HBV InfectionNCT07088133
Clinical Trials of the Hepatitis B Sandwich Combination Therapy for Treating Patients Infected With Hepatitis B Virus
A study testing NA(s)+HT-102+FD-001 in people with HBV Infection and HCC - Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.
Trial summary
Primary objective: The main objective of this study is to assess the efficacy and safety of a sandwich combination therapy in patients who were infected with HBV or have undergone surgery for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HBV Infection, HCC - Hepatocellular Carcinoma
- What is being tested?
- NA(s)+HT-102+FD-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Aug 2026
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 weeks and ≤70 years, with an expected survival time of more than 12 months;
- HCC subjects who have undergone radical surgery or ablation therapy, and no residual tumor lesions in the liver (R0 resection) were found in the postoperative review, and the postoperative pathological specimens confirmed that they were primary liver cancer and had evidence of chronic hepatitis, no evidence of extrahepatic metastasis, and did not require postoperative adjuvant therapy for low- and medium-risk subjects;
- Barcelona Clinic Liver Cancer (BCLC) stage 0 or A; Child-Pugh liver function grade A during the screening period, ECOG score 0;
- No imaging evidence of invasion of the main portal vein branches; Clinically diagnosed with chronic hepatitis B (serum HBsAg positive ≥6 months);
- Understand and are willing to sign the informed consent form, and are willing to comply with all research procedures specified in this study;
- Females of childbearing age have negative blood pregnancy tests, and subjects of childbearing age (including male subjects) have no pregnancy plans in the next 3 months and voluntarily take effective contraceptive measures;
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- Have received antiviral treatment with nucleoside (acid) analogs such as tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) or entecavir (ETV) for at least one year, and have received stable treatment with nucleoside (acid) analogs for ≥2 months during the screening period, and agree to continue using them during the study. For subjects who have previously used non-first-line nucleoside (acid) analogs such as lamivudine/adefovir/telbivudine, they agree to switch to first-line ETV/TAF/TDF/TMF and continue to use;
- HBV DNA <2000 copies/ml or 200 IU/ml at screening; HBsAg >10IU/ml and <3000 IU/ml;
- With adequate organ and bone marrow function, laboratory test values meet the following requirements:
- Routine blood test: absolute neutrophil count (ANC) ≥1.5×109 /L; platelet count (PLT) ≥90×109 /L; hemoglobin content (HGB) ≥90g/L;
- Liver function: serum albumin >35g/L; serum total bilirubin (TBIL) ≤2.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤10.0×ULN; alkaline phosphatase (ALP) ≤2.5×ULN;
- Coagulation function: international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. If the subject is taking anticoagulant therapy such as warfarin or heparin, it is necessary to ensure that the protocol requirements are met when the drug is stopped or not used;
- Urinalysis: urine protein negative or 24-hour urine protein quantitative ≤ ULN. Screening urine protein 1+ can be further confirmed by rechecking urine routine, and 24-hour urine protein quantitative test can be performed if necessary;
- Electrolytes are normal or normal after treatment or are judged by the researcher to be abnormal and have no clinical significance;
- Creatinine clearance (Ccr) >50 mL/(min·1.73m2)
Who cannot join
- Liver transplant or liver transplant candidate; previous or current diagnosis of psychiatric illness or major depression;
- Other malignancies, except for carcinoma in situ of the cervix and/or non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [breast cancer in situ], and T1 [tumor invading the lamina propria]). Any cancer that has been effectively treated for more than 3 years before participating in the study is allowed;
- Those with clinical symptoms of brain metastases, or other evidence that the subjects' brain metastases have not been controlled, and/or meningeal metastases, are judged by the researchers to be unsuitable for inclusion;
- Past or current ascites, esophageal or gastric varicose bleeding caused by portal hypertension, hepatorenal syndrome, hepatic encephalopathy or liver failure, suspected cirrhosis or compensated cirrhosis, etc.;
- Liver diseases caused by other reasons, including chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatolenticular degeneration and hemochromatosis;
- Interferon or pegylated interferon treatment or other strong immunomodulators such as adrenocortical hormone, thymosin a1, thymosin 5 peptide, etc. were used within 12 weeks before the first use of the study drug, or interferon or pegylated interferon treatment or other strong immunomodulators such as adrenocortical hormone, thymosin a1, thymosin 5 peptide, etc. are planned to be used during the trial;
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- Immunosuppressants used within 6 months before the first use of the study drug; corticosteroids used for 1 week or more within 6 months before the first use of the study drug (except topical or inhaled corticosteroids);
- Positive hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibodies or human immunodeficiency virus (HIV) antibodies;
