Hepatitis BPhase 1NCT06160895
A Clinical Trial of TQ-A3334 Tablet After Multiple Administration in Adult Subjects
A Phase 1 study testing TQ-A3334 tablets in people with Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled Phase I clinical study of TQ-A3334 tablets in adult healthy subjects, and the trial is planned to enroll 60 healthy subjects. The primary objective is to evaluate the safety and tolerability of multiple dosing of TQ-A3334 tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- TQ-A3334 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2023to 19 Aug 2024
- 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
- Sign the informed consent form before the study, and fully understand the study content, process and possible adverse events;
- Be able to complete the study according to the requirements of the protocol;
- Male and female subjects aged 18 to 55 years (inclusive);
- Male subjects weigh not less than 50 kg, female subjects weigh not less than 45 kg, Body Mass Index (BMI) in the range of 18 ~ 28 kg/m2 (inclusive);
- No clinically significant medical history of cardiac, hepatic, renal, gastrointestinal, neurological, respiratory, psychiatric abnormalities and metabolic abnormalities;
- Subjects (including partners) are willing to voluntarily take effective contraception within 2 weeks before screening to 6 months after the last dose of study drug.
Who cannot join
- Female subjects who are breastfeeding or plan to conceive or have a positive serum pregnancy results during the screening or study period;
- A pre-existing or current neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or musculoskeletal disease or other condition which, in the judgment of the Investigator, may have an effect on drug metabolism or safety;
- Eye diseases, including fundus lesions;
- History of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), requiring antibiotic or antiviral medication within 14 days prior to screening or during screening;
- Acute illness or concomitant medication from the screening phase until study drug administration;
- History of dysphagia or any gastrointestinal disorder that interferes with drug absorption;
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- Abnormal and clinically significant findings on vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, abdominal ultrasound, and chest radiographs during the screening period;
- Positive for HBsAg in Hepatitis B, Hepatitis C, Syphilis, and Human Immunodeficiency Virus (HIV) antigen/antibody;
- Have taken any medication that can alter liver drug enzyme activity within 28 days prior to screening;
- Received immunoglobulin or blood product therapy within 30 days prior to screening;
- Have taken an investigational drug or participated in a clinical trial of any drug within 3 months prior to screening;
- Have taken Any prescription, over-the-counter, vitamin product, or herbal medication within 2 weeks prior to screening;
- Use of any systemic cytotoxic or systemic immunosuppressive drug within 6 months prior to screening or during the study period, or use of any localized cytotoxic or localized immunosuppressive drug within 30 days or 5 half-lives, whichever is longer, prior to screening or during the study period;
- Have undergone surgery within 4 weeks prior to screening or who plan to undergo surgery during the study period;
- Have lost blood or donated more than 400 mL of blood within 2 months prior to screening;
- Potential blood collection difficulties, history of needle and blood sickness;
- Having any clear history of drug or food allergy, especially to ingredients similar to those of the study drug;
- Those who smoked more than 5 cigarettes/day or used an equivalent amount of nicotine or nicotine-containing products within 3 months prior to screening, or who were unable to discontinue the use of any tobacco-based products during the trial;
- Those who have a history of chronic alcohol abuse or who have consumed more than 14 units of alcohol per week within 3 months prior to screening or who are unable to abstain from alcohol for the duration of the test or who have a positive breathalyzer test for alcohol;
- Those with a history of drug abuse or a positive urine drug screen;
- Those who can not avoid xanthine-rich beverages or foods or other factors that may affect drug absorption, distribution, metabolism, excretion, etc., from at least 1 day prior to study dosing until the end of the study;
- Subjects who, in the opinion of the investigator, have other factors that were unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TQ-A3334 Tablet After Multiple Doses in Healthy Adult Subjects
This study is a randomized, double-blind, placebo-controlled Phase I clinical study of TQ-A3334 tablets in adult healthy subjects, and the trial is planned to enroll 60 healthy subjects.
The primary objective is to evaluate the safety and tolerability of multiple dosing of TQ-A3334 tablets in healthy subjects.
- Conditions
- Hepatitis B
- Being tested
- TQ-A3334 tablets, TQ-A3334 placebo tablets
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-A3334 tabletsDrug
TQ-A3334 tablet is a Toll like receptor 7 (TLR7) agonist.
