Hepatic InsufficiencyPhase 4NCT07345689
A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations
A Phase 4 study testing Anaprazole Sodium enteric-coated tablet in people with Hepatic Insufficiency and Renal Insufficiency, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency, Renal Insufficiency, Elderly
- What is being tested?
- Anaprazole Sodium enteric-coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form before any study-related activities commence, demonstrate an understanding of the trial procedures and methodology, and be willing to strictly adhere to the clinical trial protocol for study completion;
- Subjects (including their partners) must agree to have no plans for conception from screening until 6 months after the last dose of the investigational drug and to voluntarily practice effective contraception during this period;
- Aged 18 to 70 years (inclusive) at the time of signing informed consent, either male or female. For the elderly group, subjects must be aged 65 years or older (inclusive);
- Body mass index (BMI) between 18 and 32 kg/m² (inclusive);
- Subjects in the healthy group should be matched as closely as possible to those in the hepatic impairment, renal impairment, and elderly groups in terms of gender and weight, and additionally matched for age with the hepatic and renal impairment groups;
- Subjects in the hepatic impairment group must also meet all of the following additional criteria:
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- Subjects with chronic liver injury due to primary liver diseases (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.), classified as Child-Pugh Grade B hepatic insufficiency; Clinically diagnosed cirrhosis; eGFR > 59 mL/min; Subjects are either those with a stable concomitant medication regimen (for hepatic impairment/complications/other diseases) for ≥2 weeks pre-dose not requiring anticipated adjustment (excluding, e.g., diuretics/insulin), or those not on such medications;
- Subjects in the renal impairment group must also meet all of the following additional criteria:
- Diagnosed with chronic kidney disease (CKD), defined as the presence of any marker of kidney damage or GFR < 60 mL/min for more than 3 months (evidence may include outpatient records, inpatient records, or laboratory reports); GFR must meet the following criteria: Moderate renal impairment (CKD Stage 3): 30-59 mL/min (inclusive); Severe renal impairment (CKD Stage 4): 15-29 mL/min (inclusive); Note: Staging will be determined solely based on the second scheduled GFR measurement during the screening period; Renal function must be stable, defined as meeting either of the following criteria based on two GFR measurements taken prior to dosing (with at least a 3-day interval between measurements): Both results fall within the same CKD stage; or the fluctuation between the two GFR results is <10% (calculated as: [(Second result - First result) / First result] × 100%).
Who cannot join
- Subjects with a history of hypersensitivity or allergic constitution (including severe drug allergies or drug hypersensitivity reactions), or with a known allergy to the investigational drug or any of its excipients;
- QTcF (male) > 470 ms, QTcF (female) > 480 ms;
- Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive therapy. This criterion does not apply to subjects in the healthy group;
- History of dysphagia or any gastrointestinal disorder that may affect drug absorption, including frequent nausea or vomiting due to any etiology;
- History of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening;
- Receipt of any vaccine within 14 days prior to screening, or intention to receive any vaccination during the course of the study;
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- Donation or loss of blood ≥ 400 mL within 3 months prior to screening, or intention to donate blood during the study;
- Use of moderate or strong CYP3A4 inhibitors/inducers within 2 weeks prior to screening, or planned concomitant use during the study; or use of CYP3A4-sensitive substrates within 2 weeks prior to screening or planned use during the study;
- Use of proton pump inhibitors (PPIs, e.g., rabeprazole, pantoprazole, esomeprazole) within 2 weeks prior to screening or planned concomitant use during the study; medications known to affect serum creatinine clearance (e.g., calcium dobesilate, trimethoprim/sulfamethoxazole, cimetidine); drugs prone to cause liver injury (e.g., non steroidal anti inflammatory drugs, antibiotics, antituberculosis agents, antifungals, glucocorticoids); or drugs with high plasma protein binding (e.g., warfarin, dicoumarol, diazepam, phenylbutazone, digitoxin);
- Consumption of special diets (including pitaya, mango, pomelo, and/or xanthine containing foods such as chocolate) within 2 weeks prior to dosing, and/or habitual excessive intake of tea, coffee, grapefruit/grapefruit juice, or caffeinated beverages (average >8 cups per day, 200 mL per cup);
- History of excessive alcohol consumption, defined as >14 units per week on average, within the 3 months preceding screening (where 1 alcohol unit equals 360 mL of beer, 45 mL of 40% distilled spirits, or 150 mL of wine);
- Positive result on alcohol breath test or urine drug screening at screening;
- Average cigarette consumption of ≥10 cigarettes per day within 3 months prior to screening;
