Hepatic Insufficiency, Renal InsufficiencyPhase 1NCT03172884

Study of Copanlisib in Hepatic or Renal Impairment

A Phase 1 study testing Copanlisib (ALIQOPA, BAY80-6946) in people with Hepatic Insufficiency, Renal Insufficiency, run by Bayer at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency, Renal Insufficiency
What is being tested?: Copanlisib (ALIQOPA, BAY80-6946)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesin 2 countries
Study dates: 14 Jun 2017to 15 May 2020
Phase: Phase 1
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All subjects - Male and female subjects between 18 and 80 years of age with a body mass index above 18.0 and below 34.0 kg / m² and a body weight of above or equal 50 kg.
Healthy subjects
Healthy subjects as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations. eGFR ≥ 90 mL/min/1.73 m² (according to Modification of Diet in Renal Disease [MDRD] formula).
Subjects with moderate or severe hepatic impairment
Subjects with confirmed liver cirrhosis by at least one of the following Criteria: histologically by prior liver biopsy showing cirrhosis, liver imaging (computer tomography, and/or ultrasound and/or magnetic resonance imaging scans, and/or fibroscan), or laparoscopy.
Child-Pugh Clinical Assessment Score 7 to 9 (moderate) or Score 10 to 15 (severe).

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Subjects with severe renal impairment
Subjects with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m² according to MDRD formula.
Subjects with stable renal disease: no significant change in renal function as evidenced by serum creatinine value within ±25% from the last determination, obtained within at least 3 months before study entry and the absence of the need to start dialysis in the next 3 months.

Who cannot join

All subjects
Active coronary artery disease or myocardial infarction within 6 months of study entry. Immuno-compromised subjects including known history/seropositivity of human immunodeficiency virus (HIV).
Other concurrent severe and/or uncontrolled medical conditions (e.g. current diagnosis of type 1 or type 2 diabetes mellitus and with HbA1c >8.5%) that could cause unacceptable safety risks or compromise compliance with protocol.
Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder cancer as well as localized prostate cancer.
Uncontrolled hypertension despite optimal medical management (per investigator's assessment).
Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing and during study conduct. (A list of these medications can be found in Section 16.6 of the protocol. However, this list may not be comprehensive).

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Subjects with moderate or severe hepatic impairment
Symptoms or history of encephalopathy (Grade III or worse)
Failure of any other major organ other than the liver; severe infection, or any clinically significant illness within 4 weeks prior to study drug administration
Renal failure with an eGFR <35 mL/min/1.73 m² Subjects with severe renal impairment
Acute renal failure at study entry
Nephrotic syndrome
Failure of any other major organ other than the kidney
Acute hepatorenal syndrome

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 site

CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105

Other trials in Germany

Romania1 site

Institutul National de Boli Infectioase Prof.Dr.Matei Bals
Bucharest, 021105

Other trials in Romania

About this study

Official title: An Open-label Non-randomized, Phase 1 Single Dose Study to Evaluate the Pharmacokinetics and Safety of Copanlisib in Subjects With Impaired Hepatic or Renal Function in Comparison to Healthy Subjects

To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects

Conditions: Hepatic Insufficiency, Renal Insufficiency
Being tested: Copanlisib (ALIQOPA, BAY80-6946)
Keywords: Renal Impairment, Pharmacokinetics, Hepatic impairment, Envisaged indication: Treatment of cancer
Medical subject headings: Hepatic Insufficiency, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Copanlisib (ALIQOPA, BAY80-6946)Drug
12mg single dose, intravenous on Day 0

Study groups in NCT03172884
Study group	Role	What they receive
BAY80-6946/Healthy subject	Experimental	Healthy subjects Receives: Drug: Copanlisib (ALIQOPA, BAY80-6946)
BAY80-6946/moderate hepatically impaired patients	Experimental	Patients with Child-Pugh B (score 7-9) at the screening visit Receives: Drug: Copanlisib (ALIQOPA, BAY80-6946)
BAY80-6946/severe renal impaired patients	Experimental	Patients with eGFR 15-29 mL/min/1.73 m^2 at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation Receives: Drug: Copanlisib (ALIQOPA, BAY80-6946)
BAY80-6946/severe hepatically impaired patients	Experimental	Patients with Child-Pugh C (score 10-15) at the screening visit Receives: Drug: Copanlisib (ALIQOPA, BAY80-6946)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Concentration (Cmax) of Copanlisib in Plasma.
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
Area Under the Concentration vs. Time Curve From Zero to Infinity (AUC) of Copanlisib in Plasma.
AUC refers to area under the concentration vs time curve from 0 to infinity which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
Area Under the Concentration-time Curve of Copanlisib in Plasma Over the Time Interval From 0 to 168 h.
AUC(0-168) refers to AUC from time 0 to 168 hr which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion

