Rabies Vaccine Adverse ReactionPhase 3NCT06078423
A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)
A Phase 3 study testing Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program and Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program in people with Rabies Vaccine Adverse Reaction, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2 Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Vaccine Adverse Reaction
- What is being tested?
- Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program and Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,880 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2019to 26 Sep 2022
- Phase
- Phase 3
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age range from 10 to 60 years old;
- Willing to participate in this experiment and sign an informed consent or notification form;
- The subjects themselves or/and their guardians promise to comply with the requirements of the clinical research protocol;
- Under the age of 14 (including 14 years old), the axillary body temperature is less than 37.5 ℃, and above the age of 14, the axillary body temperature is less than 37.3 ℃
Who cannot join
- Have a history of rabies vaccine immunization or use of rabies virus passive immunity preparations;
- Have a history of injury to dogs or other mammals within 12 months prior to the first vaccination;
- Have used blood products within 4 months before the first vaccination;
- Inoculate any vaccine within 14 days before the first vaccination;
- Have used other research or unregistered products (drugs or vaccines) within one month before the first vaccination, or have planned to participate in other clinical studies after enrollment in this clinical study;
- Suffering from congenital or acquired immune deficiency. Receiving immunosuppressive therapy, such as long-term (oral) systemic glucocorticoid therapy (continuous (oral) systemic glucocorticoid therapy for more than 2 weeks, such as prednisone or similar drugs);
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- Have a history of convulsion, epilepsy, encephalopathy, psychosis or family history;
- Allergic to any component in the study vaccine (such as human albumin, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, sucrose, maltose, etc.); Have a history of severe allergies, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthur reaction);
- Have any previous history of serious side effects from vaccines or drugs, such as urticaria, skin eczema, respiratory difficulties, vascular and neurological edema, etc;
- Individuals with acute febrile diseases (body temperature ≥ 38.5 ℃) and infectious diseases within 3 days before vaccination;
- Having congenital heart disease, developmental disorder or chronic disease, such as asthma, diabetes, thyroid disease;
- Suffering from urticaria within one year before receiving the experimental vaccine;
- Blood pressure: systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg (regardless of medication);
- Suffering from thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection);
- Women of childbearing age who have a positive urine pregnancy test, or have a fertility plan during pregnancy, lactation, or within 2 months;
- Any situation that the researcher believes may affect the evaluation of the experiment
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
Official title: Randomized, Blind, Phase III Clinical Trial Comparing the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (MRC-5 Cells) With a 5-dose Program and a 4-dose (2-dose First-dose) Program
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2
Read the detailed description
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.
Phase 1: 40 adult subjects aged 18-60 were randomly assigned to receive the trial vaccine in a 1:1 ratio according to a 5-dose immunization program (0, 3, 7, 14, 28 days) or a 4-dose immunization program (0, 7, 21 days (2 doses for the first dose). The number of recipients for each immunization program was 20. All subjects in the adult group underwent a preliminary safety assessment 7 days after the first dose of vaccination (before the third dose of vaccine), but did not meet the suspension/termination criteria. A further 40 underage subjects aged 10-17 were enrolled in the same order as the adult group, and all subjects underwent a preliminary safety assessment 7 days after the full dose of vaccination. If they did not meet the suspension/termination criteria, they entered the second phase of the study.
Phase 2: A total of 1800 subjects aged 10 to 60 years old were randomly assigned to three groups in a 1:1:1 ratio, namely the 5-dose experimental group (vaccinated with the 5-dose program), the 5-dose control group (vaccinated with the 5-dose program), and the 4-dose experimental group (vaccinated with the 4-dose program). All subjects collected blood samples before the first dose, 7 days after the first dose, 14 days after the first dose, and 14 days after the entire dose for immunogenicity evaluation; Subjects who meet the requirements for immune persistence observation in the plan shall collect blood samples 3 months after the full vaccination, and the experimental group subjects shall also collect blood samples 12 months after the full vaccination for immune persistence evaluation.
