Hepatic AscitesPhase 1NCT05249374
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects
A Phase 1 study testing Recombinant Human Serum Albumin and Human serum albumin in people with Hepatic Ascites, run by Beijing Protgen Biotechnology Development Co., Ltd. at 8 sites in China.
Trial summary
This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites subjects (both male and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Ascites
- What is being tested?
- Recombinant Human Serum Albumin and Human serum albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesChina
- Study dates
- 14 Oct 2021to 16 May 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to follow the experimental treatment plan and visit plan, voluntarily enroll in the group, and sign the informed consent in person;
- Age ≥18 years old and <65 years old on the day of signing the informed consent, no gender limitation; Body mass index (BMI) ranged from 18.0 kg/m2 to 29.0 kg/m2 (including boundary values);
- Patients clinically diagnosed as decompensated cirrhotic ascites with ascites grade 1-2 and serum albumin (ALB) <30 g/L confirmed by abdominal ultrasonography during screening period;
- Men and women of child-bearing age with fertility (childbearing age women including premenopausal women and 2 years after menopause women) from willing to sign a consent form began to experiment with drugs within 3 months after the last delivery effective precautions (take a condom, contraceptive sponge, contraceptive gel, diaphragm, intrauterine device, oral or injectable contraceptives, subcutaneous preparetions Agent, etc.); Women of reproductive age must have a negative pregnancy test no later than 7 days before the first investigational drug is administered.
Who cannot join
- Patients who meet any of the following criteria are not eligible for inclusion:
- Patients with malignant ascites;
- People who have a known history of allergy/allergic reaction to yeast or yeast-derived products or are allergic to any component of the study product; Patients with an allergic constitution (multiple drug or food allergy), a history of allergic to biological products, or a history of severe systemic allergic reaction caused by other reasons, and the investigator judges that they are not suitable for treatment with experimental drugs;
- The patient has the following abnormal laboratory tests:
- Bone marrow function: absolute value of neutrophils (ANC) <1.0×109/L (1000/mm3); Platelet (PLT) <20×109/L (2×104/mm3); Hemoglobin (HGB) <7.0 g/dL;Liver function: alanine aminotransferase (ALT) > 5×ULN (upper normal value); Aspartate aminotransferase (AST) > 5×ULN; Serum bilirubin (T-Bil) >3× upper normal value (ULN);Renal function: serum creatinine >2× upper normal value (ULN); Positive urine protein and ineligible to participate in the test judged by the investigator; coagulation function: prothrombin activity <40%;
- Active cardiovascular disease or history at the time of screening, or other conditions that the investigator determined were not suitable for human serum albumin therapy, including but not limited to hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg), Researchers determine drug control is good and stable condition except), severe anemia, heart disease, acute severe lung or structural heart disease, severe arrhythmia, normal blood volume (or high blood volume) of decompensated heart failure, unstable angina, nearly six months prior to screening the myocardial infarction, require drug treatment of tachycardia/slow, three degree atrioventricular block, etc.;
Show all 15Show fewer
- At the time of screening, there was a history of active metabolic system disease or other renal injury that the investigator determined was unsuitable for serum albumin treatment, including but not limited to renal/postrenal anuria, hepatorenal syndrome (HRS), chronic kidney disease, hepatitis B related nephropathy, etc.;
- Patients with the following active concurrent diseases during screening, including but not limited to, Pulmonary edema, bleeding tendency, or active bleeding disease, sustained or active infection (including active spontaneous bacterial peritonitis (SBP)), according to West - Haven classification standard diagnosis of hepatic encephalopathy grade III or IV level, portal venous tumor emboli/blood clots, circulation dysfunction after abdominal puncture, ultrasound and other imaging examination of biliary obstructive disease Disease, thyroid dysfunction (grade 3 and above according to NCI CTCAE version 5.0);
- Patients with previous history of upper gastrointestinal bleeding within 1 month or gastrointestinal bleeding within 3 months (≥2 times) or high risk of bleeding during the study as assessed by the investigator;
- Patients with active malignancies (including hepatocellular carcinoma [HCC]) at the time of screening, or with a history of malignant tumors within 5 years (except cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ and other very low-risk malignancies of cervical or breast cancer undergoing curative treatment);
- Those who have received corticosteroids or human plasma preparations (including human serum albumin preparations) within 20 days prior to the first administration of the investigational drug; Those with a history of organ transplantation; Those requiring or planning to undergo invasive tests or treatment during the study period;
- Participating in or participating in clinical trials of other new drugs or medical devices and using investigational drugs/investigational treatments within 30 days prior to screening; Prior participation in clinical trials of recombinant human serum albumin;
- HIV antibody test positive, or syphilis (defined as positive syphilis antibody test and positive retin test);
- Pregnant or lactating women;
- Other reasons that the researcher considers inappropriate to participate in this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
The First Hospital of Changsha
Changsha, Hunan, 410005
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000
Shenzhen Protgen Co., Ltd.
