AnticoagulantPhase 1NCT05788900
Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Intravenous Administration
A Phase 1 study testing Heparin in people with Anticoagulant, run by Blau Farmaceutica S.A..
Trial summary
Pharmacodynamic Study - Phase I Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/mL; Blau Farmacêutica S/A. Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/mL; Fresenius Kabi Lake Zurich. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anticoagulant
- What is being tested?
- Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Sep 2023
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent approved by a Research Ethics Committee (CEP) prior to any trial-related activities;
- Healthy male or female participants between 18 and 55 years of age;
- Be in good health or have no significant illness at the discretion of the responsible researcher/physician, in accordance with what is defined in this protocol and the assessments to which he/she is submitted during recruitment and selection, such as: clinical history, vital signs, anthropometric data, physical examination , ECG and laboratory tests;
- Have a body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2, inclusive;
- Present body weight between 60 and 100 Kg;
- Agree to abstain from alcohol consumption for the duration of the study;
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- Present a negative result for the test for detecting alcohol in urine or saliva;
- Test negative for the coronavirus (SARS-CoV-2);
- Be able to understand the nature and purpose of the study, including risks and adverse events;
- Act in accordance with the requirements of the entire trial, which is confirmed by signing the Free and Informed Consent Form (TCLE);
- The drug can bring serious risks to the fetus, so the research participant, whether female or male, must agree to use a safe contraceptive method. Male participants must refrain from donating sperm from admission to final visit*
Who cannot join
- Present flu-like symptoms that, at the physician's discretion, are suspected of being infected by the coronavirus within 7 days prior to the period of hospitalization;
- Having had direct and significant contact at medical discretion with people who tested positive for the coronavirus (SARS-CoV-2) test within 14 days prior to the hospitalization period;
- Known to have a hypersensitivity reaction to the studied drug, pork foods or chemically related compounds;
- Have used regular medication within 14 days prior to the hospitalization period;
- Have used any medication within 7 days prior to the hospitalization period, except for contraceptives, cases in which, based on the half-life of the drug and/or active metabolites, complete elimination can be assumed or that, at the discretion of the responsible investigator/physician does not interfere in the pharmacokinetics or in the analytical stage of the study drug;
- Having received any vaccine dose within 7 days prior to the hospitalization period;
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- Have received, within the three months prior to the study, treatment with any drug known to have well-defined toxic potential in large organs;
- Have participated in any experimental study or ingested any experimental drug within the six months prior to the start of this study;
- Have been hospitalized for any reason up to eight weeks before the start of the first treatment period of this study;
- Have a history of liver, gastrointestinal or other conditions that may interfere with the absorption, distribution, metabolism or excretion of the drug;
- Have a history of renal, respiratory, hematological, cardiological, neurological, neoplastic or psychiatric disease considered clinically significant at the physician's discretion;
- Have a history of cardiac surgery (whatever), renal (renal exeresis or agenesis), gastrointestinal (partial or total removal of the esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid and rectum ) and surgery of the liver or pancreas;
- Have any current symptom or disease, acute or chronic, being monitored or treated, significant at the discretion of the responsible researcher/physician;
- Possess any active systemic or immunological disease or condition, including but not limited to the following general categories: cardiovascular/pulmonary, hepatic, renal or systemic infection or lactation;
- Electrocardiographic findings not recommended at the physician's discretion for participation in the study;
- Have the results of laboratory tests performed in the clinical evaluation of recruitment outside the values considered normal according to the reference values stipulated by the clinical analysis laboratory, unless they are considered non-clinically significant by the researcher in charge/physician;
- Have results of laboratory tests that, according to medical evaluation, affect the safety of the research participant;
- Present clinically significant abnormalities on physical examination;
- Have donated blood in the last 30 days;
- Individuals taking aspirin or any other non-steroidal anti-inflammatory agent, with or without a doctor's prescription, within 10 days of treatment;
- Clinically significant abnormality in vital signs or electrocardiogram (ECG), as judged by the investigator;
- Known allergic or undesirable reactions following the use of unfractionated heparin;
- Subjects who will undergo any surgical procedure within 14 days after the conclusion of the study;
- Failure to show up for the coronavirus (SARS-CoV-2) test before admission;
- Present a positive or inconclusive test for the coronavirus before admission;
- Present a positive test for pregnancy during pre-hospitalization;
- Present a positive result for the test for alcohol detection through urine or saliva;
- Have a positive preliminary drug test with methamphetamine, opiate/morphine, marijuana/tetrahydrocannabinol, amphetamine, cocaine/benzoylecgonine and/or benzodiazepine;
- Being a smoker or having quit smoking less than 6 months ago;
- Have a history of illicit drug abuse;
- Have an average alcohol intake of more than 3 alcoholic drinks in one day, or more than 7 alcoholic drinks per week, for women and more than 4 alcoholic drinks in one day, or more than 14 alcoholic drinks alcoholic beverages per week, for men;
- Have consumed alcohol and/or drugs in the 48 hours prior to the period of hospitalization;
- Having the habit of drinking more than five cups of coffee or tea a day;
- Ingest food or drinks containing xanthines in the 48 hours prior to hospitalization;
- Having done some intense physical exercise in the 48 hours prior to hospitalization;
- Having unusual or restricted eating habits decisions at the discretion of the responsible researcher/physician;
- Be pregnant or breastfeeding, suspect pregnancy or wish to become pregnant while conducting the study;
- Have donated or lost 450 mL or more of blood in the last three months;
- Have donated or lost more than 1500 mL of blood in the last twelve months;
- Show inability to stay awake or lying down for 1 hour or time required at the doctor's discretion;
- Have any condition that prevents participation in the study at the discretion of the researcher in charge/physician;
- Research participant who has participated in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J).
