Acute Pancreatitis Drug-InducedMAP-1NCT05279079
Markers in Acute Pancreatitis-1
An observational study of Acute Pancreatitis Drug-Induced, run by University of Liverpool at 4 sites in 3 countries.
Trial summary
Prospective, multi-national, multi-centre observational diagnostic study of novel microRNA and protein biomarkers in peripheral blood and/or urine to detect and predict the severity of drug-associated acute pancreatitis (AP), with comparison of the same biomarkers in patients with acute pancreatitis from other causes… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis Drug-Induced
- What is being tested?
- Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis
- Type of treatment
- Pill or oral medicine
- How many people
- 175 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 25 Jan 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult participants aged 18 years or more, comprised of 6 Groups: Group 1: Drug-associated AP Group 2: Other cause AP Group 3: Chronic pancreatitis Group 4: Pancreas Cancer Group 5: Diabetes mellitus Grouip 6: Healthy volunteers
Who may be able to join
- Drug-associated AP: patients ≥18 years old undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP and admitted to recruiting hospitals with a diagnosis of AP established by two of: (i) typical continuous upper abdominal pain (in this study for up to 2 days in duration prior to admission); (ii) amylase and/or lipase 3 or more times the upper limit of normal; (iii) characteristic findings on abdominal imaging (if undertaken urgently by computerised tomography scan (CT) or magnetic resonance imaging (MRI); and who undergo their first study blood sampling within 24 hours of admission to hospital.
- Other cause AP: patients ≥18 years old not undergoing drug treatment that has a defined risk of AP and admitted to recruiting hospitals with a diagnosis of AP established by two of: (i) typical continuous upper abdominal pain (in this study for up to 2 days in duration prior to admission); (ii) amylase and/or lipase 3 or more times the upper limit of normal; (iii) characteristic findings on abdominal imaging (if undertaken urgently by CT or MRI) and undergo their first study blood sampling within 24 hours of hospital admission.
- Chronic pancreatitis: patients with symptomatic chronic pancreatitis and diagnostic abnormalities identified by CT and/or MRI and who undergo study blood sampling as an outpatient.
- Pancreatic cancer: patients presenting with biopsy-proven or presumed pancreatic cancer and who undergo study blood sampling as an outpatient; in patients with a presumptive diagnosis of pancreatic cancer, blood and urine samples will be analysed after histological confirmation.
- Diabetes mellitus: adult patients with type 1 or type 2 diabetes mellitus treated with insulin and/or oral anti-hyperglycaemic medication for at least 3 months and ongoing and who undergo study blood sampling as an outpatient.
- Healthy volunteers: normal, healthy individuals aged ≥18 years old without evidence of systemic disease who have required no hospital intervention within the last year and received no drug treatment within the last 3 months and are severe acute respiratory distress syndrome corona virus 2 (SARS-CoV-2) negative.
Who cannot join
- Drug-associated AP: onset of continuous abdominal pain more than 2 days prior to admission to hospital; known previous AP within the last 3 months; known chronic pancreatitis; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; known prior type 1 or type 2 diabetes mellitus. Patients will not be excluded if they are undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP and an alternative cause for AP is identified (including after recruitment and blood sampling).
- Other cause AP: undergoing drug treatment that has a defined risk of AP (such patients should be considered for recruitment into Group 2); onset of continuous abdominal pain more than 2 days prior to admission to hospital; known previous AP within the last 3 months; known chronic pancreatitis; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; type 1 or type 2 diabetes mellitus.
- Chronic pancreatitis: hospital admission with AP within the last three months; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; type 1 or type 2 diabetes mellitus.
- Pancreatic cancer: hospital admission with AP within the last 3 months; known chronic pancreatitis; previous necrosectomy or pancreatic surgery and/or chemotherapy prior to sampling; type 1 or type 2 diabetes mellitus.
- Diabetes mellitus: hospital admission with AP within the last 3 months; known type 3c diabetes mellitus; known history of acute or chronic pancreatitis; known history of cystic fibrosis, known history of pancreatic or hepatobiliary malignancy; known history of necrosectomy or pancreatic surgery; gestational diabetes mellitus; monogenic diabetes mellitus syndromes; post-transplantation diabetes mellitus; diabetes mellitus attributed to drugs or toxins.
