Polycystic Kidney Disease, AdultPhase 3ALERTNCT04152837
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
A Phase 3 study testing Lixivaptan in people with Polycystic Kidney Disease, Adult and ADPKD, run by Palladio Biosciences at 6 sites in United States.
Trial summary
This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Polycystic Kidney Disease, Adult, ADPKD
- What is being tested?
- Lixivaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Sep 2020to 29 Jul 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 65 years of age (inclusive) at the time of Screening.
- Documented diagnosis of ADPKD by imaging or genetic analysis previously treated with tolvaptan for that indication.
- Screening eGFR ≥ 20 mL/min/1.73 m^2.
- Body mass index (BMI) between 18 and 35 kg/m^2 (inclusive) at the time of Screening.
- Documented history of:
- Based on upper limit of normal (ULN): At least 2 elevated alanine aminotransferase (ALT) levels; 1 ALT level >2 x ULN and 1 ALT level >3 x ULN while the participant was receiving tolvaptan, or within 4 weeks after tolvaptan discontinuation, with no other explanation for the ALT elevations. The 2 elevated ALT measurements could be recorded during the same instance of liver injury or during distinct instances; OR
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- Based on the participant's stable baseline as determined by the Investigator: At least 2 elevated ALT levels; 1 ALT level >2 x the participant's stable baseline level and 1 ALT level >3 x the participant's stable baseline level while the participant was receiving tolvaptan, or within 4 weeks after tolvaptan discontinuation, with no other explanation for the ALT elevations; provided that at least one ALT elevation was >2 x ULN. The 2 elevated ALT measurements could be recorded during the same instance of liver injury or during distinct instances; OR
- A pattern of ALT elevations deemed by the Investigator to be consistent with tolvaptan liver injury with no other explanation for the ALT elevations and agreement of the medical monitor and sponsor.
- Permanent discontinuation of prior tolvaptan treatment because of the ALT abnormality.
- If re-challenge with tolvaptan was performed, the ALT level must have increased to >2 x ULN upon rechallenge or the ALT level was increasing but tolvaptan was stopped for patient safety reasons before it reached > 2 x ULN after having previously normalized.
- Appropriate control of hypertension including an angiotensin converting enzyme inhibitor or angiotensin receptor blocker (unless not considered appropriate for the participant) without the use of a diuretic in concert with Kidney Disease: Improving Global Outcomes "Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease".
- Willing to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential).
- Able to provide informed consent.
Who cannot join
- Known sensitivity or idiosyncratic reaction to any compound present in lixivaptan and related compounds.
- Hypovolemia at Screening.
- Abnormal serum sodium concentration at Screening.
- Subjects who have taken any investigational drug or used an investigational device within 30 days, or 5 half-lives, whichever is longer, prior to Screening.
- Subjects who are taking, have taken within the past 2 weeks, or are expected to be taking, strong or moderate CYP3A4 or CYP2C8 inhibitors or inducers including regular use of grapefruit juice, Seville oranges, or St. John's wort.
- Simvastatin at total daily doses >10 mg or amlodipine at total daily doses >5 mg.
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- Use of tolvaptan within the 3 months prior to Screening or until a previously elevated ALT level has returned to ≤1 x ULN for at least 3 months.
- Use of lixivaptan or participation in a clinical study with lixivaptan within the 3 months prior to Screening.
- Use of conivaptan, somatostatin analogs (e.g., lanreotide, pasireotide, octreotide, etc.), metformin, nicotinamide, bardoxolone, venglustat, demeclocycline, or mammalian Target of Rapamycin (mTOR) kinase inhibitors (e.g., everolimus, sirolimus, etc.) to treat ADPKD within the 3 months prior to Screening.
- Requirement for chronic diuretic use.
- History of advanced diabetes (e.g., glycosylated hemoglobin [HgbA1c] >7.5%, and/or glycosuria by dipstick, significant proteinuria [>300 mcg albumin/mg creatinine]), other significant renal disease, transplanted kidney, recent kidney surgery within the 6 months prior to Screening (including cyst drainage or fenestration) or acute kidney injury within the 6 months prior to Screening.
- Clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia).
- New York Heart Association Functional Class 3 or 4 heart failure or other significant cardiac or electrocardiogram (ECG) findings that could pose a safety risk to the participant.
- Clinically significant liver disease or impairment or active chronic hepatitis at Screening.
- Positive test results for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody.
- History of infection with human immunodeficiency virus (HIV) unless the participant is stable and doing well on a non-CYP interacting anti-retroviral therapy (ART) regimen and who has not required more than 2 changes in their ART regimen.
- ALT or aspartate aminotransferase (AST) values >1.5 x ULN during Screening/Baseline.
- Total bilirubin values >1.0 x ULN during Screening/Baseline.
- History of drug or alcohol abuse in the 2 years prior to Screening.
- Any malignancy within the 5 years prior to Screening except for basal cell carcinoma successfully treated with local therapy.