Shenzhen, Guangdong, 100084
Shenzhen Third People's Hospital
Shenzhen, Guangdong, 518000
Hebei Petro China Central Hospital
Shijiazhuang, Hebei, 050000
Yichun People's Hospital
Yichun, Jiangxi, 336000
Yiyang Central Hospital
Yiyang, Hunan, 413000
About this study
Official title: A Randomized, Double-blind, Active Drug-controlled, Dose-escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of r-HSA in Patients With Cirrhosis and Ascites
This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites
subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.
Read the detailed description
In this Phase Ib clinical trial, randomized, double-blind, positive-controlled, dose-increasing design was employed to enroll cirrhosis ascites patients and evaluate safety, tolerability, PK characteristics, PD characteristics and preliminary efficacy at different dose levels of recombinant human serum albumin.
Three dose groups (10 g/day, 20 g/day, 30 g/day) were set up in this study, and they were escalated from the lowest to the highest dosage. It is planned to enroll 12 subjects in each dose group, with 8 of 12 subjects in each dose group receiving the investigational product and 4 of 12 subjects receiving the comparator product intravenously once a day for 14 days or up to serum albumin ≥ 35 g/L ( whichever occurs first ), to investigate the safety, tolerability, immunogenicity, PK characteristics, PD characteristics and preliminary efficacy in repeated usage of recombinant human serum albumin.
- Conditions
- Hepatic Ascites
- Being tested
- Recombinant Human Serum Albumin, Human serum albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Serum AlbuminDrug
10 g/bottle (20%, 50 mL)
Human serum albuminDrug
10 g/bottle (20%, 50 mL)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 10 g/ bottle (20%, 50 mL) Receives: Drug: Recombinant Human Serum Albumin |
| test group | Experimental | 10 g/bottle (20%, 50 mL) Receives: Drug: Human serum albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAE
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms)., TEAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
Measured: 57 days
SAE
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms). SAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
Measured: 57 days
Secondary outcomes (11)
AUC0-last
Within 1 hour before administration of D1, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes);
If subject has completed 14 days of treatment, then:
Within 1 hour before administration of D2~D13, immediately after administration (+1 min); D14: within 1 hour before administration, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes); D15, D16, D17, D29 (±3 days), D57 (±5 days).
If the 14-day treatment has not been completed, then:
Before drug withdrawal: receive 2 PK blood sample collections within 1 hour before administration and immediately after administration (+1 min) each day; After drug withdrawal: from the day of drug withdrawal, collect PK blood samples once for 3 consecutive days.
Measured: 57 days
Pharmacokinetic characteristics
Within 1 hour before administration of D1, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes);
If subject has completed 14 days of treatment, then:
Within 1 hour before administration of D2~D13, immediately after administration (+1 min); D14: within 1 hour before administration, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes); D15, D16, D17, D29 (±3 days), D57 (±5 days).
If the 14-day treatment has not been completed, then:
Before drug withdrawal: receive 2 PK blood sample collections within 1 hour before administration and immediately after administration (+1 min) each day; After drug withdrawal: from the day of drug withdrawal, collect PK blood samples once for 3 consecutive days.
Measured: 57 day
Albumin concentration of D15
Collect blood samples on the fifteenth day and determine the albumin concentration on the fifteenth day.
Measured: 1 day
Albumin concentration of D29
Collect blood samples on the 29th day(±3 days) and determine the albumin concentration on the 29th day.