- Healthy volunteers: abnormal physical examination, abnormal routine haematology, urea, electrolytes and/or liver function tests; evidence of systemic disease; solid or haematological neoplasia within the last 5 years; hospital intervention within last 12 months; scheduled drug treatment within last 3 months and/or as required drug treatment within the last 4 weeks; infection or other sources of acute inflammation within the last 3 months.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP
Aintree University Hospital
Liverpool, Merseyside, L9 7AL
About this study
Official title: International Prospective Evaluation of Novel Biomarkers to Detect and Predict the Severity of Drug- Associated Acute Pancreatitis in Adults
Prospective, multi-national, multi-centre observational diagnostic study of novel microRNA and protein biomarkers in peripheral blood and/or urine to detect and predict the severity of drug-associated acute pancreatitis (AP), with comparison of the same biomarkers in patients with acute pancreatitis from other causes, chronic pancreatitis, pancreatic cancer, diabetes mellitus and healthy volunteers.
Read the detailed description
The MAP-1 study is designed to validate microRNA and/or pancreatic digestive enzyme biomarkers for the detection and severity assessment of drug-associated AP, for application to the assessment of adverse reactions to drugs in development or drugs already developed for other indications. The study will also assess the clinical utility of these biomarkers in AP from other causes, but is not designed to determine whether the biomarkers could be used in place of amylase and/or lipase in the standard clinical diagnosis of AP or to distinguish between the many differential diagnoses of AP. Selection is in progress of the microRNAs and pancreatic digestive enzyme biomarkers to be validated in this study, this selection being made from prospectively biobank samples obtained in a separate observational study that has separate ethical approval.
The pre-selected microRNAs and pancreatic digestive enzymes will be measured in the blood and urine of patients on admission to hospital with drug-associated acute pancreatitis (Group 1, 75 participants in receipt of one or more drugs on a defined list of drugs associated with acute pancreatitis) or other cause acute pancreatitis (Group 2, 250 participants not in receipt of any of the defined drugs). The same biomarkers will also be measured in blood and urine samples from contrast groups of patients with chronic pancreatitis (Group 3, 25 participants), pancreas cancer (Group 4, 25 participants), type I or II diabetes mellitus (Group 5, 25 participants) and healthy volunteers (Group 6, 100 participants). All participants will be at least 18 years old. MicroRNAs will be measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) and pancreatic enzymes by mass spectrometry.
- Conditions
- Acute Pancreatitis Drug-Induced
- Being tested
- Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisDiagnostic test
Panel of microRNA and pancreatic enzyme biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Drug-associated AP: patients aged 18 or more years undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP Receives: Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis | |
| Group 2 | Other cause AP: patients aged 18 or more years not undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP Receives: Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis | |
| Group 3 | Chronic pancreatitis: patients aged 18 or more years with symptomatic chronic pancreatitis confirmed by CT or MRI Receives: Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis | |
| Group 4 | Pancreas cancer: patients aged 18 or more years with biopsy proven pancreas cancer Receives: Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis | |
| Group 5 | Diabetes mellitus: patients aged 18 or more years with type 1 or type 2 diabetes mellitus in receipt of insulin or oral hypoglycaemics Receives: Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis | |
| Group 6 | Healthy volunteers Receives: Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA panel
Scale of change from normal (healthy volunteer values) of a panel of microRNAs measured in blood and urine samples from patients with mild, moderate or severe drug-associated AP during the first 24 hours of admission, confirming specificity by comparison with results from patients with other pancreatic diseases
Measured: Day of admission
Secondary outcomes (5)
Pancreatic enzyme biomarker
Scale of change from normal (healthy volunteer values) of a selected pancreatic enzyme biomarker in blood and/or urine taken from patients with mild, moderate or severe drug-associated AP during the first 24 hours of admission, confirming specificity by comparison with results from patients with other pancreatic diseases
Measured: Day of admission
MicroRNA panel
Scale of change of circulating microRNAs measured in blood samples on Day 4 (+/- 1 day) and Day 14 (+/- 2 days) after admission to assess progression of AP
Measured: Days 4 and 14 after admission
Severity of AP
Determination of AP severity will be made according to the Revised Atlanta Classification
Measured: Within 90 days of admission
Patient reported outcome