- Medical history or findings that preclude safe participation in the study or who are likely to be non-compliant with study procedures in the opinion of the Investigator or medical monitor.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18107
University of Chicago Medicine & Biological Sciences
Chicago, Illinois, 60637
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, 22033
University of California Los Angeles
Los Angeles, California, 90025
Mayo Clinic
Rochester, Minnesota, 55905
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study
This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Up to 50 eligible participants will be enrolled and treated with lixivaptan for 52 weeks following titration to an optimal dose.
Read the detailed description
This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Up to 50 participants will be enrolled and treated. Evaluations will include frequent testing of liver chemistry (every week during the Baseline and Titration Periods and every 4 weeks during the Maintenance Period), physical examinations, vital signs, safety labs (serum chemistry, hematology, urinalysis), estimated glomerular filtration rate (eGFR), urine specific gravity and osmolality determinations and trough serum concentration of lixivaptan. After meeting entry criteria during a 1- to 3-week Screening Period that can extend up to 8 weeks for medication adjustment, participants will enter a 3-week no study treatment Baseline Period to obtain baseline measurements followed by a 3- to 6-week Titration Period during which lixivaptan administered twice daily (BID) will be titrated to a dose that is tolerated and results in a reduced trough urine specific gravity, or to the maximum dose level. The minimum dose to enter the Maintenance Period is 100 mg BID. Treatment will continue for up to 52 weeks (12 months) after which study drug will be held, and final assessments obtained during the Follow-up Period of 4 weeks. The total study duration will be up to approximately 73 weeks (16.8 months).
- Conditions
- Polycystic Kidney Disease, Adult, ADPKD
- Being tested
- Lixivaptan
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LixivaptanDrug
Oral vasopressin V2 receptor antagonist
| Study group | Role | What they receive |
|---|---|---|
| Lixivaptan | Experimental | Lixivaptan oral capsules, 100-200 mg twice daily Receives: Drug: Lixivaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Develop Serum Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment
Number of participants who develop serum ALT levels >3 x ULN which are assessed by the independent Hepatic Events Review Committee (HERC) to be at least probably related to lixivaptan and result in the discontinuation of lixivaptan treatment. The independent HERC, after reviewing demographic, medical and medication history, safety data and other relevant data of participants who develop liver abnormalities, will determine the probable causality for liver chemistry test abnormalities of concern and the relatedness to lixivaptan using the Drug-Induced Liver Injury Network probability criteria (Fontana et al., 2009). The normal range of ALT was defined as 0-55 U/L.
Measured: Up to 58 weeks
Secondary outcomes (7)
Number of Participants Who Develop Serum ALT Levels >5 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment
Number of participants who develop serum ALT levels >5 x ULN which are assessed by the independent HERC to be at least probably related to lixivaptan and result in the discontinuation of lixivaptan treatment. The independent HERC, after reviewing demographic, medical and medication history, safety data and other relevant data of participants who develop liver abnormalities, will determine the probable causality for liver chemistry test abnormalities of concern and the relatedness to lixivaptan using the Drug-Induced Liver Injury Network probability criteria (Fontana et al., 2009). The normal range of ALT was defined as 0-55 U/L.
Measured: Up to 58 weeks
Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Dose Reduction of Lixivaptan Treatment
Number of participants who develop serum ALT levels >3 x ULN which are assessed by the independent HERC to be at least probably related to lixivaptan and result in the dose reduction of lixivaptan treatment. The independent HERC, after reviewing demographic, medical and medication history, safety data and other relevant data of participants who develop liver abnormalities, will determine the probable causality for liver chemistry test abnormalities of concern and the relatedness to lixivaptan using the Drug-Induced Liver Injury Network probability criteria (Fontana et al., 2009). The normal range of ALT was defined as 0-55 U/L.
Measured: Up to 58 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs during the Titration Period, the Maintenance Period, or the Follow-up Period.
Measured: Up to 62 weeks
Number of Participants With Potentially Clinically Important Clinical Laboratory Findings
Number of participants with clinical laboratory findings (non-hepatic clinical chemistry, hematology, and urinalysis) recorded during the Titration Period, the Maintenance Period, or the Follow-up Period, and considered to be potentially clinically important.
Measured: Up to 62 weeks
Number of Participants With Potentially Clinically Important Vital Signs Findings
Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded during the Titration Period, the Maintenance Period, or the Follow-up Period, and considered to be potentially clinically important.
Measured: Up to 62 weeks
Number of Participants With Potentially Clinically Important 12-lead Electrocardiogram (ECG) Findings
Number of participants with ECG findings recorded during the Titration Period, the Maintenance Period, or the Follow-up Period, and considered to be potentially clinically important (defined as a QT interval corrected for heart rate according to Fridericia's formula [QTcF] ≥ 450 msec).
Measured: Up to 62 weeks
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment
Baseline eGFR is defined as the mean of the 3 eGFR assessments obtained during the Baseline Period (if any values are missing, the remaining values will be used to determine the baseline eGFR). The endpoint eGFR is defined as the mean of 3 eGFR assessments obtained during the Follow-up Period (if any values are missing, the remaining values will be used to determine the endpoint eGFR). The change in eGFR from Baseline to Final Assessment will be provided.