- A history of clinically significant cardiovascular disease, including but not limited to: myocardial infarction, uncontrolled angina pectoris, viral myocarditis, stroke or other grade 3 or above cardiovascular and cerebrovascular events within 6 months before the first administration of this study drug; any supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention, left ventricular ejection fraction (LVEF) <50%, congestive heart failure of New York Heart Association (NYHA) heart function class III or IV, uncontrolled hypertension [systolic blood pressure (SBP) ≥160mmHg and/or diastolic blood pressure (DBP) ≥100mmHg after standard treatment or history of hypertensive crisis or hypertensive encephalopathy];
- Any life-threatening bleeding event in the past 3 months, including the need for transfusion, surgery or local treatment, and continuous drug treatment;
- Those who are known or may be allergic to HT-102 or FD-001 and its excipients; those who have a known history of allergy to hepatitis B vaccination;
- Participated in another clinical trial of a study drug or biological agent within 30 days or 5 half-lives before the first use of the study drug;
- Pregnant or breastfeeding women; those who the investigator believes are not suitable for participation in this trial due to other reasons;
- Active autoimmune diseases Patients with active autoimmune diseases or known history of autoimmune diseases who require systemic hormone or immunosuppressant treatment, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, Wegener's granulomatosis, Sjögren's syndrome, inflammatory bowel disease, multiple sclerosis, myasthenia gravis, myositis, autoimmune hepatitis, vasculitis, immune thrombocytopenic purpura, autoimmune hemolytic anemia and glomerulonephritis. Excluded: Subjects with endocrine diseases that can be controlled by HRT (such as hypothyroidism, type 1 diabetes, etc.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Primary objective: The main objective of this study is to assess the efficacy and safety of a sandwich combination therapy in patients who were infected with HBV or have undergone surgery for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). The primary efficacy endpoints are HBsAg seroconversion rate (HBsAg disappearance and HBsAb appearance), and HCC recurrence rate at week 49. Secondary Objective: To evaluate the safety of the HBV sandwich combination therapy through various safety indicators. Safety Indicators as follows: 1) Vital Signs: Monitoring systolic and diastolic blood pressure, pulse, respiration, and body temperature; 2) Physical Examination: Comprehensive physical assessments during the study; 3) 12-lead Electrocardiogram: Conducted to monitor cardiac health; 4) Clinical Laboratory Tests: Including blood routine, urine routine, blood biochemistry (focusing on liver and kidney function), coagulation function; 5) Injection Site Reactions: Monitoring for any local adverse effects from injections; 6) Adverse Events (AEs) and Serious Adverse Events (SAEs): Documentation of any AEs or SAEs occurring during treatment.
- Study Design: This study comprises three distinct stages:
- Screening Period (Weeks -4 to -1): 1) Informed consent will be obtained from participants; 2) Collect baseline data and perform various assessments which include: a) 12-lead ECG; b) Infectious disease screening; c) Blood biochemistry, routine blood, urine routine, coagulation function; d) Blood pregnancy test (for female subjects); e) Hepatitis B virus and serology examination; f) Antinuclear antibody testing; g) Imaging examinations.
- Treatment Period (Weeks 1 to 25): 1) Patients will receive ongoing nucleoside analogue treatment (NAs) throughout this stage; 2) Administer subcutaneous injections of the HBV monoclonal antibody HT-102 weekly for a total of 4 weeks (300 mg each time); 3) After treatment with HT-102, HBV serological and virological assessments will occur; 4) If serum HBsAg is below 10 IU/mL, proceed with therapeutic hepatitis B vaccine FD-001 (60 µg each time) every 4 weeks for a total of 6 doses; 5) If HBsAg is not below 10 IU/mL post HT-102, participants will enter the follow-up period directly.
- Follow-up Phase (Weeks 25 to 49): 1) Continue with original nucleoside analogue treatment for HBV; 2) Conduct follow-up visits every 12 weeks; 3) Each visit will involve recording vital signs, conducting physical examinations, ECG, laboratory tests (as noted in safety indicators), and testing for HBV and immunological parameters.
Read more
- End of Study:
The study concludes once the follow-up of the last enrolled subject is completed, analyzing the collected data to evaluate efficacy and safety endpoints.
- Note: Careful monitoring and adherence to protocols will be maintained to ensure participant safety and integrity of study data.
- Conditions
- HBV Infection, HCC - Hepatocellular Carcinoma
- Being tested
- NA(s)+HT-102+FD-001
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA(s)+HT-102+FD-001Drug
Nucleos(t)ide analogues will be administrated throughout the entire treatment course; Patients will be injected with HT-102 once in Day1 (Week1), Day8 (Week2), Day15 (Week3), Day22 (Week4); Patients will be injected with FD-001 once in Day29 (Week5), Day57 (Week9), Day85 (Week13), Day113 (Week17), Day141 (Week21), Day169 (Week25) after confirmed reduction of serum HBsAg to below 10 IU/mL.
| Study group | Role | What they receive |
|---|---|---|
| NA(s)+HT-102+FD-001 | Experimental | Not described Receives: Drug: NA(s)+HT-102+FD-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive convention rate of HBsAb
evaluate the seroconversion rate of HBsAg (defined as the loss of HBsAg with the concurrent appearance of anti-HBs antibodies).
