Idiopathic Pulmonary FibrosisPhase 1/2NCT02257177
RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
A Phase 1/2 study testing Inhaled TD139 in people with Idiopathic Pulmonary Fibrosis, run by Galecto Biotech AB at 5 sites in United Kingdom.
Trial summary
This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Inhaled TD139
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Sep 2014to Dec 2016
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- A clinically significant illness or surgery within 8 weeks prior to the Day 1 dose of study medication.
- Significant medical history that, in the Investigator's opinion, may have adversely affected participation.
- History of allergy or significant adverse reaction to drugs similar to the investigational drug, to nicotine, or to cholinergic drugs or to any drugs with a similar chemical structure.
- History of hypersensitivity (anaphylaxis, angioedema) to any drug.
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to the Day 1 dose of study medication.
- Use of medications known to prolong QT/QTc interval within 14 days prior to the Day 1 dose of study medication.
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- Any clinically significant findings of physical examination or laboratory findings at screening.
- A clinically significant history of drug or alcohol abuse.
- Receipt of regular/over the counter medication within 14 days of the Day 1 dose of study medication that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Donation of 450 mL or more blood within the previous 3 months.
- Confirmed at Baseline / Prior to First Dose:
- Development of any exclusion criteria since screening.
- Receipt of any medication since screening that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
- Part 2 Inclusion Criteria
- Male patient or female patient of non childbearing potential with IPF.
- Male patient willing to use a condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse was in line with the preferred and usual lifestyle of the patient) from the first dose until at least 3 months after receiving the last dose of IMP.
- Aged between 45 and 85 years of age.
- With a forced vital capacity (FVC) ≥ 45% predicted and forced expiratory volume in 1 second (FEV1)/FVC ratio ≥ 0.7.
- Oxygen saturation > 90% by pulse oximetry while breathing ambient air at rest.
- Diffusing capacity of lungs for carbon monoxide (DLCO) > 25%.
- Had adequate organ function and a clinical diagnosis consistent with IPF prior to screening (based on the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Association (ATS/ERS/JRS/ALAT) consensus criteria. The diagnosis would ordinarily have been confirmed at a multidisciplinary team meeting where the high resolution computed tomography (HRCT) findings in particular would have been discussed with a radiologist with respiratory expertise.
- Able to undergo BAL.
- Provided written informed consent to participate in the study.
- Available to complete the study (including all follow up visits).
- Negative urinary drugs of abuse screen, determined within 28 days of the first dose of IMP (N.B. a positive alcohol result could have been repeated at the discretion of the Investigator).
- Negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
- No clinically significant abnormalities in 12 lead ECG determined within 28 days of the first dose of IMP.
- Confirmed at Baseline / Prior to First Dose:
- Patient continued to meet all screening inclusion criteria. Exclusion Criteria
- Any condition that made the patient at unacceptable risk for bronchoscopy.
- Active cigarette smoking (defined as smoking more than 3 cigarettes daily within the last 6 months).
- Presence of a significant co morbidity felt to limit life expectancy to less than 12 months.
- HRCT pattern showing emphysema more than the extent of fibrosis of the lung area conducted within 12 months of first dose.
- Evidence of renal, hepatic, central nervous system, or metabolic dysfunction.
- Evidence of poorly controlled diabetes mellitus (defined as a glycosylated haemoglobin (HbA1c) of > 59 mmol/mol (7.5%).
- Use of systemic immunosuppressants within 30 days of dosing.
- Currently receiving oral steroids, cytotoxic drugs (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), antifibrotic drugs (e.g., pirfenidone), vasodilator therapies for pulmonary hypertension (e.g., bosentan), unapproved (e.g., interferon gamma (INF γ), penicillamine, cyclosporine, mycophenolate) and/or investigational therapies for IPF or administration of such therapies within 4 weeks of initial screening. A current inhaled steroid dose of ≤ 1000 µg beclomethasone dipropionate equivalent per day was acceptable if the dose was anticipated to remain stable during the study.
- History of malignancy, including carcinoma during the preceding 5 years.
- History of, or current asthma.
- Participation in a clinical study of an unlicensed drug in the previous 4 months, or a marketed drug study within the previous 3 months. (N.B. washout period between studies defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Females of child bearing potential and/or with a positive pregnancy test at the screening visit.
- Confirmed at Baseline / Prior to First Dose:
- Development of any exclusion criteria since the screening visit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Edinburgh University Hospital
Edinburgh, Scotland, EH16 4SA
Royal Devon & Exeter Foundation NHS Trust
Exeter, Devon, EX2 5DW
Royal Brompton Hospital
London, SW3 6NP
Simbec Research Limited
Merthyr Tydfil, Wales, CF48 4DR
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, Tyne and Wear, NE3 3HD
About this study
Official title: A Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)
This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2 will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male subjects and female subjects of non child-bearing potential with IPF.
Read the detailed description
Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an ascending dose fashion.
