including confirmatory GLA genotyping. Subjects who meet eligibility criteria will have a Baseline Visit (Visit 2) within 30 days of screening. Subjects who do not meet eligibility criteria (eg, subjects with an eGFR > 30 mL/min/1.73 m2) may be re-screened.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | –All subjects will receive migalastat 123 mg, equivalent to 150 mg migalastat HCl (hereafter, migalastat) at a dose regimen based on their eGFRMDRD result at Visit 1. Subjects will take 1 migalastat capsule orally with water either every 4 or 7 days. |
| Cohort 2: End-Stage Renal Disease | Experimental | Drug: migalastat HCl 150 mgAll hemodialysis subjects will receive migalastat 123 mg, equivalent to 150 mg migalastat HCl (hereafter, migalastat). Subjects will take 1 migalastat capsule orally with water every other week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged 18 years or older, diagnosed with Fabry disease.
- Subject (or legally authorized representative as applicable) is willing and able to provide written informed consent and authorization for use and disclosure of Personal Health Information
- Subject has a GLA variant that is amenable to migalastat recorded in their medical records
- Subject has at least 1 documented eGFR value of < 30 mL/min/1.73 m2 within the last 3 months and has an eGFRMDRD value of < 30 mL/min/1.73 m2 at Visit 1
- Subjects with ESRD have been on a stable 2- or 3-times a week HD (standard or HDF) regimen for at least 2 months prior to the screening visit
Key exclusion criteria (13 listed)
- Subject has undergone kidney transplantation
- Subject is on peritoneal dialysis
- Subject is treated or has been treated with another investigational drug (except migalastat) within the 30 days
- Subject has undergone any gene therapy at any time prior to the study or anticipates undergoing gene therapy during the study.
- Subject has had a documented transient ischemic attack, stroke, unstable angina, or myocardial infarction
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 |
|---|---|---|
| migalastat HCl 150 mgAlso: migalastat, AT1001migalastat HCl 150 mg capsule | Drug | Cohort 2: End-Stage Renal Disease |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Time to maximum concentration (tmax)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Apparent terminal elimination half-life (t½)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK
Concentration at the end of a dosing interval at steady state (Ctrough)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Average plasma migalastat concentration over the dosing interval (Cavg)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Area under the concentration-time curve at steady state during the dosing interval (AUC0-τ)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Area under the concentration-time curve from zero time (pre-dose) extrapolated to infinite time (AUC0-∞)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Apparent plasma clearance (CL/F)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK
Apparent terminal phase volume of distribution (Vz/F)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Dialysis clearance (CLD)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Volume of dialysate collected during the interval (VD)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Mean migalastat concentration in dialysate (CD)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Amount recovered in dialysate (AeD)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Fraction of the dose recovered in dialysate (FeD)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Mean migalastat plasma concentration during the dialysis interval (P)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Mean inlet area under the curve (AUCinlet)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Mean outlet area under the curve (AUCoutlet)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Extraction ratio (ED)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Dialyzer blood flow (QD)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Cumulative amount excreted over all collection intervals (Ae0-τ)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Fraction of the dose recovered after the last measurable time point postdose (Fe0-τ)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
Renal clearance (CLr)
Time frame: Baseline through Month 12
To characterize the pharmacokinetics (PK) of migalastat and validate the population PK (popPK) model and simulations.
4 secondary outcomes
Adverse events (AEs)
Time frame: Baseline through Month 12
Change from baseline in estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease equation (eGFR MDRD)
Time frame: Baseline through Month 12
Change from baseline eGFR based on the Chronic Kidney Disease Epidemiology Collaboration equation (eGFRCKD-EPI)
Time frame: Baseline through Month 12
Change from baseline in plasma globotriaosylsphingosine (lyso-Gb3)
Time frame: Baseline through Month 12
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 6 Jul 2026.
- 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. This study is not recruiting at the moment.
Clinical Research study director
Amicus Therapeutics
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing migalastat HCl 150 mg in people with Fabry Disease, run by Amicus Therapeutics at 12 sites in 6 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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 6 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 12 sites in United States, Spain, Australia, Japan, Portugal and 1 more country. 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 phase mean?
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?
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?
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?
Maximum observed concentration (Cmax) (time frame: Baseline through Month 12). The study lists 22 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 6 Jul 2026.