Liver DiseasesNCT07580482
The Referral to Hepatology Can be Improved Through an Electronic Medical Record (EMR)-Based Best Practice Alert (BPA) for an Appropriate Referral
A study testing Best Practice Alert in people with Liver Diseases and Liver Fat, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to promote the diagnosis and awareness of Non-Alcoholic Steatohepatitis (NASH) by linkage of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Liver Fat, Diabetes Mellitus, Type 2
- What is being tested?
- Best Practice Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 15 Jul 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providers from internal medicine, family medicine and endocrinology clinics.
Who cannot join
- Providers may choose to opt-out from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to promote the diagnosis and awareness of Non-Alcoholic Steatohepatitis (NASH) by linkage of care.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is an extremely common condition affecting 26% of the US general population but only 2% of the population has a more aggressive histological phenotype, nonalcoholic steatohepatitis (NASH) or evidence of liver fibrosis[1]. The American Association for the Study of Liver Diseases (AASLD) does not recommend routine screening of the general population for NAFLD[2] citing "uncertainties surrounding diagnostic tests and treatment options[3]", but does recommend referral to a hepatologist when there is a high index of suspicion for NASH and advanced fibrosis such as in patients with type 2 diabetes (T2D)[4-6], and in those with elevated fibrosis-4 index (FIB-4) [7, 8]. These aids are under-utilized by physicians that result in many patients who are at high risk for fibrosis and are not referred to hepatology[9]. Confusion regarding how to best define the population at risk is a major problem preventing the appropriate use of hepatology referral in the primary care setting.
- Being tested
- Best Practice Alert, No Intervention
- Medical subject headings
- Liver Diseases, Fatty Liver, Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice AlertBehavioural
To determine if rates of screening and referral to hepatology can be improved through an EMR-based BPA for an appropriate referral.
No InterventionBehavioural
The only intervention is the Best Practice Alert (BPA). Providers from three departments will be randomized to one of two groups: one that receives a BPA and one that does not. Thereafter, the study will observe patients who fit criteria for NASH referral, as defined by a diagnosis of T2DM and appropriate Fib4 score to determine if they have been referred to Hepatology for assessment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Unit: | Experimental | Providers from internal medicine, family medicine and endocrinology clinics. Receives: Behavioral: Best Practice Alert |
| Observation Unit: | Other | Patients from internal medicine, family medicine, and endocrinology clinics. Patients with an ICD 10 diagnosis of T2D E11.9. Patients have the most recent calculated FIB-4 Score of >3.25. Receives: Behavioral: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if rates of referral to hepatology can be improved through EMR-based Best Practice Alert (BPA) for an appropriate referral. Name of the specific primary outcome measure
Quantify the number of new referrals from providers who opt-in to have BPA notifications.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Jul 2020
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Winston Dunn, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580482
- Sponsor's protocol ID
- STUDY00145358
- Other IDs
- IN-US-989-5752
- Status last verified
- May 2026
- First submitted
- 24 Jun 2021
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Jul;38(7):1347-55. doi: 10.2337/dc14-1239. Epub 2015 Apr 17.
PubMed 25887357Knight AM, Falade O, Maygers J, Sevransky JE. Factors associated with medication warning acceptance for hospitalized adults. J Hosp Med. 2015 Jan;10(1):19-25. doi: 10.1002/jhm.2258.
PubMed 25603789Carroll AE. Averting Alert Fatigue to Prevent Adverse Drug Reactions. JAMA. 2019 Aug 20;322(7):601. doi: 10.1001/jama.2019.11710. No abstract available.
PubMed 31429887Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
PubMed 27786365Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
PubMed 28130846Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
PubMed 24222016Dongiovanni P, Petta S, Mannisto V, Mancina RM, Pipitone R, Karja V, Maggioni M, Kakela P, Wiklund O, Mozzi E, Grimaudo S, Kaminska D, Rametta R, Craxi A, Fargion S, Nobili V, Romeo S, Pihlajamaki J, Valenti L. Statin use and non-alcoholic steatohepatitis in at risk individuals. J Hepatol. 2015 Sep;63(3):705-12. doi: 10.1016/j.jhep.2015.05.006. Epub 2015 May 14.
