Prevention of Herpes Zoster (HZ)Phase 1NCT04210752
Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
A Phase 1 study testing Treatment 1 (EG-HZ-001), Treatment 2 (EG-HZ-002) and Treatment 3 (EG-HZ-003) in people with Prevention of Herpes Zoster (HZ), run by EyeGene Inc. at 1 site in Australia.
Trial summary
This is a Phase 1, first in human (FIH), randomised, active-controlled, double-blind study designed to assess the safety and tolerability and explore preliminary efficacy of the EG-HZ vaccine. Oversight will be provided by a Safety Review Committee (SRC). Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Herpes Zoster (HZ)
- What is being tested?
- Treatment 1 (EG-HZ-001), Treatment 2 (EG-HZ-002) and Treatment 3 (EG-HZ-003)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Feb 2020to 3 Dec 2020
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure;
- Healthy male and female volunteers aged 50 to 70 years at time of Screening;
- Subjects must have a BMI between ≥18.0 and ≤35.0 kg/m2 at Screening;
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements;
- Must have a negative urine pregnancy test on the day of dosing prior to each vaccination;
- Subjects must have clinical laboratory values within normal ranges as specified by the testing laboratory, unless deemed NCS by the PI;
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- Normal physical findings, vital signs, 12-lead ECG, and no significant medical condition at the time of Screening, as judged by the PI;
- Must agree to abstain from alcohol intake from 48 hours before each vaccination;
- Must be non-smokers or, if light or occasional smokers (<10 cigarettes per day), must agree to abstain from smoking from 48 hours before each vaccination;
- Must have a negative urine drug screen/alcohol breath test on the day of dosing prior to each vaccination. Repeat urine drug screens will be permitted for suspected false positive results;
- Must agree to use highly effective, medically accepted double-barrier contraception (both male and female partners) from Screening until study completion as specified below in this criterion. Highly effective double-barrier contraception is defined as use of a condom
- AND one of the following:
- Birth control pills (The Pill)
- Depot or injectable birth control
- IUD
- Birth Control Patch (e.g., Ortho Evra)
- NuvaRing®
- Implantable contraception (e.g., Implanon)
- Documented evidence of surgical sterilisation at least 6 months prior to Screening, i.e., tubal ligation or hysterectomy for women or vasectomy for men
Who cannot join
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
- History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine;
- History of herpes zoster (Shingles);
- Previous vaccination against HZ (either a registered product or an investigational product through participation in a HZ vaccine study);
- Previous vaccination against VZV;
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose (intra-articular, intra-bursal, or topical [skin or eyes] corticosteroids are permitted at the discretion of the PI);
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- History of autoimmune disease/s which required therapeutic intervention/s, or any active autoimmune disease requiring therapeutic intervention/s including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenic purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (i.e. type 1 diabetes);
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection;
- Vaccines administered or scheduled in the period from 4 weeks prior to Dose 1 through to 28 days post-vaccination dose 2, excluding licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine (to be determined at the discretion of the PI);
- Receipt of any immunoglobulins or blood/plasma products within 60 days prior to vaccination on Day 1 and until the EOS/ET visit;
- Positive test for HCV, HBsAg, or HIV antibody at Screening;
- History or presence of any clinically unstable medical, surgical or psychiatric condition, at the discretion of the Investigator;
- Active malignancy and/or history of malignancy in the past 5 years, except for completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia;
- History of significant hypersensitivity or anaphylaxis involving any drug, food or other precipitating agent (e.g., bee sting);
- Abnormal laboratory values or investigations (including ECG) that, in the opinion of the Investigator, are deemed clinically significant and would preclude participation in the study;
- Renal insufficiency defined by eGFR <90 mL/min (CKD-EPI);
- Hepatic synthetic insufficiency as defined as a serum albumin of <35 g/L; or serum bilirubin >20 μmol/L;
- Acute disease or acute stage of chronic disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C (99.5°F), regardless of the route. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the Investigator;
- Regular use of any prescribed or non-prescribed medications, including herbal remedies, which, in the opinion of the Investigator, might adversely affect the safety of the subject or the interpretability of study results. Participants who are taking a stable dose of medication for a controlled medications include, for example, stable doses of antidepressants, cholesterol lowering agents, high blood pressure medication, reflux medication, hormone replacement therapy, NSAIDs, paracetamol, occasional Ventolin, etc.);
- History of or present alcohol abuse, or excessive intake of alcohol, as judged by the Investigator;
- Blood donation or significant blood loss within 30 days prior to the first study drug administration and until the EOS/ET visit;
- Plasma donation within 7 days prior to the first study drug administration and until the EOS/ET visit;
- Administration of another IP (defined as a compound that has not been approved for marketing) or has participated in any other clinical study that included IP treatment within 3 months prior to administration of IP in this study;
- Any person who is initially excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness) may be considered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria;
- Subject taking any non-topical antiviral therapy with activity against herpes viruses, including but not limited to acyclovir, famciclovir, ganciclovir, and valacyclovir 3 days prior to vaccination or 14 days after;
- Any other reason that, in the opinion of the Investigator, might interfere with the evaluation required by the study;
- The subject is, in the opinion of the Investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Q-Pharm Pty Ltd (Nucleus Network)
Herston, Queensland, 4006,
About this study
Official title: A Phase 1, Randomised, Activator-Controlled, Double-Blind, Parallel Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
This is a Phase 1, first in human (FIH), randomised, active-controlled, double-blind study designed to assess the safety and tolerability and explore preliminary efficacy of the EG-HZ vaccine. Oversight will be provided by a Safety Review Committee (SRC).