- History of drug abuse or substance misuse;
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test;
- Intolerance to venipuncture or history of needle/phobia syncope;
- Use of any investigational drug within 3 months prior to screening or planned participation in another clinical trial during this study;
- Other conditions deemed by the investigator to compromise the subject's suitability for the study;
- Healthy Subjects will be excluded if they meet any of the following criteria:
- History of hepatic impairment or renal impairment;
- Any clinically significant active or chronic disease affecting major organ systems (e.g., circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems) at screening, or any other medical condition that could potentially confound the interpretation of study outcomes;
- Clinically significant abnormalities (as judged by the investigator) in physical examination, vital signs, laboratory tests, 12 lead ECG, abdominal ultrasound, or chest X ray;
- Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen/antibody, or syphilis antibody;
- Administration of any prescription medication, non prescription drug, vitamin supplement, or herbal preparation within 14 days prior to screening;
- Subjects in the hepatic impairment group will be excluded if they meet any of the following criteria:
- Subjects who present with any of the following conditions and are deemed by the investigator as unsuitable for this study will be excluded:
- Prior liver transplantation; Diseases such as biliary cirrhosis or extrahepatic biliary obstruction;
- Diagnosis of liver cancer or other malignant tumors, with the following exceptions:
- Certain completely cured cancers after surgical resection, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; Liver cancer patients who have received radical therapy with no recurrence; Liver cancer patients classified as BCLC stage 0. Acute liver failure; History of esophageal or gastric variceal bleeding within 3 months prior to screening;
- Laboratory test results at screening meeting any of the following criteria:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN);
- Absolute neutrophil count < 0.75 × 10⁹/L;
- Hemoglobin < 80 g/L;
- Alpha fetoprotein (AFP) > 100 ng/mL;
- Platelet count < 40 × 10⁹/L; or any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;
- Positive screening result for HIV antigen/antibody; Positive syphilis antibody test result with a confirmatory positive rapid plasma reagin (RPR) test;
- In addition to the primary hepatic condition, subjects will be excluded if, at screening, they present with any other severe systemic disease-including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardiovascular/cerebrovascular disorders-that in the investigator's judgment would make them unsuitable for the study;
- Subjects in the renal impairment group will be excluded if they meet any of the following criteria:
- Acute renal failure, prior kidney transplantation, or requirement for renal dialysis during the study;
- Subjects will be excluded if, in addition to chronic kidney disease and its complications, they have a history or current evidence of any other severe systemic disorder-including but not limited to significant gastrointestinal, respiratory, neurological, hematological, endocrine, oncological (except for completely resected in situ basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast), immunological, psychiatric, or cardiovascular/cerebrovascular disease-that, in the investigator's opinion, would make participation in the study inappropriate;
- ALT ≥ 2 × ULN, AST ≥ 2 × ULN; Serum total bilirubin > 1.5 × ULN; Albumin < 30 g/L; Absolute neutrophil count < 1.3 × 10⁹/L; Hemoglobin < 80 g/L; Platelet count < 100 × 10⁹/L; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;
- Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, or Left ventricular ejection fraction (LVEF) < 50% at screening;
- Positive result for HIV antigen/antibody; Positive syphilis antibody test result, with a confirmatory positive rapid plasma reagin (RPR) test;
- Elderly subjects will be excluded if they meet any of the following criteria:
- Subjects will be excluded if they have any other severe systemic disease at screening - including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, oncologic (except completely resected in situ basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast), immunologic, psychiatric, or cardiovascular/cerebrovascular disorders - and if, in the investigator's judgment, participation would be inappropriate;
- Fasting blood glucose > 7.0 mmol/L;
- ALT ≥ 1.5 × ULN, AST ≥ 1.5 × ULN; Serum total bilirubin > 1.5 × ULN; Albumin < 30 g/L; Creatinine > 1.5 × ULN; Albumin < 30 g/L; Hemoglobin < 100 g/L; Platelet count < 100 × 10⁹/L; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;
- Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen/antibody, or syphilis antibody.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Bethune Hospital of Jilin University
Changchun, Jilin
Hong Zhang, PhD, +86-13654376192, jhongzhang@qq.com
Hong Zhang, PhD
About this study
Official title: A Study to Evaluate the Pharmacokinetics and Safety of Anaprazole Sodium in Subjects With Hepatic or Renal Impairment and in Elderly Subjects
The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.