Trial locations and contacts
No sites are listed yet.
Research Operations contact
About this study
Official title: Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacodynamics of an Unfractionated Heparin Compared to Heparin Sodium Injection, USP (Comparator) After Intravenous Administration in Healthy Subjects
Pharmacodynamic Study - Phase I
Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/mL; Blau Farmacêutica S/A.
Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/mL; Fresenius Kabi Lake Zurich.
Evaluate the equivalence in terms of pharmacodynamics of heparin sodium (test product) and Heparin Sodium Injection, USP (comparator product). The clinical trial will last approximately 08 weeks and the study population will consist of 68 healthy research participants, 34 women and 34 men.
- Conditions
- Anticoagulant
- Being tested
- Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinBiological
intravenous Heparin
| Study group | Role | What they receive |
|---|---|---|
| Reference Drug | Active comparator | Healthy participants using intravenous Heparin Sodium Injection, USP (Fresenius Kabi) to assess the pharmacodynamic profile Receives: Biological: Heparin |
| Test Drug | Experimental | Healthy participants using intravenous Heparin Test to assess the pharmacodynamic profile Receives: Biological: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Amax parameter pharmacodynamics for the anti-FXA marker
Amax: Maximum response, understood as the highest concentration, detected in plasma after treatment.
The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of ASCE0-t parameter pharmacodynamics for the anti-FXA marker
ASCE0-T: area under the effect-based effect curve versus time from zero to the last experimentally determined concentration; The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of ASCE0-inf parameter pharmacodynamics for the anti-FXA marker
ASCE0-inf: Area under the effect curve based on concentration versus time from zero to infinity experimentally determined.
The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of Amax parameter pharmacodynamics for the anti-FIIA marker
Amax: Maximum response, understood as the highest concentration, detected in plasma after treatment.
The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of ASCE0-t parameter pharmacodynamics for the anti-FIIA marker
ASCE0-T: area under the effect-based effect curve versus time from zero to the last experimentally determined concentration; The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Secondary outcomes (7)
Sequence effects of pharmacodynamic parameters for the Anti-FXa marker - Analysis of variance (ANOVA)
Amax and ASCEo-t and ASCEo-inf parameters will be analyzed by analyzing ANOVA variance to evaluate the sequence effects of the anti-fii marker
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Sequence effects of pharmacodynamic parameters for the Anti-FIIa marker - Analysis of variance (ANOVA)
Amax and ASCEo-t parameters will be analyzed by analyzing ANOVA variance to evaluate the sequence effects of the anti-fii marker
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Ratio of Anti-FXa/Anti-FIIa activity based on the pharmacodynamic parameter ASCE0-t
The ratio for anti-FXa/anti-FIIa activity of the ASCE0-t parameter will be evaluated. , the evaluation will be performed by comparing the interval of 90% of the ratio with the equivalence criterion 80% - 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Occurrence of adverse events and serious eventsevents
Adverse events will be monitored for two months and reported in the final report.
- Total of adverse events;
- Total number of research participants who had adverse events;
- Number of adverse events per period;
- Number of adverse events due to causality;
- Number of adverse events by type of medicine (formulation);
- Number of adverse EA intensity events.
Measured: 2 months
Evaluation of Amax parameter pharmacodynamics for the tissue factor pathway inhibitor (TFPI) activity
TFPI serum concentrations will be quantified by ELISA method.
will be evaluated by comparing the 90% interval for the ratios with the acceptance criteria 80% - 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of ASCEo-t parameter pharmacodynamics for the tissue factor pathway inhibitor (TFPI) activity
TFPI serum concentrations will be quantified by ELISA method.
will be evaluated by comparing the 90% interval for the ratios with the acceptance criteria 80% - 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of ASCEo-inf parameter pharmacodynamics for the tissue factor pathway inhibitor (TFPI) activity
TFPI serum concentrations will be quantified by ELISA method.
will be evaluated by comparing the 90% interval for the ratios with the acceptance criteria 80% - 125%.