Application of the PAtieNt-rePoRted OutcoMe scale in acute pancreatItis - an international proSpEctive cohort study (PAN-PROMISE) scale
Measured: Days 4 and 14
Progress of MAP-1
Progress of recruitment of patients into MAP-1
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start25 Jan 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis Drug-InducedStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicines Initiative, TransBioLine Consortium, Liverpool University Hospitals NHS Foundation Trust, LMU Klinikum, Hospital Regional de Malaga
- Responsible party
- Sponsor
- Investigators
- Robert Sutton, MD FRCS PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279079
- Sponsor's protocol ID
- UoL001572
- Acronym
- MAP-1
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Evaluation of Novel Biomarkers to Detect and Predict the Severity of Drug- Associated Acute Pancreatitis in Adults
- ClinicalTrials.gov ID
- NCT05279079
- Acronym / sponsor ID
- MAP-1 / UoL001572
- Conditions
- Acute Pancreatitis Drug-Induced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Innovative Medicines Initiative, TransBioLine Consortium, Liverpool University Hospitals NHS Foundation Trust, LMU Klinikum, Hospital Regional de Malaga
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 15 Mar 2022 (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.
Prospective, multi-national, multi-centre observational diagnostic study of novel microRNA and protein biomarkers in peripheral blood and/or urine to detect and predict the severity of drug-associated acute pancreatitis (AP), with comparison of the same biomarkers in patients with acute pancreatitis from other causes, chronic pancreatitis, pancreatic cancer, diabetes mellitus and healthy volunteers.
Detailed description
The MAP-1 study is designed to validate microRNA and/or pancreatic digestive enzyme biomarkers for the detection and severity assessment of drug-associated AP, for application to the assessment of adverse reactions to drugs in development or drugs already developed for other indications. The study will also assess the clinical utility of these biomarkers in AP from other causes, but is not designed to determine whether the biomarkers could be used in place of amylase and/or lipase in the standard clinical diagnosis of AP or to distinguish between the many differential diagnoses of AP. Selection is in progress of the microRNAs and pancreatic digestive enzyme biomarkers to be validated in this study, this selection being made from prospectively biobank samples obtained in a separate observational study that has separate ethical approval.
The pre-selected microRNAs and pancreatic digestive enzymes will be measured in the blood and urine of patients on admission to hospital with drug-associated acute pancreatitis (Group 1, 75 participants in receipt of one or more drugs on a defined list of drugs associated with acute pancreatitis) or other cause acute pancreatitis (Group 2, 250 participants not in receipt of any of the defined drugs). The same biomarkers will also be measured in blood and urine samples from contrast groups of patients with chronic pancreatitis (Group 3, 25 participants), pancreas cancer (Group 4, 25 participants), type I or II diabetes mellitus (Group 5, 25 participants) and healthy volunteers (Group 6, 100 participants). All participants will be at least 18 years old. MicroRNAs will be measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) and pancreatic enzymes by mass spectrometry.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisDrug-associated AP: patients aged 18 or more years undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP |
| Group 2 | – | Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisOther cause AP: patients aged 18 or more years not undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP |
| Group 3 | – | Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisChronic pancreatitis: patients aged 18 or more years with symptomatic chronic pancreatitis confirmed by CT or MRI |
| Group 4 | – | Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisPancreas cancer: patients aged 18 or more years with biopsy proven pancreas cancer |
| Group 5 | – | Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisDiabetes mellitus: patients aged 18 or more years with type 1 or type 2 diabetes mellitus in receipt of insulin or oral hypoglycaemics |
| Group 6 | – | Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisHealthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants aged 18 years or more, comprised of 6 Groups: Group 1: Drug-associated AP Group 2: Other cause AP Group 3: Chronic pancreatitis Group 4: Pancreas Cancer Group 5: Diabetes mellitus Grouip 6: Healthy volunteers
Key inclusion criteria (6 listed)
- Drug-associated AP: patients ≥18 years old undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP and admitted to recruiting hospitals with a diagnosis of AP established by two of: (i) typical continuous upper abdominal pain (in this study for up to 2 days in duration prior to admission); (ii) amylase and/or lipase 3 or more times the upper limit of normal; (iii) characteristic findings on abdominal imaging (if undertaken urgently by computerised tomography scan (CT) or magnetic resonance imaging (MRI); and who undergo their first study blood sampling within 24 hours of admission to hospital.