Measured: 1 day
Albumin concentration of D57
Collect blood samples on the 57th day（±5 days） and determine the albumin concentration on the 57th day.
Measured: 1 day
t1/2
Within 1 hour before administration of D1, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes);
If subject has completed 14 days of treatment, then:
Within 1 hour before administration of D2~D13, immediately after administration (+1 min); D14: within 1 hour before administration, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes); D15, D16, D17, D29 (±3 days), D57 (±5 days).
If the 14-day treatment has not been completed, then:
Before drug withdrawal: receive 2 PK blood sample collections within 1 hour before administration and immediately after administration (+1 min) each day; After drug withdrawal: from the day of drug withdrawal, collect PK blood samples once for 3 consecutive days.
Measured: 57 days
CL
Within 1 hour before administration of D1, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes);
If subject has completed 14 days of treatment, then:
Within 1 hour before administration of D2~D13, immediately after administration (+1 min); D14: within 1 hour before administration, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes); D15, D16, D17, D29 (±3 days), D57 (±5 days).
If the 14-day treatment has not been completed, then:
Before drug withdrawal: receive 2 PK blood sample collections within 1 hour before administration and immediately after administration (+1 min) each day; After drug withdrawal: from the day of drug withdrawal, collect PK blood samples once for 3 consecutive days.
Measured: 57 days
Cpost-Cpre
Calculate the ratio of serum albumin concentration to C0 at each time point, and calculate the difference of albumin concentration before and after each intravenous administration
Measured: 14 days
Plasma colloid osmotic pressure
D1 within 1 hour before administration, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes);
If the 14-day treatment cycle is completed, then:
Within 1 hour before administration of D2~D13, immediately after administration (+1 min); D14: within 1 hour before administration, immediately after administration (+1 min), 2 hours (±5 minutes), 10 hours (±30 minutes); D15, D16, D17.
If discontinuation of 14-day treatment cycle is not completed, then:
Before drug withdrawal: 2 blood samples were collected within 1 hour before each administration and immediately after the administration (+1 min); After drug withdrawal: From the day of drug withdrawal, collect PD blood samples once for 3 consecutive days.
Measured: 17 days
the Anti-Drug antibody (ADA) of rHSA
All subjects in this trial who received at least 1 intravenous dose, regardless of when they ended treatment, were required to visit D1 before intravenous administration of the investigational drug, D8, D15, D29, D57, and at the early withdrawal visit (if any). ADA blood samples were collected, and the sample collection time window was the same as the time window of the current visit. Immunogenicity was assessed by assessing the incidence and titers of anti-rHSA, if applicable.
Measured: 57 days
the Anti-Drug antibody (ADA) of HCP
All subjects in this trial who received at least 1 intravenous dose, regardless of when they ended treatment, were required to visit D1 before intravenous administration of the investigational drug, D8, D15, D29, D57, and at the early withdrawal visit (if any). ADA blood samples were collected, and the sample collection time window was the same as the time window of the current visit. Immunogenicity was assessed by assessing the incidence and titers of anti-host protein (HCP) ADAs, if applicable.
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start14 Oct 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic AscitesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Chen, Ph.D, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249374
- Sponsor's protocol ID
- rHSA 2020-2
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Drug-controlled, Dose-escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of r-HSA in Patients With Cirrhosis and Ascites
- ClinicalTrials.gov ID
- NCT05249374
- Acronym / sponsor ID
- rHSA 2020-2
- Conditions
- Hepatic Ascites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 21 Feb 2022 (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 trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites
subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.
Detailed description
In this Phase Ib clinical trial, randomized, double-blind, positive-controlled, dose-increasing design was employed to enroll cirrhosis ascites patients and evaluate safety, tolerability, PK characteristics, PD characteristics and preliminary efficacy at different dose levels of recombinant human serum albumin.
