Pompe Disease (Late-onset)Phase 3NCT04138277
A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With Late-Onset Pompe Disease (LOPD)
A Phase 3 study testing AT2221 and ATB200 in people with Pompe Disease (Late-onset), run by Amicus Therapeutics at 60 sites in 23 countries.
Trial summary
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pompe Disease (Late-onset)
- What is being tested?
- AT2221 and ATB200
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 60 sitesin 23 countries
- Study dates
- 18 Dec 2019to 31 Dec 2024
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subject must have completed Study ATB200-03.
- Note: Subjects who were forced to withdraw from Study ATB200-03 for a logistical reason not related to the efficacy or safety of cipaglucosidase alfa/miglustat (eg, hospitalization for a car accident, COVID-19 pandemic, or emergency surgery) that resulted in several consecutive missed doses may have been eligible to participate in this study upon approval by the Amicus medical monitor.
Who cannot join
- Subject plans to receive gene therapy or participate in another interventional study for Pompe disease.
- Subject, if female, is pregnant or breastfeeding.
- Subject, whether male or female, is planning to conceive a child during the study.
- Subject had a hypersensitivity to any of the excipients in cipaglucosidase alfa or miglustat, or had a medical condition or any other extenuating circumstance that may have, in the opinion of the investigator or medical monitor, posed an undue safety risk to the subject or may have compromised his/her ability to comply with or adversely impacted protocol requirements.
Trial locations and contacts
60 sites in 23 countries.
60 sites in 23 countries
United States18 sites
Emory Clinic
Atlanta, Georgia, 30322
Billings Clinic
Billings, Montana, 59101
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio, 45219
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
Lysosomal and Rare Disorders Research and Treatment Center, Inc.
Fairfax, Virginia, 22030
University of Florida Clinical Research Center
Gainesville, Florida, 32610
Northwell Health
Great Neck, New York, 11021
Hackensack University Medical Center
Hackensack, New Jersey, 07061
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
University of California, Irvine
Irvine, California, 92868
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
NYU School of Medicine
New York, New York, 10017
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UPMC Montefiore Clinical and Translational Research Center
Pittsburgh, Pennsylvania, 15213
University of Utah
Salt Lake City, Utah, 84108
Washington University School of Medicine
St Louis, Missouri, 63110
France5 sites
Hôpital Pierre Wertheimer
Bron, 69577
Hôpital Raymond Poincaré
Garches, 92380
Hôpital Salengro
Lille, 59037
Hôpital de la Timone
Marseille, 13385
Hôpital Pasteur 2
Nice, 06001
Japan5 sites
Fukuoka University Hospital
Fukuoka, 814-0180
Kagoshima University Hospital
Kagashima, 890-8520
Izumi City General Hospital
Osaka, 594 0073
Hokkaido University Hospital
Sapporo, 060 8648
The Jikei University Hospital
Tokyo, 105-8471
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Brisbane & Women's Hospital
Brisbane, Queensland, 4029
Monash Medical Centre
Clayton, Victoria, 3168
Westmead Hospital
Westmead, New South Wales
United Kingdom4 sites
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Royal Free Hospital NHS Foundation Trust
London, NW3 2QG
Salford Royal NHS Foundation Trust
Salford, M6 8HD
Germany3 sites
Universitätsklinikum Bonn
Bonn, 53127
Friedrich-Baur Institut
München, 80336
Universitätsklinikum Münster
Münster, 48149
Hungary3 sites
Semmelweis University
Budapest, 1085
University of Pécs
Pécs, 7623
University of Szeged
Szeged, 6725
Canada2 sites
Alberta Children's Hospital, Heritage Medical Research Clinic
Calgary, Alberta, T3B 6A8
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Italy2 sites
UOC di Neurologia e Malattie Neuromuscolari
Messina, 98124
Universitaria Federico II
Naples, 80131
Bosnia and Herzegovina1 site
University Clinical Centre of the Republic of Srpska
Banja Luka, The Republic of Srpska, 78000
South Korea1 site
Pusan National University
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease (LOPD)
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.
Read the detailed description
This is an open-label extension study for subjects who completed the ATB200-03 study. The subjects will stay in this study until regulatory approval or marketing authorization and/or commercialization in the participating subject's country.