- Other cause AP: patients ≥18 years old not undergoing drug treatment that has a defined risk of AP and admitted to recruiting hospitals with a diagnosis of AP established by two of: (i) typical continuous upper abdominal pain (in this study for up to 2 days in duration prior to admission); (ii) amylase and/or lipase 3 or more times the upper limit of normal; (iii) characteristic findings on abdominal imaging (if undertaken urgently by CT or MRI) and undergo their first study blood sampling within 24 hours of hospital admission.
- Chronic pancreatitis: patients with symptomatic chronic pancreatitis and diagnostic abnormalities identified by CT and/or MRI and who undergo study blood sampling as an outpatient.
- Pancreatic cancer: patients presenting with biopsy-proven or presumed pancreatic cancer and who undergo study blood sampling as an outpatient; in patients with a presumptive diagnosis of pancreatic cancer, blood and urine samples will be analysed after histological confirmation.
- Diabetes mellitus: adult patients with type 1 or type 2 diabetes mellitus treated with insulin and/or oral anti-hyperglycaemic medication for at least 3 months and ongoing and who undergo study blood sampling as an outpatient.
Key exclusion criteria (6 listed)
- Drug-associated AP: onset of continuous abdominal pain more than 2 days prior to admission to hospital; known previous AP within the last 3 months; known chronic pancreatitis; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; known prior type 1 or type 2 diabetes mellitus. Patients will not be excluded if they are undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP and an alternative cause for AP is identified (including after recruitment and blood sampling).
- Other cause AP: undergoing drug treatment that has a defined risk of AP (such patients should be considered for recruitment into Group 2); onset of continuous abdominal pain more than 2 days prior to admission to hospital; known previous AP within the last 3 months; known chronic pancreatitis; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; type 1 or type 2 diabetes mellitus.
- Chronic pancreatitis: hospital admission with AP within the last three months; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; type 1 or type 2 diabetes mellitus.
- Pancreatic cancer: hospital admission with AP within the last 3 months; known chronic pancreatitis; previous necrosectomy or pancreatic surgery and/or chemotherapy prior to sampling; type 1 or type 2 diabetes mellitus.
- Diabetes mellitus: hospital admission with AP within the last 3 months; known type 3c diabetes mellitus; known history of acute or chronic pancreatitis; known history of cystic fibrosis, known history of pancreatic or hepatobiliary malignancy; known history of necrosectomy or pancreatic surgery; gestational diabetes mellitus; monogenic diabetes mellitus syndromes; post-transplantation diabetes mellitus; diabetes mellitus attributed to drugs or toxins.
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 |
|---|---|---|
| Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitisPanel of microRNA and pancreatic enzyme biomarkers | Diagnostic test | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
MicroRNA panel
Time frame: Day of admission
Scale of change from normal (healthy volunteer values) of a panel of microRNAs measured in blood and urine samples from patients with mild, moderate or severe drug-associated AP during the first 24 hours of admission, confirming specificity by comparison with results from patients with other pancreatic diseases
5 secondary outcomes
Pancreatic enzyme biomarker
Time frame: Day of admission
MicroRNA panel
Time frame: Days 4 and 14 after admission
Severity of AP
Time frame: Within 90 days of admission
Patient reported outcome
Time frame: Days 4 and 14
Progress of MAP-1
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Pancreatitis Drug-Induced
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Robert Sutton, MD FRCS PhD principal investigator
University of Liverpool
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis Drug-Induced, run by University of Liverpool at 4 sites in 3 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 6 inclusion and 6 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Germany, Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MicroRNA panel (time frame: Day of admission). 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 19 Feb 2026.