Measured: through study completion, an average of 49 weeks
Secondary outcomes (10)
Proportion of subjects with ≥ 0.5 log or ≥1 log reduction in serum HBsAg levels from baseline
to evaluate the efficacy of NA(s)+HT-102+FD-001
Measured: week4, 13, 25, 37 and 49 after administraton
HBsAg changes
to evaluate the efficacy of NA(s)+HT-102+FD-001
Measured: week4, 13, 25, 37 and 49 after administraton.
HBsAg clearance rate
HBsAg clearance rate defined as undetectable HBsAg or HBsAg below 10 IU/mL
Measured: week4, 13, 25 and 37 after administraton.
HBsAg seroconversion rate
HBsAg seroconversion rate defined as loss of HBsAg with concurrent development of HBsAb
Measured: week4, 13, 25, 37 and 49 after administration
HBeAg seroconversion rate
HBeAg seroconversion rate defined as disappearance of HBeAg with concurrent appearance of HBeAb
Measured: week4, 13, 25, 37 and 49 after administration
HBeAg clearance rate
HBeAg clearance rate defined as undetectable HBeAg or HBeAg below 10 IU/mL
Measured: weeks 4, 13, 25, 37 and 49
Time from initiation of HT-102 administration to achievement of HBsAg clearance
to evaluate the efficacy of NA(s)+HT-102+FD-001
Measured: through study completion, an average of 49 weeks
Time from initiation of HT-102 administration to achievement of HBsAg seroconversion.
to evaluate the efficacy of NA(s)+HT-102+FD-001
Measured: through study completion, an average of 49 weeks
HBsAb change
to evaluate the efficacy of NA(s)+HT-102+FD-001
Measured: week4, 13, 25, 37 and 49 after administration
Changes from baseline in other HBV-related biomarkers including HBV DNA, HBeAg, anti-HBe (HBeAb), HBcAg, anti-HBc (HBcAb), and liver function parameters (ALT and AST).
to evaluate the efficacy of NA(s)+HT-102+FD-001
Measured: week4, 13, 25, 37 and 49 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088133
- Sponsor's protocol ID
- B2025-250R2
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 28 Jul 2025
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials of the Hepatitis B Sandwich Combination Therapy for Treating Patients Infected With Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT07088133
- Acronym / sponsor ID
- B2025-250R2
- Conditions
- HBV Infection, HCC - Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 28 Jul 2025 (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.
- Primary objective: The main objective of this study is to assess the efficacy and safety of a sandwich combination therapy in patients who were infected with HBV or have undergone surgery for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). The primary efficacy endpoints are HBsAg seroconversion rate (HBsAg disappearance and HBsAb appearance), and HCC recurrence rate at week 49. Secondary Objective: To evaluate the safety of the HBV sandwich combination therapy through various safety indicators. Safety Indicators as follows: 1) Vital Signs: Monitoring systolic and diastolic blood pressure, pulse, respiration, and body temperature; 2) Physical Examination: Comprehensive physical assessments during the study; 3) 12-lead Electrocardiogram: Conducted to monitor cardiac health; 4) Clinical Laboratory Tests: Including blood routine, urine routine, blood biochemistry (focusing on liver and kidney function), coagulation function; 5) Injection Site Reactions: Monitoring for any local adverse effects from injections; 6) Adverse Events (AEs) and Serious Adverse Events (SAEs): Documentation of any AEs or SAEs occurring during treatment.
- Study Design: This study comprises three distinct stages:
- Screening Period (Weeks -4 to -1): 1) Informed consent will be obtained from participants; 2) Collect baseline data and perform various assessments which include: a) 12-lead ECG; b) Infectious disease screening; c) Blood biochemistry, routine blood, urine routine, coagulation function; d) Blood pregnancy test (for female subjects); e) Hepatitis B virus and serology examination; f) Antinuclear antibody testing; g) Imaging examinations.
- Treatment Period (Weeks 1 to 25): 1) Patients will receive ongoing nucleoside analogue treatment (NAs) throughout this stage; 2) Administer subcutaneous injections of the HBV monoclonal antibody HT-102 weekly for a total of 4 weeks (300 mg each time); 3) After treatment with HT-102, HBV serological and virological assessments will occur; 4) If serum HBsAg is below 10 IU/mL, proceed with therapeutic hepatitis B vaccine FD-001 (60 µg each time) every 4 weeks for a total of 6 doses; 5) If HBsAg is not below 10 IU/mL post HT-102, participants will enter the follow-up period directly.