- Conditions
- Pompe Disease (Late-onset)
- Being tested
- AT2221, ATB200
- Keywords
- Pompe, rhGAA
- Medical subject headings
- Glycogen Storage Disease Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT2221Drug
Also called miglustat
Participants received ATB200 co-administered with AT2221 (miglustat)
ATB200Biological
Also called cipaglucosidase alfa
Enzyme Replacement Therapy via intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ATB200/AT2221 | Experimental | Participants received ATB200 (cipaglucosidase alfa) co-administered with AT2221 capsule (miglustat) Receives: Drug: AT2221; Biological: ATB200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Discontinuation of Study Drug
Number of subjects with TEAE, TESAE, and TEAE leading to discontinuation during this long-term extension study
Measured: Entire extension study (mean = 40.5 months on treatment)
Secondary outcomes (12)
Change From Baseline in 6-Minute Walk Distance (6MWD)
Motor function was measured using the 6-minute walk distance (meters)
Measured: baseline, Week 208
Change From Baseline in Sitting % Predicted Forced Vital Capacity (FVC)
Pulmonary function was measured by sitting % predicted forced vital capacity (FVC)
Measured: baseline, Week 208
Change From Baseline in Manual Muscle Testing (MMT) Lower Extremity Score
Strength was measured by manual muscle testing (MMT) using the Medical Research Council grading scale (0 to 5 points, with 5 indicating normal function). Change from baseline values >0 represent improvement.
Measured: baseline, Week 208
Change From Baseline in the Total Score for Patient-reported Outcomes Measurement Information System (PROMIS®) - Physical Function
Physical Function Short Form 20a (v2.0) consisted of 20 questions. The first 14 questions were each scored on a scale from 1 to 5 as follows: 1 = unable to do; 2 = with much difficulty; 3 = with some difficulty; 4 = with a little difficulty; 5 = without any difficulty; the next 6 questions were each scored on a scale from 1 to 5 as follows: 1 = cannot do; 2 = quite a lot; 3 = somewhat; 4 = very little; 5 = not at all. The total score was calculated by summing up scores (1 to 5) across all items. Total scores range from 20 to 100. A higher score represented a better outcome.
Measured: baseline, Week 208
Change From Baseline in the Total Score for PROMIS® - Fatigue
Fatigue Short Form 8a consisted of 6 questions, each scored on a scale from 1 to 5 as follows: 1 = not at all; 2 = a little bit; 3 = somewhat; 4 = quite a bit; 5 = very much; and 2 questions, each scored on a scale from 1 to 5 as follows: 1 = never; 2 = rarely; 3 = sometimes; 4 = often; 5 = always. The total score was calculated by summing up scores (1 to 5) across all items resulting in a total score range from 6 (minimum) to 30 (maximum). A lower score represented lower fatigue symptoms.
Measured: baseline, Week 208
Change From Baseline in Gait, Stairs, Gower, Chair (GSGC) Test
The GSGC consisted of a 10-meter walk for evaluation of gait, a 4-stair climb, Gowers' maneuver, and arising from a chair. Results of the GSGC included the time required to complete the individual tests, individual scores for each of the tests (1 to 7 points for each of gait, 4-stair climb, and Gowers' maneuver, and 1 to 6 points for arising from a chair), and a total score. GSGC total score was the sum of the component scores from the 4 functional tests. The total score ranged from a minimum of 4 points (normal performance) to a maximum of 27 points (worst performance).
Measured: baseline, Week 208
Change From Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Responses
The EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1=no problems, Level 2=slight problems, Level 3=moderate problems, Level 4=severe problems, and Level 5=extreme problems. In this categorical assessment, subjects were asked to indicate their health state by ticking the box next to the most appropriate statement in each of the 5 dimensions.
Outcomes for change from baseline at Week 208 include 'no change', 'worsening' relative to baseline category, or 'improvement' relative to baseline category. Changes (worsening or improvement) are shown by magnitude of change (how many Levels) in each categorical assessment.
Measured: baseline, Week 208
Change From Baseline in Overall Physical Well-being (Subject's Global Impression of Change [SGIC], Question 1)
The Subject's Global Impression of Change overall physical well-being (question 1) is scored on a 7-point rating scale ranging from "very much worse" to "very much improved."
