Staphylococcus Aureus BacteremiaPhase 2NCT03089697
Phase IIa Clinical Study of N-Rephasin® SAL200
A Phase 2 study testing N-Rephasin® SAL200 in people with Staphylococcus Aureus Bacteremia and Anti-Bacterial Agents, run by Intron Biotechnology, Inc. at 2 sites in South Korea.
Trial summary
This study is performed to evaluate safety and to explore the efficacy of a single intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard treatment, for persistent Staphylococcus aureus bacteremia in patients, for more than 48 hours even after antibiotic treatment to which… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia, Anti-Bacterial Agents
- What is being tested?
- N-Rephasin® SAL200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 7 Mar 2017to 7 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with MSSA/MRSA bacteremia who are confirmed to have more than a pair of Gram positive bacteria in a blood culture conducted at 48~96 hours after the start of antibiotic treatment to which S. aureus is susceptible.
- Males or females aged 19 years or older
- Those who understand the explanatory notes for subjects, and sign the informed consent.
Who cannot join
- Those who do not receive appropriate antibiotics within 48 hours after the occurrence of bacteremia (the time point of reporting it to the department of laboratory medicine)
- The Gram positive strain, identified in a blood culture conducted at 48~96 hours after the start of antibiotic treatment to which S. aureus is susceptible, is not the same strain of S. aureus which was cultured when the definite diagnosis of S. aureus bacteremia was made
- Those who pass 48 hours after confirmation of persistent S. aureus bacteremia through a blood culture conducted at 48~96 hours after the start of antibiotic treatment to which S. aureus is susceptible
- Those who have symptoms of septic shock at the time of acquisition of the consent form
- Systolic blood pressure lower than 90 mmHg, or blood pressure lower than usual by more than 40 mmHg, in spite of the application of appropriate fluid therapy
- Requirement of hypertensor to maintain the systolic blood pressure at 90 mmHg or higher
Show all 12Show fewer
- Those who were infected with mixed bacterial species
- Those who are hypersensitive to N-Rephasin® SAL200, who have a clinically significant hypersensitivity to it, or a past history there of
- Pregnant or lactating women and women of child-bearing potential (who do not agree to take appropriate contraceptive measures during the trial period)
- Those who participated in other clinical trial within 30 days prior to enrollment
- Patients with any conditions that may interfere with study participation or accurate evaluation on investigator's judgment
- Those who may die within 72 hours due to other serious complications (e.g., cerebral infarction, etc.), as per the investigator's judgment
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase IIa Clinical Study to Evaluate Safety and to Explore Efficacy of N-Rephasin® SAL200, in Patients With Persistent Staphylococcus Aureus Bacteremia
This study is performed to evaluate safety and to explore the efficacy of a single intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard treatment, for persistent Staphylococcus aureus bacteremia in patients, for more than 48 hours even after antibiotic treatment to which Staphylococcus aureus is susceptible.
Read the detailed description
Subjects:
Patients with persistent Staphylococcus aureus bacteremia for more than 48 hours from the beginning of antibiotics treatment to which Staphylococcus aureus is susceptible.
Study Method:
- Selection of patients with persistent S.aureus bacteremia for more than 48 hours even after application of the standard treatment for S. aureus bacteremia
- Randomization according to the trial institutions
- The control group receives a single intravenous dose of the placebo in addition to the standard treatment for persistent Staphylococcus aureus bacteremia
- The study group receives a single intravenous dose of the N-Rephasin® SAL200 (3 mg/kg) in addition to the standard treatment for persistent Staphylococcus aureus bacteremia
- A blood culture is performed 18 hours (±6 hours) after the administration of N-Rephasin® SAL200
- Blood cultures continue to be performed every 24 hours (±6 hours) or 48 hours (±6 hours) after the previous blood culture, until two consecutive results of 'no growth (negative conversion)' are obtained
- Adverse events are monitored at the time of the first blood culture following the administration of N-Rephasin® SAL200 or placebo, and at the subsequent intervals of 24 hours or 48 hours
Statistical Analysis:
- Primary endpoints
- Safety analysis is conducted in the Safety group. A distribution table of patients who experience at least one adverse event (incidence), and distribution tables of the relationship of the reported adverse events with the investigational product (distribution tables for severity and the relationship with the drug) are presented with respect to the groups (study group, control group), to determine safety of the investigational product.