Read the detailed description
This study is a single-center, open-label, single-dose trial designed to assess the pharmacokinetics and safety of anaprazole sodium in adult subjects. The study consists of five groups: healthy volunteers, subjects with moderate hepatic impairment, subjects with moderate renal impairment, subjects with severe renal impairment, and elderly subjects. Each arm will enroll 8-12 subjects, for a total target sample size of 40-60. The overall trial schedule consists of a Screening Period (Day -14 to Day -2), a Baseline Period (Day -1), a Dosing/Study Period (Day 1 to Day 3), and a Safety Follow-up Period (Day 7). Blood samples for pharmacokinetic (PK) analysis will be collected from all subjects throughout the study. In addition, urine samples for PK assessment will be collected specifically from subjects in the healthy control group and the moderate and severe renal impairment groups.
- Conditions
- Hepatic Insufficiency, Renal Insufficiency, Elderly
- Being tested
- Anaprazole Sodium enteric-coated tablet
- 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.
Anaprazole Sodium enteric-coated tabletDrug
20 mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Healthy subjects Receives: Drug: Anaprazole Sodium enteric-coated tablet |
| Moderate hepatically impaired subjects | Experimental | Subjects with Child-Pugh B (score 7-9) at the screening visit Receives: Drug: Anaprazole Sodium enteric-coated tablet |
| Moderate renal impaired subjects | Experimental | Subjects with eGFR 30-59 mL/min at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation Receives: Drug: Anaprazole Sodium enteric-coated tablet |
| Severe renal impaired subjects | Experimental | Subjects with eGFR 15-29 mL/min at the screening visit based on the MDRD equation Receives: Drug: Anaprazole Sodium enteric-coated tablet |
| Elderly subjects | Experimental | Elderly subjects (≥65 years old) Receives: Drug: Anaprazole Sodium enteric-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax of anaprazole sodium in healthy subjects and special participant populations.
Measured: Up to 48 hours from anaprazole sodium administration
Tmax
Tmax of anaprazole sodium in healthy subjects and special participant populations.
Measured: Up to 48 hours from anaprazole sodium administration
AUC0-t
AUC0-t of anaprazole sodium in healthy subjects and special participant populations.
Measured: Up to 48 hours from anaprazole sodium administration
AUC0-∞
AUC0-∞of anaprazole sodium in healthy subjects and special participant populations.
Measured: Up to 48 hours from anaprazole sodium administration
t1/2
t1/2 of anaprazole sodium in healthy subjects and special participant populations.
Measured: Up to 48 hours from anaprazole sodium administration
CL/F
CL/F of anaprazole sodium in healthy subjects and special participant populations.
Measured: Up to 48 hours from anaprazole sodium administration
Vz/F
Vz/F of anaprazole sodium in healthy subjects and special participant populations
Measured: Up to 48 hours from anaprazole sodium administration
Secondary outcomes (1)
Number of Subjects With Adverse Events (AEs)
Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication to the end of the study.
Measured: Up to 7 days from the start of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zhang, PhD, Principal investigator, The First Bethune Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345689
- Sponsor's protocol ID
- 3571-CPK-1008
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics and Safety of Anaprazole Sodium in Subjects With Hepatic or Renal Impairment and in Elderly Subjects
- ClinicalTrials.gov ID
- NCT07345689
- Acronym / sponsor ID
- 3571-CPK-1008
- Conditions
- Hepatic Insufficiency, Renal Insufficiency, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.