Secondary outcomes (4)

Maximum Observed Concentration (Cmax) of Metabolite M-1.
The morpholinone derivative M-1 is a minor copanlisib metabolite in plasma. The PK of metabolite M-1 is routinely analyzed in addition to the PK of the parent compound, although M-1 is not considered to be a major metabolite. Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
Area Under the Concentration-time Curve of Metabolite M-1 in Plasma Over the Time Interval From 0 to 168 h.
The morpholinone derivative M-1 is a minor copanlisib metabolite in plasma. The PK of metabolite M-1 is routinely analyzed in addition to the PK of the parent compound, although M-1 is not considered to be a major metabolite. AUC from time 0 to 168h which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Measured: Up to 30 days after end of treatment with study drug
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) in Different Severity.
Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Measured: Up to 30 days after end of treatment with study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 201715 May 2020

First posted1 Jun 2017
Study start14 Jun 2017
Primary completion13 Mar 2020
Study completion15 May 2020

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.
Other trials for Hepatic Insufficiency, Renal InsufficiencyStudies of the same condition, open and under way.
More trials run by BayerThe 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 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03172884
Sponsor's protocol ID: 18041
Other IDs: 2016-004561-51, 2016
Status last verified: Apr 2021
First submitted: 30 May 2017
Last updated: 28 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hepatic Insufficiency, Renal Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Non-randomized, Phase 1 Single Dose Study to Evaluate the Pharmacokinetics and Safety of Copanlisib in Subjects With Impaired Hepatic or Renal Function in Comparison to Healthy Subjects
ClinicalTrials.gov ID: NCT03172884
Acronym / sponsor ID: 18041
Conditions: Hepatic Insufficiency, Renal Insufficiency
Keywords: Renal Impairment, Pharmacokinetics, Hepatic impairment, Envisaged indication: Treatment of cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 14 Jun 2017 (actual)
Primary completion: 13 Mar 2020 (actual)
Study completion: 15 May 2020 (actual)
First posted: 1 Jun 2017 (actual)
Results: Posted 1 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
BAY80-6946/Healthy subject	Experimental	Drug: Copanlisib (ALIQOPA, BAY80-6946)Healthy subjects
BAY80-6946/moderate hepatically impaired patients	Experimental	Drug: Copanlisib (ALIQOPA, BAY80-6946)Patients with Child-Pugh B (score 7-9) at the screening visit
BAY80-6946/severe renal impaired patients	Experimental	Drug: Copanlisib (ALIQOPA, BAY80-6946)Patients with eGFR 15-29 mL/min/1.73 m^2 at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation
BAY80-6946/severe hepatically impaired patients	Experimental	Drug: Copanlisib (ALIQOPA, BAY80-6946)Patients with Child-Pugh C (score 10-15) at the screening visit

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

All subjects - Male and female subjects between 18 and 80 years of age with a body mass index above 18.0 and below 34.0 kg / m² and a body weight of above or equal 50 kg.
Healthy subjects
Healthy subjects as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations. eGFR ≥ 90 mL/min/1.73 m² (according to Modification of Diet in Renal Disease [MDRD] formula).
Subjects with moderate or severe hepatic impairment
Subjects with confirmed liver cirrhosis by at least one of the following Criteria: histologically by prior liver biopsy showing cirrhosis, liver imaging (computer tomography, and/or ultrasound and/or magnetic resonance imaging scans, and/or fibroscan), or laparoscopy.

Key exclusion criteria (14 listed)

All subjects
Active coronary artery disease or myocardial infarction within 6 months of study entry. Immuno-compromised subjects including known history/seropositivity of human immunodeficiency virus (HIV).
Other concurrent severe and/or uncontrolled medical conditions (e.g. current diagnosis of type 1 or type 2 diabetes mellitus and with HbA1c >8.5%) that could cause unacceptable safety risks or compromise compliance with protocol.
Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder cancer as well as localized prostate cancer.
Uncontrolled hypertension despite optimal medical management (per investigator's assessment).