Collect all AEs from participants within 30 minutes after each dose, collected AEs within 0-7 days after each dose (if the interval from the current dose to the next dose is less than 7 days, the collection period shall be based on the actual interval between the two doses), all non collected AEs within 30 days after the first dose to the entire dose, and all serious adverse events (SAE) within 6 months after the first dose to the entire dose.
- Conditions
- Rabies Vaccine Adverse Reaction
- Being tested
- Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program
- Keywords
- Safety, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose programBiological
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose programBiological
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose programBiological
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose programBiological
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
| Study group | Role | What they receive |
|---|---|---|
| Investigational Vaccine - 5-dose program | Experimental | Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. Receives: Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program |
| Investigational Vaccine - 4-dose program | Experimental | Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. Receives: Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program |
| Control vaccine - 5-dose program | Active comparator | Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd Receives: Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program |
| Control vaccine - 4-dose program | Active comparator | Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd Receives: Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Measured: up to 14 days after the first/full dose of vaccination
Geometric mean concentration - Immunogenicity endpoint
GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Measured: 14 days after the first/full dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of any local and systemic adverse events (AEs)
Measured: within 30 minutes after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of collected AEs
Measured: within 0-7 days after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of non solicited AE
Measured: within 30 days after the first dose of vaccination to the full course of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of all serious adverse events (SAE)
Measured: within 6 months after the first dose administration and the entire vaccination process
Secondary outcomes (4)
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Measured: 7 days after the first dose of vaccination；3 month after full dose of vaccination；
Geometric mean concentration - Immunogenicity endpoint
GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Measured: 7 days after the first dose of vaccination;3 month after full dose of vaccination；
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity in the 5-dose and 4-dose test groups
Measured: 12 month after full dose of vaccination；
Geometric mean concentration - Immunogenicity endpoint
GMC of the 5-dose and 4-dose test groups
Measured: 12 month after full dose of vaccination；
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start19 Oct 2019
- Primary completion21 Jul 2021
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Vaccine Adverse ReactionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Similar vaccine control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Fangjun Li, Bachelor, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078423
- Sponsor's protocol ID
- 2018-Rab01
- Status last verified
- Oct 2023
- First submitted
- 13 Jun 2023
- Last updated
- 11 Oct 2023
- 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 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blind, Phase III Clinical Trial Comparing the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (MRC-5 Cells) With a 5-dose Program and a 4-dose (2-dose First-dose) Program
- ClinicalTrials.gov ID
- NCT06078423
- Acronym / sponsor ID
- 2018-Rab01
- Conditions
- Rabies Vaccine Adverse Reaction
- Keywords
- Safety, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,880 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 11 Oct 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 trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2
Detailed description
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.
Phase 1: 40 adult subjects aged 18-60 were randomly assigned to receive the trial vaccine in a 1:1 ratio according to a 5-dose immunization program (0, 3, 7, 14, 28 days) or a 4-dose immunization program (0, 7, 21 days (2 doses for the first dose). The number of recipients for each immunization program was 20. All subjects in the adult group underwent a preliminary safety assessment 7 days after the first dose of vaccination (before the third dose of vaccine), but did not meet the suspension/termination criteria. A further 40 underage subjects aged 10-17 were enrolled in the same order as the adult group, and all subjects underwent a preliminary safety assessment 7 days after the full dose of vaccination. If they did not meet the suspension/termination criteria, they entered the second phase of the study.
Phase 2: A total of 1800 subjects aged 10 to 60 years old were randomly assigned to three groups in a 1:1:1 ratio, namely the 5-dose experimental group (vaccinated with the 5-dose program), the 5-dose control group (vaccinated with the 5-dose program), and the 4-dose experimental group (vaccinated with the 4-dose program). All subjects collected blood samples before the first dose, 7 days after the first dose, 14 days after the first dose, and 14 days after the entire dose for immunogenicity evaluation; Subjects who meet the requirements for immune persistence observation in the plan shall collect blood samples 3 months after the full vaccination, and the experimental group subjects shall also collect blood samples 12 months after the full vaccination for immune persistence evaluation.