A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on pre-clinical efficacy and safety data.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Inhaled TD139, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled TD139Drug
Also called TD139
DPI Galectin-3 inhibitor
PlaceboDrug
Also called inhaled placebo
DPI placebo
| Study group | Role | What they receive |
|---|---|---|
| 0.15 mg TD139 (Part 1) | Active comparator | 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Receives: Drug: Inhaled TD139 |
| 1.5 mg TD139 (Part 1) | Active comparator | 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Receives: Drug: Inhaled TD139 |
| 3 mg TD139 (Part 1) | Active comparator | 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Receives: Drug: Inhaled TD139 |
| 10 mg TD139 Part 1 | Active comparator | 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Receives: Drug: Inhaled TD139 |
| 20 mg TD139 Part 1 | Active comparator | 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Receives: Drug: Inhaled TD139 |
| 50 mg TD139 Part 1 | Active comparator | 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Receives: Drug: Inhaled TD139 |
| Placebo Part 1 | Placebo comparator | 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Receives: Drug: Placebo |
| 0.3 mg TD139 Part 2 | Active comparator | 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder. Receives: Drug: Inhaled TD139 |
| 3 mg TD139 Part 2 | Active comparator | 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder. Receives: Drug: Inhaled TD139 |
| 10 mg TD139 Part 2 | Active comparator | 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder. Receives: Drug: Inhaled TD139 |
| Placebo Part 2 | Placebo comparator | 9 Patients with IPF are administered placebo inhaled as a dry powder. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.
Measured: 0 - 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galecto Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toby Maher, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257177
- Sponsor's protocol ID
- GB-HV-01
- Status last verified
- Mar 2021
- First submitted
- 29 Sep 2014
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Interim data from the patient trial will be presented at ICLAF, Dublin 2016
Publications
Hirani N, MacKinnon AC, Nicol L, Ford P, Schambye H, Pedersen A, Nilsson UJ, Leffler H, Sethi T, Tantawi S, Gravelle L, Slack RJ, Mills R, Karmakar U, Humphries D, Zetterberg F, Keeling L, Paul L, Molyneaux PL, Li F, Funston W, Forrest IA, Simpson AJ, Gibbons MA, Maher TM. Target inhibition of galectin-3 by inhaled TD139 in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2021 May 27;57(5):2002559. doi: 10.1183/13993003.02559-2020. Print 2021 May.
PubMed 33214209
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02257177
- Acronym / sponsor ID
- GB-HV-01
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Galecto Biotech ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2 will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male subjects and female subjects of non child-bearing potential with IPF.
Detailed description
Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an ascending dose fashion.
A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on pre-clinical efficacy and safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 0.15 mg TD139 (Part 1) | Active comparator | Drug: Inhaled TD1394 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 1.5 mg TD139 (Part 1) | Active comparator | Drug: Inhaled TD1394 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 3 mg TD139 (Part 1) | Active comparator | Drug: Inhaled TD1394 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 10 mg TD139 Part 1 | Active comparator | Drug: Inhaled TD1394 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 20 mg TD139 Part 1 | Active comparator | Drug: Inhaled TD1394 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 50 mg TD139 Part 1 | Active comparator | Drug: Inhaled TD1394 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| Placebo Part 1 | Placebo comparator | Drug: Placebo12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. |
| 0.3 mg TD139 Part 2 | Active comparator | Drug: Inhaled TD1395 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder. |
| 3 mg TD139 Part 2 | Active comparator | Drug: Inhaled TD1395 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder. |
| 10 mg TD139 Part 2 | Active comparator | Drug: Inhaled TD1395 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder. |
| Placebo Part 2 | Placebo comparator | Drug: Placebo9 Patients with IPF are administered placebo inhaled as a dry powder. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (46 listed)
- A clinically significant illness or surgery within 8 weeks prior to the Day 1 dose of study medication.
- Significant medical history that, in the Investigator's opinion, may have adversely affected participation.
- History of allergy or significant adverse reaction to drugs similar to the investigational drug, to nicotine, or to cholinergic drugs or to any drugs with a similar chemical structure.
- History of hypersensitivity (anaphylaxis, angioedema) to any drug.
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to the Day 1 dose of study medication.
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 |
|---|---|---|
| Inhaled TD139Also: TD139DPI Galectin-3 inhibitor | Drug | 0.15 mg TD139 (Part 1), 0.3 mg TD139 Part 2, 1.5 mg TD139 (Part 1), 10 mg TD139 Part 1, 10 mg TD139 Part 2, 20 mg TD139 Part 1, 3 mg TD139 (Part 1), 3 mg TD139 Part 2, 50 mg TD139 Part 1 |
| PlaceboAlso: inhaled placeboDPI placebo | Drug | Placebo Part 1, Placebo Part 2 |
Primary outcome
Number of Participants With Adverse Events
Time frame: 0 - 30 days
Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33214209Hirani N, MacKinnon AC, Nicol L, Ford P, Schambye H, Pedersen A, Nilsson UJ, Leffler H, Sethi T, Tantawi S, Gravelle L, Slack RJ, Mills R, Karmakar U, Humphries D, Zetterberg F, Keeling L, Paul L, Molyneaux PL, Li F, Funston W, Forrest IA, Simpson AJ, Gibbons MA, Maher TM. Target inhibition of galectin-3 by inhaled TD139 in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2021 May 27;57(5):2002559. doi: 10.1183/13993003.02559-2020. Print 2021 May.
- Individual participant dataSharing planned: Yes. Interim data from the patient trial will be presented at ICLAF, Dublin 2016
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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.
Toby Maher, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inhaled TD139 in people with Idiopathic Pulmonary Fibrosis, run by Galecto Biotech AB at 5 sites in United Kingdom.
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 0 inclusion and 46 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 8 Apr 2021). 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?
Number of Participants With Adverse Events (time frame: 0 - 30 days). 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 NCT02257177, which also lists 1 linked publication.
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 7 Nov 2023.