Detailed description
This study is a single-center, open-label, single-dose trial designed to assess the pharmacokinetics and safety of anaprazole sodium in adult subjects. The study consists of five groups: healthy volunteers, subjects with moderate hepatic impairment, subjects with moderate renal impairment, subjects with severe renal impairment, and elderly subjects. Each arm will enroll 8-12 subjects, for a total target sample size of 40-60. The overall trial schedule consists of a Screening Period (Day -14 to Day -2), a Baseline Period (Day -1), a Dosing/Study Period (Day 1 to Day 3), and a Safety Follow-up Period (Day 7). Blood samples for pharmacokinetic (PK) analysis will be collected from all subjects throughout the study. In addition, urine samples for PK assessment will be collected specifically from subjects in the healthy control group and the moderate and severe renal impairment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Drug: Anaprazole Sodium enteric-coated tabletHealthy subjects |
| Moderate hepatically impaired subjects | Experimental | Drug: Anaprazole Sodium enteric-coated tabletSubjects with Child-Pugh B (score 7-9) at the screening visit |
| Moderate renal impaired subjects | Experimental | Drug: Anaprazole Sodium enteric-coated tabletSubjects with eGFR 30-59 mL/min at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation |
| Severe renal impaired subjects | Experimental | Drug: Anaprazole Sodium enteric-coated tabletSubjects with eGFR 15-29 mL/min at the screening visit based on the MDRD equation |
| Elderly subjects | Experimental | Drug: Anaprazole Sodium enteric-coated tabletElderly subjects (≥65 years old) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign the informed consent form before any study-related activities commence, demonstrate an understanding of the trial procedures and methodology, and be willing to strictly adhere to the clinical trial protocol for study completion;
- Subjects (including their partners) must agree to have no plans for conception from screening until 6 months after the last dose of the investigational drug and to voluntarily practice effective contraception during this period;
- Aged 18 to 70 years (inclusive) at the time of signing informed consent, either male or female. For the elderly group, subjects must be aged 65 years or older (inclusive);
- Body mass index (BMI) between 18 and 32 kg/m² (inclusive);
- Subjects in the healthy group should be matched as closely as possible to those in the hepatic impairment, renal impairment, and elderly groups in terms of gender and weight, and additionally matched for age with the hepatic and renal impairment groups;
Key exclusion criteria (48 listed)
- Subjects with a history of hypersensitivity or allergic constitution (including severe drug allergies or drug hypersensitivity reactions), or with a known allergy to the investigational drug or any of its excipients;
- QTcF (male) > 470 ms, QTcF (female) > 480 ms;
- Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive therapy. This criterion does not apply to subjects in the healthy group;
- History of dysphagia or any gastrointestinal disorder that may affect drug absorption, including frequent nausea or vomiting due to any etiology;
- History of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening;
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 |
|---|---|---|
| Anaprazole Sodium enteric-coated tablet20 mg single dose | Drug | Elderly subjects, Healthy subjects, Moderate hepatically impaired subjects, Moderate renal impaired subjects, Severe renal impaired subjects |
Primary outcome
Cmax
Time frame: Up to 48 hours from anaprazole sodium administration
Cmax of anaprazole sodium in healthy subjects and special participant populations.
Tmax
Time frame: Up to 48 hours from anaprazole sodium administration
Tmax of anaprazole sodium in healthy subjects and special participant populations.
AUC0-t
Time frame: Up to 48 hours from anaprazole sodium administration
AUC0-t of anaprazole sodium in healthy subjects and special participant populations.
AUC0-∞
Time frame: Up to 48 hours from anaprazole sodium administration
AUC0-∞of anaprazole sodium in healthy subjects and special participant populations.
t1/2
Time frame: Up to 48 hours from anaprazole sodium administration
t1/2 of anaprazole sodium in healthy subjects and special participant populations.
CL/F
Time frame: Up to 48 hours from anaprazole sodium administration
CL/F of anaprazole sodium in healthy subjects and special participant populations.
Vz/F
Time frame: Up to 48 hours from anaprazole sodium administration
Vz/F of anaprazole sodium in healthy subjects and special participant populations
1 secondary outcome
Number of Subjects With Adverse Events (AEs)
Time frame: Up to 7 days from the start of administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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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.
Hong Zhang, PhD principal investigator
The First Bethune Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anaprazole Sodium enteric-coated tablet in people with Hepatic Insufficiency and Renal Insufficiency, run by Xuanzhu Biopharmaceutical 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 9 inclusion and 48 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: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Zhang, PhD (+86-13654376192, jhongzhang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Up to 48 hours from anaprazole sodium administration). The study lists 7 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 16 Jan 2026.