Collect all AEs from participants within 30 minutes after each dose, collected AEs within 0-7 days after each dose (if the interval from the current dose to the next dose is less than 7 days, the collection period shall be based on the actual interval between the two doses), all non collected AEs within 30 days after the first dose to the entire dose, and all serious adverse events (SAE) within 6 months after the first dose to the entire dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Similar vaccine control
| Arm | Type | Receives |
|---|---|---|
| Investigational Vaccine - 5-dose program | Experimental | Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose programFreeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. |
| Investigational Vaccine - 4-dose program | Experimental | Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose programFreeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. |
| Control vaccine - 5-dose program | Active comparator | Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose programFreeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd |
| Control vaccine - 4-dose program | Active comparator | Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose programFreeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age range from 10 to 60 years old;
- Willing to participate in this experiment and sign an informed consent or notification form;
- The subjects themselves or/and their guardians promise to comply with the requirements of the clinical research protocol;
- Under the age of 14 (including 14 years old), the axillary body temperature is less than 37.5 ℃, and above the age of 14, the axillary body temperature is less than 37.3 ℃
Key exclusion criteria (16 listed)
- Have a history of rabies vaccine immunization or use of rabies virus passive immunity preparations;
- Have a history of injury to dogs or other mammals within 12 months prior to the first vaccination;
- Have used blood products within 4 months before the first vaccination;
- Inoculate any vaccine within 14 days before the first vaccination;
- Have used other research or unregistered products (drugs or vaccines) within one month before the first vaccination, or have planned to participate in other clinical studies after enrollment in this clinical study;
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 |
|---|---|---|
| Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose programInoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm | Biological | Investigational Vaccine - 5-dose program |
| Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose programInoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm | Biological | Investigational Vaccine - 4-dose program |
| Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose programInoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm | Biological | Control vaccine - 5-dose program |
| Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose programInoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm | Biological | Control vaccine - 4-dose program |
Primary outcome
Antibody positive conversion rate - Immunogenicity endpoint
Time frame: up to 14 days after the first/full dose of vaccination
Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Geometric mean concentration - Immunogenicity endpoint
Time frame: 14 days after the first/full dose of vaccination
GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Incidence of Adverse Events [Safety and Tolerability]
Time frame: within 30 minutes after each dose of vaccination
The incidence of any local and systemic adverse events (AEs)
Incidence of Adverse Events [Safety and Tolerability]
Time frame: within 0-7 days after each dose of vaccination
The incidence of collected AEs
Incidence of Adverse Events [Safety and Tolerability]
Time frame: within 30 days after the first dose of vaccination to the full course of vaccination
The incidence of non solicited AE
Incidence of Adverse Events [Safety and Tolerability]
Time frame: within 6 months after the first dose administration and the entire vaccination process
The incidence of all serious adverse events (SAE)
4 secondary outcomes
Antibody positive conversion rate - Immunogenicity endpoint
Time frame: 7 days after the first dose of vaccination；3 month after full dose of vaccination；
Geometric mean concentration - Immunogenicity endpoint
Time frame: 7 days after the first dose of vaccination;3 month after full dose of vaccination；
Antibody positive conversion rate - Immunogenicity endpoint
Time frame: 12 month after full dose of vaccination；
Geometric mean concentration - Immunogenicity endpoint
Time frame: 12 month after full dose of vaccination；
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 Oct 2023.
- Individual participant dataSharing planned: No
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.
Fangjun Li, Bachelor principal investigator
Hunan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program and Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program in people with Rabies Vaccine Adverse Reaction, run by Anhui Zhifei Longcom Biologic Pharmacy 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 4 inclusion and 16 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 Oct 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Antibody positive conversion rate - Immunogenicity endpoint (time frame: up to 14 days after the first/full dose of vaccination). The study lists 6 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 Oct 2023.