- The results of the laboratory tests, anaphylaxis test, inflammatory cytokine test and vital signs at baseline and the last visit are summarized as mean values and standard deviations, to determine the change before and after the treatment within each group.
- Categorical data are divided into normal and abnormal, and summarized as the frequency and percentage to determine the difference before and after treatment within each group.
- Secondary endpoints
- Proportion of patients who are negative for bacterial growth in the first blood culture after administration of the investigational drug. The descriptive statistics for the proportion of patients who are negative for bacterial growth in the first blood culture (the rate of no growth) after the first treatment are presented by treatment group. Whether the rate of no growth is superior in the study group compared to the control group, is evaluated by a descriptive statistical method.
- Proportion of patients who die due to S. aureus bacteremia by Day14 after the incidence of bacteremia. The descriptive statistics for the proportion of patients who die due to S. aureus bacteremia by Day14 are presented by treatment group and evaluated.
- Proportion of treatment failure for S. aureus bacteremia by Day 14 (if two consecutive results of 'no growth' are not achieved in the blood cultures which are performed until Day 14. The descriptive statistics for the proportion of treatment failure for S. aureus bacteremia by Day 14 are presented and evaluated.
- Being tested
- N-Rephasin® SAL200, Placebo
- Keywords
- N-Rephasin SAL200, Methicillin-Sensitive Staphylococcus aureus, Methicillin Resistant Staphylococcus Aureus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Rephasin® SAL200Biological
A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
PlaceboOther
A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
| Study group | Role | What they receive |
|---|---|---|
| N-Rephasin® SAL200 | Experimental | To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1. Receives: Biological: N-Rephasin® SAL200 |
| Placebo | Placebo comparator | To assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set)
The safety analysis was conducted based on the data of all AEs, physical examinations, clinical laboratory tests, and vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) collected from the subjects.
All subjects who enrolled in this study (13 subjects in the placebo group and 12 subjects in the N RephasinⓇ SAL200 group) were defined as the Safety Set and included in the analysis.
Measured: up to 4 Week ± 5 Days
Secondary outcomes (3)
Efficacy Endpoints 1
Number of Participants With Negative Result in the First Blood Culture
Measured: by day 14
Efficacy Endpoint 2
The Proportion (Percentage) of Subjects who Died of Staphylococcus aureus Bacteremia Within 14 Days of Bacteremia Diagnosis
Measured: by day 14
Efficacy Endpoint 3
Proportion (Percentage) of Treatment Failure Against Staphylococcus aureus Bacteremia by Day 14
Measured: by day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start7 Mar 2017
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
Why it stopped: Enrollment into this study was terminated by the Sponsor prior to completion for strategic reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Aureus BacteremiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intron Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong-Bin Kim, M.D, PhD, Principal investigator, Seoul National University Bundang HospitalWan Beom Park, M.D, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089697
- Sponsor's protocol ID
- ITB-101
- Status last verified
- Sep 2021
- First submitted
- 23 Feb 2017
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kundsin RB. Documentation of airborne infection during surgery. Ann N Y Acad Sci. 1980;353:255-61. doi: 10.1111/j.1749-6632.1980.tb18928.x. No abstract available.
PubMed 6939390Etienne J, Fleurette J, Ninet JF, Favet P, Gruer LD. Staphylococcal endocarditis after dental extraction. Lancet. 1986 Aug 30;2(8505):511-2. doi: 10.1016/s0140-6736(86)90377-6. No abstract available.
PubMed 2875256Lamy B, Dargere S, Arendrup MC, Parienti JJ, Tattevin P. How to Optimize the Use of Blood Cultures for the Diagnosis of Bloodstream Infections? A State-of-the Art. Front Microbiol. 2016 May 12;7:697. doi: 10.3389/fmicb.2016.00697. eCollection 2016.
PubMed 27242721van Hal SJ, Jensen SO, Vaska VL, Espedido BA, Paterson DL, Gosbell IB. Predictors of mortality in Staphylococcus aureus Bacteremia. Clin Microbiol Rev. 2012 Apr;25(2):362-86. doi: 10.1128/CMR.05022-11.
PubMed 22491776
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase IIa Clinical Study to Evaluate Safety and to Explore Efficacy of N-Rephasin® SAL200, in Patients With Persistent Staphylococcus Aureus Bacteremia
- ClinicalTrials.gov ID
- NCT03089697
- Acronym / sponsor ID
- ITB-101
- Keywords
- N-Rephasin SAL200, Methicillin-Sensitive Staphylococcus aureus, Methicillin Resistant Staphylococcus Aureus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment into this study was terminated by the Sponsor prior to completion for strategic reasons.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Intron Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 17 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is performed to evaluate safety and to explore the efficacy of a single intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard treatment, for persistent Staphylococcus aureus bacteremia in patients, for more than 48 hours even after antibiotic treatment to which Staphylococcus aureus is susceptible.