- Follow-up Phase (Weeks 25 to 49): 1) Continue with original nucleoside analogue treatment for HBV; 2) Conduct follow-up visits every 12 weeks; 3) Each visit will involve recording vital signs, conducting physical examinations, ECG, laboratory tests (as noted in safety indicators), and testing for HBV and immunological parameters.
- End of Study:
The study concludes once the follow-up of the last enrolled subject is completed, analyzing the collected data to evaluate efficacy and safety endpoints.
- Note: Careful monitoring and adherence to protocols will be maintained to ensure participant safety and integrity of study data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NA(s)+HT-102+FD-001 | Experimental | Drug: NA(s)+HT-102+FD-001 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female subjects aged ≥18 weeks and ≤70 years, with an expected survival time of more than 12 months;
- HCC subjects who have undergone radical surgery or ablation therapy, and no residual tumor lesions in the liver (R0 resection) were found in the postoperative review, and the postoperative pathological specimens confirmed that they were primary liver cancer and had evidence of chronic hepatitis, no evidence of extrahepatic metastasis, and did not require postoperative adjuvant therapy for low- and medium-risk subjects;
- Barcelona Clinic Liver Cancer (BCLC) stage 0 or A; Child-Pugh liver function grade A during the screening period, ECOG score 0;
- No imaging evidence of invasion of the main portal vein branches; Clinically diagnosed with chronic hepatitis B (serum HBsAg positive ≥6 months);
- Understand and are willing to sign the informed consent form, and are willing to comply with all research procedures specified in this study;
Key exclusion criteria (14 listed)
- Liver transplant or liver transplant candidate; previous or current diagnosis of psychiatric illness or major depression;
- Other malignancies, except for carcinoma in situ of the cervix and/or non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [breast cancer in situ], and T1 [tumor invading the lamina propria]). Any cancer that has been effectively treated for more than 3 years before participating in the study is allowed;
- Those with clinical symptoms of brain metastases, or other evidence that the subjects' brain metastases have not been controlled, and/or meningeal metastases, are judged by the researchers to be unsuitable for inclusion;
- Past or current ascites, esophageal or gastric varicose bleeding caused by portal hypertension, hepatorenal syndrome, hepatic encephalopathy or liver failure, suspected cirrhosis or compensated cirrhosis, etc.;
- Liver diseases caused by other reasons, including chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatolenticular degeneration and hemochromatosis;
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 |
|---|---|---|
| NA(s)+HT-102+FD-001Nucleos(t)ide analogues will be administrated throughout the entire treatment course; Patients will be injected with HT-102 once in Day1 (Week1), Day8 (Week2), Day15 (Week3), Day22 (Week4); Patients will be injected with FD-001 once in Day29 (Week5), Day57 (Week9), Day85 (Week13), Day113 (Week17), Day141 (Week21), Day169 (Week25) after confirmed reduction of serum HBsAg to below 10 IU/mL. | Drug | NA(s)+HT-102+FD-001 |
Primary outcome
Positive convention rate of HBsAb
Time frame: through study completion, an average of 49 weeks
evaluate the seroconversion rate of HBsAg (defined as the loss of HBsAg with the concurrent appearance of anti-HBs antibodies).
10 secondary outcomes
Proportion of subjects with ≥ 0.5 log or ≥1 log reduction in serum HBsAg levels from baseline
Time frame: week4, 13, 25, 37 and 49 after administraton
HBsAg changes
Time frame: week4, 13, 25, 37 and 49 after administraton.
HBsAg clearance rate
Time frame: week4, 13, 25 and 37 after administraton.
HBsAg seroconversion rate
Time frame: week4, 13, 25, 37 and 49 after administration
HBeAg seroconversion rate
Time frame: week4, 13, 25, 37 and 49 after administration
HBeAg clearance rate
Time frame: weeks 4, 13, 25, 37 and 49
Time from initiation of HT-102 administration to achievement of HBsAg clearance
Time frame: through study completion, an average of 49 weeks
Time from initiation of HT-102 administration to achievement of HBsAg seroconversion.
Time frame: through study completion, an average of 49 weeks
HBsAb change
Time frame: week4, 13, 25, 37 and 49 after administration
Changes from baseline in other HBV-related biomarkers including HBV DNA, HBeAg, anti-HBe (HBeAb), HBcAg, anti-HBc (HBcAb), and liver function parameters (ALT and AST).
Time frame: week4, 13, 25, 37 and 49 after 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 28 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing NA(s)+HT-102+FD-001 in people with HBV Infection and HCC - Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.
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 15 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: opening soon, as of the sponsor's last update on 28 Jul 2025. 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.
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 GAO, Doctor (086-021-64041990-2047, gaoqiang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive convention rate of HBsAb (time frame: through study completion, an average of 49 weeks). 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 28 Jul 2025.