Three dose groups (10 g/day, 20 g/day, 30 g/day) were set up in this study, and they were escalated from the lowest to the highest dosage. It is planned to enroll 12 subjects in each dose group, with 8 of 12 subjects in each dose group receiving the investigational product and 4 of 12 subjects receiving the comparator product intravenously once a day for 14 days or up to serum albumin ≥ 35 g/L ( whichever occurs first ), to investigate the safety, tolerability, immunogenicity, PK characteristics, PD characteristics and preliminary efficacy in repeated usage of recombinant human serum albumin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Recombinant Human Serum Albumin10 g/ bottle (20%, 50 mL) |
| test group | Experimental | Drug: Human serum albumin10 g/bottle (20%, 50 mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agree to follow the experimental treatment plan and visit plan, voluntarily enroll in the group, and sign the informed consent in person;
- Age ≥18 years old and <65 years old on the day of signing the informed consent, no gender limitation; Body mass index (BMI) ranged from 18.0 kg/m2 to 29.0 kg/m2 (including boundary values);
- Patients clinically diagnosed as decompensated cirrhotic ascites with ascites grade 1-2 and serum albumin (ALB) <30 g/L confirmed by abdominal ultrasonography during screening period;
- Men and women of child-bearing age with fertility (childbearing age women including premenopausal women and 2 years after menopause women) from willing to sign a consent form began to experiment with drugs within 3 months after the last delivery effective precautions (take a condom, contraceptive sponge, contraceptive gel, diaphragm, intrauterine device, oral or injectable contraceptives, subcutaneous preparetions Agent, etc.); Women of reproductive age must have a negative pregnancy test no later than 7 days before the first investigational drug is administered.
Key exclusion criteria (15 listed)
- Patients with malignant ascites;
- People who have a known history of allergy/allergic reaction to yeast or yeast-derived products or are allergic to any component of the study product; Patients with an allergic constitution (multiple drug or food allergy), a history of allergic to biological products, or a history of severe systemic allergic reaction caused by other reasons, and the investigator judges that they are not suitable for treatment with experimental drugs;
- The patient has the following abnormal laboratory tests:
- Bone marrow function: absolute value of neutrophils (ANC) <1.0×109/L (1000/mm3); Platelet (PLT) <20×109/L (2×104/mm3); Hemoglobin (HGB) <7.0 g/dL;Liver function: alanine aminotransferase (ALT) > 5×ULN (upper normal value); Aspartate aminotransferase (AST) > 5×ULN; Serum bilirubin (T-Bil) >3× upper normal value (ULN);Renal function: serum creatinine >2× upper normal value (ULN); Positive urine protein and ineligible to participate in the test judged by the investigator; coagulation function: prothrombin activity <40%;
- Active cardiovascular disease or history at the time of screening, or other conditions that the investigator determined were not suitable for human serum albumin therapy, including but not limited to hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg), Researchers determine drug control is good and stable condition except), severe anemia, heart disease, acute severe lung or structural heart disease, severe arrhythmia, normal blood volume (or high blood volume) of decompensated heart failure, unstable angina, nearly six months prior to screening the myocardial infarction, require drug treatment of tachycardia/slow, three degree atrioventricular block, etc.;
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 |
|---|---|---|
| Recombinant Human Serum Albumin10 g/bottle (20%, 50 mL) | Drug | Control group |
| Human serum albumin10 g/bottle (20%, 50 mL) | Drug | test group |
Primary outcome
TEAE
Time frame: 57 days
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms)., TEAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
SAE
Time frame: 57 days
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms). SAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
11 secondary outcomes
AUC0-last
Time frame: 57 days
Pharmacokinetic characteristics
Time frame: 57 day
Albumin concentration of D15
Time frame: 1 day
Albumin concentration of D29
Time frame: 1 day
Albumin concentration of D57
Time frame: 1 day
t1/2
Time frame: 57 days
CL
Time frame: 57 days
Cpost-Cpre
Time frame: 14 days
Plasma colloid osmotic pressure
Time frame: 17 days
the Anti-Drug antibody (ADA) of rHSA
Time frame: 57 days
the Anti-Drug antibody (ADA) of HCP
Time frame: 57 days
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 11 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Rui Chen, Ph.D study director
Peking Union Medical College Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Human Serum Albumin and Human serum albumin in people with Hepatic Ascites, run by Beijing Protgen Biotechnology Development Co., Ltd. at 8 sites 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 4 inclusion and 15 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 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?
TEAE (time frame: 57 days). The study lists 2 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 11 Mar 2026.