Detailed description
Subjects:
Patients with persistent Staphylococcus aureus bacteremia for more than 48 hours from the beginning of antibiotics treatment to which Staphylococcus aureus is susceptible.
Study Method:
- Selection of patients with persistent S.aureus bacteremia for more than 48 hours even after application of the standard treatment for S. aureus bacteremia
- Randomization according to the trial institutions
- The control group receives a single intravenous dose of the placebo in addition to the standard treatment for persistent Staphylococcus aureus bacteremia
- The study group receives a single intravenous dose of the N-Rephasin® SAL200 (3 mg/kg) in addition to the standard treatment for persistent Staphylococcus aureus bacteremia
- A blood culture is performed 18 hours (±6 hours) after the administration of N-Rephasin® SAL200
- Blood cultures continue to be performed every 24 hours (±6 hours) or 48 hours (±6 hours) after the previous blood culture, until two consecutive results of 'no growth (negative conversion)' are obtained
- Adverse events are monitored at the time of the first blood culture following the administration of N-Rephasin® SAL200 or placebo, and at the subsequent intervals of 24 hours or 48 hours
Statistical Analysis:
- Primary endpoints
- Safety analysis is conducted in the Safety group. A distribution table of patients who experience at least one adverse event (incidence), and distribution tables of the relationship of the reported adverse events with the investigational product (distribution tables for severity and the relationship with the drug) are presented with respect to the groups (study group, control group), to determine safety of the investigational product.
- The results of the laboratory tests, anaphylaxis test, inflammatory cytokine test and vital signs at baseline and the last visit are summarized as mean values and standard deviations, to determine the change before and after the treatment within each group.
- Categorical data are divided into normal and abnormal, and summarized as the frequency and percentage to determine the difference before and after treatment within each group.
- Secondary endpoints
- Proportion of patients who are negative for bacterial growth in the first blood culture after administration of the investigational drug. The descriptive statistics for the proportion of patients who are negative for bacterial growth in the first blood culture (the rate of no growth) after the first treatment are presented by treatment group. Whether the rate of no growth is superior in the study group compared to the control group, is evaluated by a descriptive statistical method.
- Proportion of patients who die due to S. aureus bacteremia by Day14 after the incidence of bacteremia. The descriptive statistics for the proportion of patients who die due to S. aureus bacteremia by Day14 are presented by treatment group and evaluated.
- Proportion of treatment failure for S. aureus bacteremia by Day 14 (if two consecutive results of 'no growth' are not achieved in the blood cultures which are performed until Day 14. The descriptive statistics for the proportion of treatment failure for S. aureus bacteremia by Day 14 are presented and evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Rephasin® SAL200 | Experimental | Biological: N-Rephasin® SAL200To assign the study group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with N-Rephasin® SAL200 (3mg/kg); N-Rephasin® SAL 200 is given by intravenous only once at Day 1. |
| Placebo | Placebo comparator | Other: PlaceboTo assign the control group, administer the conventional standard treatment (CST) (antibiotics) for MRSA/MSSA with Formulation buffer (placebo); Placebo (INT200) is given by intravenous only once at Day 1 (same way with Experimental group) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with MSSA/MRSA bacteremia who are confirmed to have more than a pair of Gram positive bacteria in a blood culture conducted at 48~96 hours after the start of antibiotic treatment to which S. aureus is susceptible.
- Males or females aged 19 years or older
- Those who understand the explanatory notes for subjects, and sign the informed consent.