PubMed 25980762Scheen AJ. Beneficial effects of SGLT2 inhibitors on fatty liver in type 2 diabetes: A common comorbidity associated with severe complications. Diabetes Metab. 2019 Jun;45(3):213-223. doi: 10.1016/j.diabet.2019.01.008. Epub 2019 Jan 29.
PubMed 30708071Armstrong MJ, Gaunt P, Aithal GP, Barton D, Hull D, Parker R, Hazlehurst JM, Guo K; LEAN trial team; Abouda G, Aldersley MA, Stocken D, Gough SC, Tomlinson JW, Brown RM, Hubscher SG, Newsome PN. Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study. Lancet. 2016 Feb 13;387(10019):679-690. doi: 10.1016/S0140-6736(15)00803-X. Epub 2015 Nov 20.
PubMed 26608256Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.
PubMed 20427778Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10.
PubMed 25865049Musso G, Cassader M, Rosina F, Gambino R. Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials. Diabetologia. 2012 Apr;55(4):885-904. doi: 10.1007/s00125-011-2446-4. Epub 2012 Jan 27.
PubMed 22278337A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis (MAESTRO-NASH).
Al-Hihi E, Shankweiler C, Stricklen D, Gibson C, Dunn W. Electronic medical record alert improves HCV testing for baby boomers in primary care setting: adults born during 1945-1965. BMJ Open Qual. 2017 Oct 21;6(2):e000084. doi: 10.1136/bmjoq-2017-000084. eCollection 2017.
PubMed 29209663Oertel MJ, Graves L, Al-Hihi E, Leonardo V, Hopkins C, DeSouza K, Bhattacharya RK. Osteoporosis management in older patients who experienced a fracture. Clin Interv Aging. 2016 Aug 22;11:1111-6. doi: 10.2147/CIA.S107720. eCollection 2016.
PubMed 27578967
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Referral to Hepatology Can be Improved Through an Electronic Medical Record (EMR)-Based Best Practice Alert (BPA) for an Appropriate Referral
- ClinicalTrials.gov ID
- NCT07580482
- Acronym / sponsor ID
- STUDY00145358
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 12 May 2026 (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.
The purpose of this study is to promote the diagnosis and awareness of Non-Alcoholic Steatohepatitis (NASH) by linkage of care.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is an extremely common condition affecting 26% of the US general population but only 2% of the population has a more aggressive histological phenotype, nonalcoholic steatohepatitis (NASH) or evidence of liver fibrosis[1]. The American Association for the Study of Liver Diseases (AASLD) does not recommend routine screening of the general population for NAFLD[2] citing "uncertainties surrounding diagnostic tests and treatment options[3]", but does recommend referral to a hepatologist when there is a high index of suspicion for NASH and advanced fibrosis such as in patients with type 2 diabetes (T2D)[4-6], and in those with elevated fibrosis-4 index (FIB-4) [7, 8]. These aids are under-utilized by physicians that result in many patients who are at high risk for fibrosis and are not referred to hepatology[9]. Confusion regarding how to best define the population at risk is a major problem preventing the appropriate use of hepatology referral in the primary care setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Unit: | Experimental | Behavioral: Best Practice AlertProviders from internal medicine, family medicine and endocrinology clinics. |
| Observation Unit: | Other | Behavioral: No InterventionPatients from internal medicine, family medicine, and endocrinology clinics. Patients with an ICD 10 diagnosis of T2D E11.9. Patients have the most recent calculated FIB-4 Score of >3.25. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Providers from internal medicine, family medicine and endocrinology clinics.
Key exclusion criteria (1 listed)
- Providers may choose to opt-out from this study.