Measured: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blau Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Research, Study director, Blau Farmaceutica S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788900
- Sponsor's protocol ID
- CAEP 98.001.22
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacodynamics of an Unfractionated Heparin Compared to Heparin Sodium Injection, USP (Comparator) After Intravenous Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05788900
- Acronym / sponsor ID
- CAEP 98.001.22
- Conditions
- Anticoagulant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Blau Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 29 Mar 2023 (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.
Pharmacodynamic Study - Phase I
Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/mL; Blau Farmacêutica S/A.
Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/mL; Fresenius Kabi Lake Zurich.
Evaluate the equivalence in terms of pharmacodynamics of heparin sodium (test product) and Heparin Sodium Injection, USP (comparator product). The clinical trial will last approximately 08 weeks and the study population will consist of 68 healthy research participants, 34 women and 34 men.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Drug | Active comparator | Biological: HeparinHealthy participants using intravenous Heparin Sodium Injection, USP (Fresenius Kabi) to assess the pharmacodynamic profile |
| Test Drug | Experimental | Biological: HeparinHealthy participants using intravenous Heparin Test to assess the pharmacodynamic profile |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provide written informed consent approved by a Research Ethics Committee (CEP) prior to any trial-related activities;
- Healthy male or female participants between 18 and 55 years of age;
- Be in good health or have no significant illness at the discretion of the responsible researcher/physician, in accordance with what is defined in this protocol and the assessments to which he/she is submitted during recruitment and selection, such as: clinical history, vital signs, anthropometric data, physical examination , ECG and laboratory tests;
- Have a body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2, inclusive;
- Present body weight between 60 and 100 Kg;
Key exclusion criteria (42 listed)
- Present flu-like symptoms that, at the physician's discretion, are suspected of being infected by the coronavirus within 7 days prior to the period of hospitalization;
- Having had direct and significant contact at medical discretion with people who tested positive for the coronavirus (SARS-CoV-2) test within 14 days prior to the hospitalization period;
- Known to have a hypersensitivity reaction to the studied drug, pork foods or chemically related compounds;
- Have used regular medication within 14 days prior to the hospitalization period;
- Have used any medication within 7 days prior to the hospitalization period, except for contraceptives, cases in which, based on the half-life of the drug and/or active metabolites, complete elimination can be assumed or that, at the discretion of the responsible investigator/physician does not interfere in the pharmacokinetics or in the analytical stage of the study drug;
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 |
|---|---|---|
| Heparinintravenous Heparin | Biological | Reference Drug, Test Drug |
Primary outcome
Evaluation of Amax parameter pharmacodynamics for the anti-FXA marker
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Amax: Maximum response, understood as the highest concentration, detected in plasma after treatment. The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
Evaluation of ASCE0-t parameter pharmacodynamics for the anti-FXA marker
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
ASCE0-T: area under the effect-based effect curve versus time from zero to the last experimentally determined concentration; The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%
Evaluation of ASCE0-inf parameter pharmacodynamics for the anti-FXA marker
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
ASCE0-inf: Area under the effect curve based on concentration versus time from zero to infinity experimentally determined. The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
Evaluation of Amax parameter pharmacodynamics for the anti-FIIA marker
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Amax: Maximum response, understood as the highest concentration, detected in plasma after treatment. The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
Evaluation of ASCE0-t parameter pharmacodynamics for the anti-FIIA marker
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
ASCE0-T: area under the effect-based effect curve versus time from zero to the last experimentally determined concentration; The conclusion by the average equivalence is achieved when the confidence intervals 90% of the ratio of geometric averages of experimental and comparator drugs are between 80% and 125%.
7 secondary outcomes
Sequence effects of pharmacodynamic parameters for the Anti-FXa marker - Analysis of variance (ANOVA)
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Sequence effects of pharmacodynamic parameters for the Anti-FIIa marker - Analysis of variance (ANOVA)
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Ratio of Anti-FXa/Anti-FIIa activity based on the pharmacodynamic parameter ASCE0-t
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Occurrence of adverse events and serious eventsevents
Time frame: 2 months
Evaluation of Amax parameter pharmacodynamics for the tissue factor pathway inhibitor (TFPI) activity
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of ASCEo-t parameter pharmacodynamics for the tissue factor pathway inhibitor (TFPI) activity
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Evaluation of ASCEo-inf parameter pharmacodynamics for the tissue factor pathway inhibitor (TFPI) activity
Time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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.
Research Operations contact
Clinical Research study director
Blau Farmaceutica S.A.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heparin in people with Anticoagulant, run by Blau Farmaceutica S.A..
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 11 inclusion and 42 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blau Farmacêutica (114615-9400, pesquisaclinica@blau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Amax parameter pharmacodynamics for the anti-FXA marker (time frame: 12 hours of blood collection from the administration of the test drug and 12 hours of blood collection from the administration of the reference drug. The doses will be separated by a minimum interval of 14 days.). The study lists 5 primary outcomes in all. 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 29 Mar 2023.