Measured: baseline, Week 208
Change From Baseline in Physician's Global Impression of Change (PGIC) Overall Status
The Physician's Global Impression of Change (PGIC) is designed to record the physician's assessment of the subject's status, taking into account the subject's signs and symptoms and other neuromuscular symptoms, and signs relative to their status at the Baseline Visit. The PGIC is based on a single item that is scored on a 7-point rating scale ranging from 1 "very much worse" to 7 "very much improved."
Measured: baseline, Week 208
Percent Change From Baseline in Creatine Kinase (U/L)
Percent change from baseline to Week 208 in the levels of biomarker creatine kinase (CK)
Measured: baseline, Week 208
Percent Change From Baseline in Urine Hex4 (mmol/Mol Creatinine)
Percent change from baseline to Week 208 in the levels of biomarker urine Hex4.
Measured: baseline, Week 208
Proportion of Subjects With Positive Anti-drug Antibodies at Baseline and Week 208
Immunogenicity was assessed by the number (%) of subjects with positive specific anti-cipaglucosidase antibodies at baseline and at Week 208
Measured: baseline, Week 208
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start18 Dec 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pompe Disease (Late-onset)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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amicus Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138277
- Sponsor's protocol ID
- ATB200-07
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2019
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hopkin RJ, Byrne BJ, Dimachkie MM, Kishnani PS, Mozaffar T, Roberts M, Schoser B, van der Beek NAME, van der Ploeg AT, Wenninger S, Brudvig J, Fox B, Holdbrook F, Jain V, Johnson F, Zhang J, Parenti G. Miglustat: a first-in-class enzyme stabilizer for cipaglucosidase alfa for the treatment of late-onset Pompe disease. Ther Adv Rare Dis. 2026 Feb 26;7:26330040261425686. doi: 10.1177/26330040261425686. eCollection 2026 Jan-Dec.
PubMed 41769220Andersen H, Diaz-Manera J, Goker-Alpan O, Mozaffar T, Sitaraman Das S, Fox B, Amon F, O'Brien-Prince K, Goldman M, Holdbrook F, Jain V, Byrne BJ. Safety of home administration of cipaglucosidase alfa plus miglustat in late-onset Pompe disease: results from multiple clinical trials. Ther Adv Rare Dis. 2026 Jan 31;7:26330040261416943. doi: 10.1177/26330040261416943. eCollection 2026 Jan-Dec.
PubMed 41631150Schoser B, Kishnani PS, Bratkovic D, Byrne BJ, Claeys KG, Diaz-Manera J, Laforet P, Roberts M, Toscano A, van der Ploeg AT, Castelli J, Goldman M, Holdbrook F, Sitaraman Das S, Wasfi Y, Mozaffar T; ATB200-07 Study Group. 104-week efficacy and safety of cipaglucosidase alfa plus miglustat in adults with late-onset Pompe disease: a phase III open-label extension study (ATB200-07). J Neurol. 2024 May;271(5):2810-2823. doi: 10.1007/s00415-024-12236-0. Epub 2024 Feb 28.
PubMed 38418563
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease (LOPD)
- ClinicalTrials.gov ID
- NCT04138277
- Acronym / sponsor ID
- ATB200-07
- Conditions
- Pompe Disease (Late-onset)
- Keywords
- Pompe, rhGAA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Amicus TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Posted 12 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.
Detailed description
This is an open-label extension study for subjects who completed the ATB200-03 study. The subjects will stay in this study until regulatory approval or marketing authorization and/or commercialization in the participating subject's country.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATB200/AT2221 | Experimental | Drug: AT2221, Biological: ATB200Participants received ATB200 (cipaglucosidase alfa) co-administered with AT2221 capsule (miglustat) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Subject must have completed Study ATB200-03.
- Note: Subjects who were forced to withdraw from Study ATB200-03 for a logistical reason not related to the efficacy or safety of cipaglucosidase alfa/miglustat (eg, hospitalization for a car accident, COVID-19 pandemic, or emergency surgery) that resulted in several consecutive missed doses may have been eligible to participate in this study upon approval by the Amicus medical monitor.
Key exclusion criteria (4 listed)
- Subject plans to receive gene therapy or participate in another interventional study for Pompe disease.
- Subject, if female, is pregnant or breastfeeding.
- Subject, whether male or female, is planning to conceive a child during the study.