Measured: Up to 62 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start2 Sep 2020
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Why it stopped: The decision is based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD
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 Polycystic Kidney Disease, AdultStudies 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
- Model description
- Open-label, single treatment group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palladio Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centessa Pharmaceuticals plc
- Responsible party
- Sponsor
- Investigators
- Arlene Chapman, MD, Principal investigator, University of Chicago, Chicago, IL USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152837
- Sponsor's protocol ID
- PA-ADPKD-303
- Acronym
- ALERT
- Status last verified
- Mar 2023
- First submitted
- 31 Oct 2019
- Last updated
- 10 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J; DILIN Study Group. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55-68. doi: 10.2165/00002018-200932010-00005.
PubMed 19132805
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study
- ClinicalTrials.gov ID
- NCT04152837
- Acronym / sponsor ID
- ALERT / PA-ADPKD-303
- Conditions
- Polycystic Kidney Disease, Adult, ADPKD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision is based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Palladio BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Centessa Pharmaceuticals plc
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Posted 10 Apr 2023
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 Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Up to 50 eligible participants will be enrolled and treated with lixivaptan for 52 weeks following titration to an optimal dose.
Detailed description
This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Up to 50 participants will be enrolled and treated. Evaluations will include frequent testing of liver chemistry (every week during the Baseline and Titration Periods and every 4 weeks during the Maintenance Period), physical examinations, vital signs, safety labs (serum chemistry, hematology, urinalysis), estimated glomerular filtration rate (eGFR), urine specific gravity and osmolality determinations and trough serum concentration of lixivaptan. After meeting entry criteria during a 1- to 3-week Screening Period that can extend up to 8 weeks for medication adjustment, participants will enter a 3-week no study treatment Baseline Period to obtain baseline measurements followed by a 3- to 6-week Titration Period during which lixivaptan administered twice daily (BID) will be titrated to a dose that is tolerated and results in a reduced trough urine specific gravity, or to the maximum dose level. The minimum dose to enter the Maintenance Period is 100 mg BID. Treatment will continue for up to 52 weeks (12 months) after which study drug will be held, and final assessments obtained during the Follow-up Period of 4 weeks. The total study duration will be up to approximately 73 weeks (16.8 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single treatment group
| Arm | Type | Receives |
|---|---|---|
| Lixivaptan | Experimental | Drug: LixivaptanLixivaptan oral capsules, 100-200 mg twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, between 18 and 65 years of age (inclusive) at the time of Screening.
- Documented diagnosis of ADPKD by imaging or genetic analysis previously treated with tolvaptan for that indication.
- Screening eGFR ≥ 20 mL/min/1.73 m^2.
- Body mass index (BMI) between 18 and 35 kg/m^2 (inclusive) at the time of Screening.
- Documented history of:
Key exclusion criteria (21 listed)
- Known sensitivity or idiosyncratic reaction to any compound present in lixivaptan and related compounds.
- Hypovolemia at Screening.
- Abnormal serum sodium concentration at Screening.
- Subjects who have taken any investigational drug or used an investigational device within 30 days, or 5 half-lives, whichever is longer, prior to Screening.
- Subjects who are taking, have taken within the past 2 weeks, or are expected to be taking, strong or moderate CYP3A4 or CYP2C8 inhibitors or inducers including regular use of grapefruit juice, Seville oranges, or St. John's wort.
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 |
|---|---|---|
| LixivaptanOral vasopressin V2 receptor antagonist | Drug | Lixivaptan |
Primary outcome
Number of Participants Who Develop Serum Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment
Time frame: Up to 58 weeks
Number of participants who develop serum ALT levels >3 x ULN which are assessed by the independent Hepatic Events Review Committee (HERC) to be at least probably related to lixivaptan and result in the discontinuation of lixivaptan treatment. The independent HERC, after reviewing demographic, medical and medication history, safety data and other relevant data of participants who develop liver abnormalities, will determine the probable causality for liver chemistry test abnormalities of concern and the relatedness to lixivaptan using the Drug-Induced Liver Injury Network probability criteria (Fontana et al., 2009). The normal range of ALT was defined as 0-55 U/L.
7 secondary outcomes
Number of Participants Who Develop Serum ALT Levels >5 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment
Time frame: Up to 58 weeks
Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Dose Reduction of Lixivaptan Treatment
Time frame: Up to 58 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 62 weeks
Number of Participants With Potentially Clinically Important Clinical Laboratory Findings
Time frame: Up to 62 weeks
Number of Participants With Potentially Clinically Important Vital Signs Findings
Time frame: Up to 62 weeks
Number of Participants With Potentially Clinically Important 12-lead Electrocardiogram (ECG) Findings
Time frame: Up to 62 weeks
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment
Time frame: Up to 62 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19132805Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J; DILIN Study Group. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55-68. doi: 10.2165/00002018-200932010-00005.
- 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.
Arlene Chapman, MD principal investigator
University of Chicago, Chicago, IL USA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lixivaptan in people with Polycystic Kidney Disease, Adult and ADPKD, run by Palladio Biosciences at 6 sites 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 13 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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 10 Apr 2023). 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 Who Develop Serum Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment (time frame: Up to 58 weeks). 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 NCT04152837, 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 10 Apr 2023.