Key exclusion criteria (12 listed)
- Those who do not receive appropriate antibiotics within 48 hours after the occurrence of bacteremia (the time point of reporting it to the department of laboratory medicine)
- The Gram positive strain, identified in a blood culture conducted at 48~96 hours after the start of antibiotic treatment to which S. aureus is susceptible, is not the same strain of S. aureus which was cultured when the definite diagnosis of S. aureus bacteremia was made
- Those who pass 48 hours after confirmation of persistent S. aureus bacteremia through a blood culture conducted at 48~96 hours after the start of antibiotic treatment to which S. aureus is susceptible
- Those who have symptoms of septic shock at the time of acquisition of the consent form
- Those who were infected with mixed bacterial species
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 |
|---|---|---|
| N-Rephasin® SAL200A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA | Biological | N-Rephasin® SAL200 |
| PlaceboA single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA | Other | Placebo |
Primary outcome
Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set)
Time frame: up to 4 Week ± 5 Days
The safety analysis was conducted based on the data of all AEs, physical examinations, clinical laboratory tests, and vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) collected from the subjects. All subjects who enrolled in this study (13 subjects in the placebo group and 12 subjects in the N RephasinⓇ SAL200 group) were defined as the Safety Set and included in the analysis.
3 secondary outcomes
Efficacy Endpoints 1
Time frame: by day 14
Efficacy Endpoint 2
Time frame: by day 14
Efficacy Endpoint 3
Time frame: by day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 6939390Kundsin RB. Documentation of airborne infection during surgery. Ann N Y Acad Sci. 1980;353:255-61. doi: 10.1111/j.1749-6632.1980.tb18928.x. No abstract available.
- Results publication: PubMed 2875256Etienne J, Fleurette J, Ninet JF, Favet P, Gruer LD. Staphylococcal endocarditis after dental extraction. Lancet. 1986 Aug 30;2(8505):511-2. doi: 10.1016/s0140-6736(86)90377-6. No abstract available.
- Results publication: PubMed 27242721Lamy B, Dargere S, Arendrup MC, Parienti JJ, Tattevin P. How to Optimize the Use of Blood Cultures for the Diagnosis of Bloodstream Infections? A State-of-the Art. Front Microbiol. 2016 May 12;7:697. doi: 10.3389/fmicb.2016.00697. eCollection 2016.
- Results publication: PubMed 22491776van Hal SJ, Jensen SO, Vaska VL, Espedido BA, Paterson DL, Gosbell IB. Predictors of mortality in Staphylococcus aureus Bacteremia. Clin Microbiol Rev. 2012 Apr;25(2):362-86. doi: 10.1128/CMR.05022-11.
- Frency J, Brun Y, Bes M, Meugnier H, Grimont F, Grimon PAD, Newi C, Fleurette J. Staphylococcus lugdunensis sp. and Staphylococcus schleiferi sp. novel two species from human clinical specimens. Int Syst Bacteriol. 1998;38:168-172Link provided by the sponsor.
- Seung-Ho Han et al., Monitoring of Methicillin-Resistant Staphylococcus aureus in Nasal Swabs Obtained fron Dental Clinic Healthcare Providers and Medical Environments Nurses. Int J Oral Biology. 2010;35:7-12Link provided by the sponsor.
- Hyuk Min Lee, Dong Eun Yong, Kyungwon Lee., Antimicrobial Resistance of Clinically Important Bacteria Isolated from 12 Hospitals in Korea in 2004 . Korean Journal of Clinical Microbiology 2005;8(1):66-73Link provided by the sponsor.
- Siegel JD, Rhinehart E, Jackson M, Chiarello L. Management of multidrug-resistant organisms in health care settings, 2006. Am J Infect Control 2007;35(10 SUPPL. 2):S165-93.Link provided by the sponsor.
- Woo J-H, Song J-H, Cheong H-S, Lee E-K, Chae S-M, Kim N-J. Analysis of Economic Outcomes of Methicillin-Resistant Staphylococcus Aureus(MRSA) Bacteremia Using Retrospective Case-Control Study. Korean J Clin Pharm 2007;17(2):59-64.Link provided by the sponsor.
- Lee, H, Yong, D, Lee, K, Hong, S, Kim, E, Jung, S, Park, Y, Choi, T, Eo, Y, Shin, J et al. Antimicrobial Resistance of Clinically Important Bacteria Isolated from 12 Hospitals in Korea in 2004. Korean J Clinical Microbiology 2005;8(1):66-73Link provided by the sponsor.
- 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.
Hong-Bin Kim, M.D, PhD principal investigator
Seoul National University Bundang Hospital
Wan Beom Park, M.D, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Rephasin® SAL200 in people with Staphylococcus Aureus Bacteremia and Anti-Bacterial Agents, run by Intron Biotechnology, Inc. at 2 sites in South Korea.
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Endpoints - Summary of Treatment-emergent Adverse Events (Safety Set) (time frame: up to 4 Week ± 5 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089697, which also lists 4 linked publications.
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 6 Oct 2021.