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 |
|---|---|---|
| Best Practice AlertTo determine if rates of screening and referral to hepatology can be improved through an EMR-based BPA for an appropriate referral. | Behavioural | Experimental Unit: |
| No InterventionThe only intervention is the Best Practice Alert (BPA). Providers from three departments will be randomized to one of two groups: one that receives a BPA and one that does not. Thereafter, the study will observe patients who fit criteria for NASH referral, as defined by a diagnosis of T2DM and appropriate Fib4 score to determine if they have been referred to Hepatology for assessment. | Behavioural | Observation Unit: |
Primary outcome
Determine if rates of referral to hepatology can be improved through EMR-based Best Practice Alert (BPA) for an appropriate referral. Name of the specific primary outcome measure
Time frame: 12 months
Quantify the number of new referrals from providers who opt-in to have BPA notifications.
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 12 May 2026.
- Background: PubMed 25887357Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Jul;38(7):1347-55. doi: 10.2337/dc14-1239. Epub 2015 Apr 17.
- Background: PubMed 25603789Knight AM, Falade O, Maygers J, Sevransky JE. Factors associated with medication warning acceptance for hospitalized adults. J Hosp Med. 2015 Jan;10(1):19-25. doi: 10.1002/jhm.2258.
- Background: PubMed 31429887Carroll AE. Averting Alert Fatigue to Prevent Adverse Drug Reactions. JAMA. 2019 Aug 20;322(7):601. doi: 10.1001/jama.2019.11710. No abstract available.
- Background: PubMed 27786365Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
- Background: PubMed 28130846Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
- Background: PubMed 24222016Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 25980762Dongiovanni P, Petta S, Mannisto V, Mancina RM, Pipitone R, Karja V, Maggioni M, Kakela P, Wiklund O, Mozzi E, Grimaudo S, Kaminska D, Rametta R, Craxi A, Fargion S, Nobili V, Romeo S, Pihlajamaki J, Valenti L. Statin use and non-alcoholic steatohepatitis in at risk individuals. J Hepatol. 2015 Sep;63(3):705-12. doi: 10.1016/j.jhep.2015.05.006. Epub 2015 May 14.
- Background: PubMed 30708071Scheen AJ. Beneficial effects of SGLT2 inhibitors on fatty liver in type 2 diabetes: A common comorbidity associated with severe complications. Diabetes Metab. 2019 Jun;45(3):213-223. doi: 10.1016/j.diabet.2019.01.008. Epub 2019 Jan 29.
- Background: PubMed 26608256Armstrong MJ, Gaunt P, Aithal GP, Barton D, Hull D, Parker R, Hazlehurst JM, Guo K; LEAN trial team; Abouda G, Aldersley MA, Stocken D, Gough SC, Tomlinson JW, Brown RM, Hubscher SG, Newsome PN. Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study. Lancet. 2016 Feb 13;387(10019):679-690. doi: 10.1016/S0140-6736(15)00803-X. Epub 2015 Nov 20.
- Background: PubMed 20427778Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.
- Background: PubMed 25865049Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10.
- Background: PubMed 22278337Musso G, Cassader M, Rosina F, Gambino R. Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials. Diabetologia. 2012 Apr;55(4):885-904. doi: 10.1007/s00125-011-2446-4. Epub 2012 Jan 27.
- Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE).Link provided by the sponsor.
- Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE).Link provided by the sponsor.
- AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH.Link provided by the sponsor.
- Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR 4).Link provided by the sponsor.
- Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS).Link provided by the sponsor.
- Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (STELLAR 3).Link provided by the sponsor.
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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.
Winston Dunn, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Alert in people with Liver Diseases and Liver Fat, run by University of Kansas Medical Center at 1 site in United States.
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 1 inclusion and 1 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Determine if rates of referral to hepatology can be improved through EMR-based Best Practice Alert (BPA) for an appropriate referral. Name of the specific primary outcome measure (time frame: 12 months). 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 NCT07580482, which also lists 25 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 12 May 2026.