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
Copanlisib (ALIQOPA, BAY80-6946)12mg single dose, intravenous on Day 0	Drug	BAY80-6946/Healthy subject, BAY80-6946/moderate hepatically impaired patients, BAY80-6946/severe hepatically impaired patients, BAY80-6946/severe renal impaired patients

Primary outcome

Maximum Observed Concentration (Cmax) of Copanlisib in Plasma.
Time frame: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Area Under the Concentration vs. Time Curve From Zero to Infinity (AUC) of Copanlisib in Plasma.
Time frame: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
AUC refers to area under the concentration vs time curve from 0 to infinity which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Area Under the Concentration-time Curve of Copanlisib in Plasma Over the Time Interval From 0 to 168 h.
Time frame: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
AUC(0-168) refers to AUC from time 0 to 168 hr which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

4 secondary outcomes

Maximum Observed Concentration (Cmax) of Metabolite M-1.
Time frame: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
Area Under the Concentration-time Curve of Metabolite M-1 in Plasma Over the Time Interval From 0 to 168 h.
Time frame: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 30 days after end of treatment with study drug
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) in Different Severity.
Time frame: Up to 30 days after end of treatment with study drug

Results and safety

Results posted to the registry on 1 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate Hepatic Impairment Group	8	8
Severe Hepatic Impairment Group	6	6
Severe Renal Impairment Group	8	8
Healthy Participants	8	8

Primary outcome: Maximum Observed Concentration (Cmax) of Copanlisib in Plasma.

Time frame: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion. Geometric mean (Geometric Coefficient of Variation). Unit: μg/L

Measure	Moderate Hepatic Impairment Group n = 8	Severe Hepatic Impairment Group n = 6	Severe Renal Impairment Group n = 8	Healthy Participants n = 8
Value	68.12 (65.50)	71.09 (53.90)	31.77 (38.25)	49.20 (27.24)

Moderate Hepatic Impairment Group vs Healthy Participants: LS means: 1.385 (90% CI 0.921 to 2.081)
Severe Hepatic Impairment Group vs Healthy Participants: LS means: 1.445 (90% CI 0.998 to 2.093)
Severe Renal Impairment Group vs Healthy Participants: LS means: 0.646 (90% CI 0.486 to 0.858)

Primary outcome: Area Under the Concentration vs. Time Curve From Zero to Infinity (AUC) of Copanlisib in Plasma.

Measure	Moderate Hepatic Impairment Group n = 8	Severe Hepatic Impairment Group n = 6	Severe Renal Impairment Group n = 7	Healthy Participants n = 6
Value	594.9 (53.85)	940.7 (23.70)	373.7 (59.08)	347.8 (23.99)

Moderate Hepatic Impairment Group vs Healthy Participants: LS Means: 1.711 (90% CI 1.148 to 2.550)
Severe Hepatic Impairment Group vs Healthy Participants: LS Means: 2.705 (90% CI 2.115 to 3.460)
Severe Renal Impairment Group vs Healthy Participants: LS Means: 1.075 (90% CI 0.696 to 1.659)

Population analysed: Participants in PK population with available data are reported.

Primary outcome: Area Under the Concentration-time Curve of Copanlisib in Plasma Over the Time Interval From 0 to 168 h.

Measure	Moderate Hepatic Impairment Group n = 8	Severe Hepatic Impairment Group n = 6	Severe Renal Impairment Group n = 8	Healthy Participants n = 8
Value	551.4 (53.78)	853.0 (26.39)	350.5 (48.55)	311.9 (23.55)

Moderate Hepatic Impairment Group vs Healthy Participants: LS Means: 1.768 (90% CI 1.251 to 2.498)
Severe Hepatic Impairment Group vs Healthy Participants: LS Means: 2.735 (90% CI 2.163 to 3.459)
Severe Renal Impairment Group vs Healthy Participants: LS Means: 1.124 (90% CI 0.815 to 1.549)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first administration of study drug up to 30 days after end of treatment with study medication.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate Hepatic Impairment Group	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Severe Hepatic Impairment Group	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Severe Renal Impairment Group	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Healthy Participants	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
Individual participant dataSharing planned: No. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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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.

Bayer Study Director study director

Bayer

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Copanlisib (ALIQOPA, BAY80-6946) in people with Hepatic Insufficiency, Renal Insufficiency, run by Bayer at 2 sites in 2 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 9 inclusion and 14 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Romania. 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 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.

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 1 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?

Maximum Observed Concentration (Cmax) of Copanlisib in Plasma. (time frame: before copanlisib administration as well as 10 min and 1 h (end of infusion), 1.5, 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120 and 168 h after start of infusion). The study lists 3 primary outcomes in all. 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 NCT03172884.

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 28 Apr 2021.