- Subject had a hypersensitivity to any of the excipients in cipaglucosidase alfa or miglustat, or had a medical condition or any other extenuating circumstance that may have, in the opinion of the investigator or medical monitor, posed an undue safety risk to the subject or may have compromised his/her ability to comply with or adversely impacted protocol requirements.
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 |
|---|---|---|
| AT2221Also: miglustatParticipants received ATB200 co-administered with AT2221 (miglustat) | Drug | ATB200/AT2221 |
| ATB200Also: cipaglucosidase alfaEnzyme Replacement Therapy via intravenous infusion | Biological | ATB200/AT2221 |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Discontinuation of Study Drug
Time frame: Entire extension study (mean = 40.5 months on treatment)
Number of subjects with TEAE, TESAE, and TEAE leading to discontinuation during this long-term extension study
12 secondary outcomes
Change From Baseline in 6-Minute Walk Distance (6MWD)
Time frame: baseline, Week 208
Change From Baseline in Sitting % Predicted Forced Vital Capacity (FVC)
Time frame: baseline, Week 208
Change From Baseline in Manual Muscle Testing (MMT) Lower Extremity Score
Time frame: baseline, Week 208
Change From Baseline in the Total Score for Patient-reported Outcomes Measurement Information System (PROMIS®) - Physical Function
Time frame: baseline, Week 208
Change From Baseline in the Total Score for PROMIS® - Fatigue
Time frame: baseline, Week 208
Change From Baseline in Gait, Stairs, Gower, Chair (GSGC) Test
Time frame: baseline, Week 208
Change From Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Responses
Time frame: baseline, Week 208
Change From Baseline in Overall Physical Well-being (Subject's Global Impression of Change [SGIC], Question 1)
Time frame: baseline, Week 208
Change From Baseline in Physician's Global Impression of Change (PGIC) Overall Status
Time frame: baseline, Week 208
Percent Change From Baseline in Creatine Kinase (U/L)
Time frame: baseline, Week 208
Percent Change From Baseline in Urine Hex4 (mmol/Mol Creatinine)
Time frame: baseline, Week 208
Proportion of Subjects With Positive Anti-drug Antibodies at Baseline and Week 208
Time frame: baseline, Week 208
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41769220Hopkin RJ, Byrne BJ, Dimachkie MM, Kishnani PS, Mozaffar T, Roberts M, Schoser B, van der Beek NAME, van der Ploeg AT, Wenninger S, Brudvig J, Fox B, Holdbrook F, Jain V, Johnson F, Zhang J, Parenti G. Miglustat: a first-in-class enzyme stabilizer for cipaglucosidase alfa for the treatment of late-onset Pompe disease. Ther Adv Rare Dis. 2026 Feb 26;7:26330040261425686. doi: 10.1177/26330040261425686. eCollection 2026 Jan-Dec.
- Derived from this study: PubMed 41631150Andersen H, Diaz-Manera J, Goker-Alpan O, Mozaffar T, Sitaraman Das S, Fox B, Amon F, O'Brien-Prince K, Goldman M, Holdbrook F, Jain V, Byrne BJ. Safety of home administration of cipaglucosidase alfa plus miglustat in late-onset Pompe disease: results from multiple clinical trials. Ther Adv Rare Dis. 2026 Jan 31;7:26330040261416943. doi: 10.1177/26330040261416943. eCollection 2026 Jan-Dec.
- Derived from this study: PubMed 38418563Schoser B, Kishnani PS, Bratkovic D, Byrne BJ, Claeys KG, Diaz-Manera J, Laforet P, Roberts M, Toscano A, van der Ploeg AT, Castelli J, Goldman M, Holdbrook F, Sitaraman Das S, Wasfi Y, Mozaffar T; ATB200-07 Study Group. 104-week efficacy and safety of cipaglucosidase alfa plus miglustat in adults with late-onset Pompe disease: a phase III open-label extension study (ATB200-07). J Neurol. 2024 May;271(5):2810-2823. doi: 10.1007/s00415-024-12236-0. Epub 2024 Feb 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AT2221 and ATB200 in people with Pompe Disease (Late-onset), run by Amicus Therapeutics at 60 sites in 23 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, France, Japan, Australia, United Kingdom and 18 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 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?
Yes. Results are posted in the registry (first posted 12 Jan 2026). 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?
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Discontinuation of Study Drug (time frame: Entire extension study (mean = 40.5 months on treatment)). 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 NCT04138277, which also lists 3 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 5 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.