TQ-A3334 placebo tabletsDrug
TQ-A3334 placebo tablet is a placebo that has no effect on TLR7.
| Study group | Role | What they receive |
|---|---|---|
| TQ-A3334 tablets (once a day) | Experimental | TQ-A3334 tablets, administered once a day. Receives: Drug: TQ-A3334 tablets |
| TQ-A3334 placebo tablets (once a day) | Placebo comparator | TQ-A3334 placebo tablets, administered once a day. Receives: Drug: TQ-A3334 placebo tablets |
| TQ-A3334 tablets (every other day) | Experimental | TQ-A3334 tablets, administered once every other day. Receives: Drug: TQ-A3334 tablets |
| TQ-A3334 placebo tablets (every other day) | Placebo comparator | TQ-A3334 placebo tablets, administered once every other day. Receives: Drug: TQ-A3334 placebo tablets |
| TQ-A3334 tablets (every three days) | Experimental | TQ-A3334 tablets, administered once every three days. Receives: Drug: TQ-A3334 tablets |
| TQ-A3334 placebo tablets (every three days) | Placebo comparator | TQ-A3334 placebo tablets, administered once every three days. Receives: Drug: TQ-A3334 placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE)
Incidence of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: From patient enrollment to withdrawal, estimated to be around 1 month.
Severity of adverse events (AE)
Severity of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: From patient enrollment to withdrawal, estimated to be around 1 month.
Incidence of serious adverse events (SAE)
Incidence of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: From patient enrollment to withdrawal, estimated to be around 1 month.
Severity of serious adverse events (SAE)
Severity of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: From patient enrollment to withdrawal, estimated to be around 1 month.
Tolerability after drug administration
Tolerability is evaluated by the number of participants with abnormal laboratory examinations, vital signs, physical examination, electrocardiogram.
Measured: From patient enrollment to withdrawal, estimated to be around 1 month.
Secondary outcomes (24)
Peak Time (Tmax)
The time required to reach the highest concentration (peak drug concentration) on the human blood concentration curve after administration.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Peak concentration (Cmax)
The highest blood drug concentration achieved after administration.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration-area under time curve (AUC0-24)
The area under the plasma concentration-time curve from the beginning of the first administration to 24 hours.
Measured: From 60 minutes before administration on Day 1 to 24 hours after the last administration.
Plasma concentration-area under time curve (AUC0-24)
The area under the plasma concentration-time curve from the beginning of the first administration to the last measurable concentration point.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration-area under time curve (AUC0-∞)
Extrapolated from the first administration to the area under the plasma concentration-time curve to infinity.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Apparent volume of distribution (Vd/F)
The ratio of the drug dosage in the body to the blood drug concentration when the drug reaches dynamic equilibrium in the body.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Clearance (CL/F)
Ratio of drug clearance rate to administration concentration.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Elimination half-life time (t1/2)
The time it takes to reduce the concentration of drugs in the blood by half
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Time of maximum concentration under steady state (Tmax,ss)
Time required to reach steady-state peak concentration after administration.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Maximum concentration under steady state (Cmax, ss)
The highest blood drug concentration that occurs after reaching steady state.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Minimum concentration under steady state (Cmin, ss)
The lowest blood drug concentration that occurs after reaching steady state.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration area under steady-state time curve (AUCss)
The area under the plasma concentration-time curve of the steady state.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Accumulation Index (Rac)
The ratio of steady-state blood drug concentration to blood drug concentration after the first administration.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Degree of fluctuation (DF)
The ratio of the difference between the maximum steady-state blood drug concentration and the minimum steady-state blood drug concentration to the average steady-state blood drug concentration.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-α concentration (IFN-α)
The change of subjects' blood IFN-α concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-stimulated gene concentration (ISG)
The change of subjects' blood ISG concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-gamma concentration (IFN-γ)
The change of subjects' blood IFN-γ concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Tumor Necrosis Factor-α concentration (TNF-α)
The change of subjects' blood TNF-α concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interleukin-6 concentration (IL-6)
The change of subjects' blood IL-6 concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interleukin-2 concentration (IL-2)
The change of subjects' blood IL-2 concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Monocyte Chemotactic Protein 1 concentration (MCP-1)
The change of subjects' blood MCP-1 concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-inducible protein-10 concentration (IP-10)
The change of subjects' blood IP-10 concentration from baseline.
Measured: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
QT/QT interval
Level of change in QT/QT interval to evaluate the drug cardiotoxicity.
Measured: From 30 minutes before administration on Day 1 to 48 hours after the last administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start26 Dec 2023
- Primary completion24 Jun 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160895
- Sponsor's protocol ID
- TQ-A3334-I-04
- Status last verified
- Oct 2024
- First submitted
- 30 Nov 2023
- Last updated
- 30 Oct 2024
- 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TQ-A3334 Tablet After Multiple Doses in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06160895
- Acronym / sponsor ID
- TQ-A3334-I-04
- Conditions
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 7 Dec 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.
This study is a randomized, double-blind, placebo-controlled Phase I clinical study of TQ-A3334 tablets in adult healthy subjects, and the trial is planned to enroll 60 healthy subjects.
The primary objective is to evaluate the safety and tolerability of multiple dosing of TQ-A3334 tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TQ-A3334 tablets (once a day) | Experimental | Drug: TQ-A3334 tabletsTQ-A3334 tablets, administered once a day. |
| TQ-A3334 placebo tablets (once a day) | Placebo comparator | Drug: TQ-A3334 placebo tabletsTQ-A3334 placebo tablets, administered once a day. |
| TQ-A3334 tablets (every other day) | Experimental | Drug: TQ-A3334 tabletsTQ-A3334 tablets, administered once every other day. |
| TQ-A3334 placebo tablets (every other day) | Placebo comparator | Drug: TQ-A3334 placebo tabletsTQ-A3334 placebo tablets, administered once every other day. |
| TQ-A3334 tablets (every three days) | Experimental | Drug: TQ-A3334 tabletsTQ-A3334 tablets, administered once every three days. |
| TQ-A3334 placebo tablets (every three days) | Placebo comparator | Drug: TQ-A3334 placebo tabletsTQ-A3334 placebo tablets, administered once every three days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent form before the study, and fully understand the study content, process and possible adverse events;
- Be able to complete the study according to the requirements of the protocol;
- Male and female subjects aged 18 to 55 years (inclusive);
- Male subjects weigh not less than 50 kg, female subjects weigh not less than 45 kg, Body Mass Index (BMI) in the range of 18 ~ 28 kg/m2 (inclusive);
- No clinically significant medical history of cardiac, hepatic, renal, gastrointestinal, neurological, respiratory, psychiatric abnormalities and metabolic abnormalities;
Key exclusion criteria (22 listed)
- Female subjects who are breastfeeding or plan to conceive or have a positive serum pregnancy results during the screening or study period;
- A pre-existing or current neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or musculoskeletal disease or other condition which, in the judgment of the Investigator, may have an effect on drug metabolism or safety;
- Eye diseases, including fundus lesions;
- History of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), requiring antibiotic or antiviral medication within 14 days prior to screening or during screening;
- Acute illness or concomitant medication from the screening phase until study drug administration;
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 |
|---|---|---|
| TQ-A3334 tabletsTQ-A3334 tablet is a Toll like receptor 7 (TLR7) agonist. | Drug | TQ-A3334 tablets (every other day), TQ-A3334 tablets (every three days), TQ-A3334 tablets (once a day) |
| TQ-A3334 placebo tabletsTQ-A3334 placebo tablet is a placebo that has no effect on TLR7. | Drug | TQ-A3334 placebo tablets (every other day), TQ-A3334 placebo tablets (every three days), TQ-A3334 placebo tablets (once a day) |
Primary outcome
Incidence of adverse events (AE)
Time frame: From patient enrollment to withdrawal, estimated to be around 1 month.
Incidence of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Severity of adverse events (AE)
Time frame: From patient enrollment to withdrawal, estimated to be around 1 month.
Severity of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Incidence of serious adverse events (SAE)
Time frame: From patient enrollment to withdrawal, estimated to be around 1 month.
Incidence of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Severity of serious adverse events (SAE)
Time frame: From patient enrollment to withdrawal, estimated to be around 1 month.
Severity of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Tolerability after drug administration
Time frame: From patient enrollment to withdrawal, estimated to be around 1 month.
Tolerability is evaluated by the number of participants with abnormal laboratory examinations, vital signs, physical examination, electrocardiogram.
24 secondary outcomes
Peak Time (Tmax)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Peak concentration (Cmax)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration-area under time curve (AUC0-24)
Time frame: From 60 minutes before administration on Day 1 to 24 hours after the last administration.
Plasma concentration-area under time curve (AUC0-24)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration-area under time curve (AUC0-∞)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Apparent volume of distribution (Vd/F)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Clearance (CL/F)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Elimination half-life time (t1/2)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Time of maximum concentration under steady state (Tmax,ss)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Maximum concentration under steady state (Cmax, ss)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Minimum concentration under steady state (Cmin, ss)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration at steady state (Cav, SS)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Plasma concentration area under steady-state time curve (AUCss)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Accumulation Index (Rac)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Degree of fluctuation (DF)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-α concentration (IFN-α)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-stimulated gene concentration (ISG)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-gamma concentration (IFN-γ)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Tumor Necrosis Factor-α concentration (TNF-α)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interleukin-6 concentration (IL-6)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interleukin-2 concentration (IL-2)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Monocyte Chemotactic Protein 1 concentration (MCP-1)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
Interferon-inducible protein-10 concentration (IP-10)
Time frame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
QT/QT interval
Time frame: From 30 minutes before administration on Day 1 to 48 hours after the last administration.
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 30 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQ-A3334 tablets in people with Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 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 30 Oct 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?
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?
Incidence of adverse events (AE) (time frame: From patient enrollment to withdrawal, estimated to be around 1 month.). 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 30 Oct 2024.