Read the detailed description
Subjects will undergo a Screening period beginning up to 28 days prior to randomisation, the first of two vaccinations administered 2 months apart, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).
Subjects will be randomised prior to vaccination on Day 1, to one (1) of five (5) treatment groups.
- Conditions
- Prevention of Herpes Zoster (HZ)
- Being tested
- Treatment 1 (EG-HZ-001), Treatment 2 (EG-HZ-002), Treatment 3 (EG-HZ-003), Treatment 4 (EG-HZ-004), Treatment 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment 1 (EG-HZ-001)Drug
Also called EG-HZ
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment 2 (EG-HZ-002)Drug
Also called EG-HZ
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment 3 (EG-HZ-003)Drug
Also called EG-HZ
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment 4 (EG-HZ-004)Drug
Also called EG-HZ
Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of Administration: IM injection
Treatment 5Drug
Also called Comparator
Shingrix
Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL.
Route of Administration: IM injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 (EG-HZ-001) | Experimental | Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection Receives: Drug: Treatment 1 (EG-HZ-001) |
| Treatment 2 (EG-HZ-002) | Experimental | Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection Receives: Drug: Treatment 2 (EG-HZ-002) |
| Treatment 3 (EG-HZ-003) | Experimental | Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection Receives: Drug: Treatment 3 (EG-HZ-003) |
| Treatment 4 (EG-HZ-004) | Experimental | Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
Route of administration: Intramuscular injection Receives: Drug: Treatment 4 (EG-HZ-004) |
| Treatment 5 (Shingrix) | Experimental | Shingrix
Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL.
Route of Administration: Intramuscular injection Receives: Drug: Treatment 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety and tolerability determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters. It is an composite Outcome
Measured: Through study completion, estimated 9 months
Secondary outcomes (1)
To explore the immunogenicity of EG-HZ at various excipient combinations
Immunogenicity is determined by Anti-Glycoprotein E total immunoglobulin G (IgG) antibody concentration at 1 month (Day 90) and 6 months (Day 240) post last vaccination.
Humoral immunity: anti-Varicella zoster virus total IgG antibody; anti-Glycoprotein E total IgG antibody.
Cell-mediated immunity: CD4+ T cell; CD8+ T cell
Measured: Blood samples for analysis of immunogenicity will be collected pre-dose and at multiple time points post-dose following administration of each vaccination. Through study completion, estimated 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start24 Feb 2020
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Herpes Zoster (HZ)Studies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeGene Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210752
- Sponsor's protocol ID
- EG-HZ-101
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
PubMed 37781954
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Activator-Controlled, Double-Blind, Parallel Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04210752
- Acronym / sponsor ID
- EG-HZ-101
- Conditions
- Prevention of Herpes Zoster (HZ)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- EyeGene Inc.University, hospital or other
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 26 Dec 2019 (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 is a Phase 1, first in human (FIH), randomised, active-controlled, double-blind study designed to assess the safety and tolerability and explore preliminary efficacy of the EG-HZ vaccine. Oversight will be provided by a Safety Review Committee (SRC).
Detailed description
Subjects will undergo a Screening period beginning up to 28 days prior to randomisation, the first of two vaccinations administered 2 months apart, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).
Subjects will be randomised prior to vaccination on Day 1, to one (1) of five (5) treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 (EG-HZ-001) | Experimental | Drug: Treatment 1 (EG-HZ-001)Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of administration: Intramuscular injection |
| Treatment 2 (EG-HZ-002) | Experimental | Drug: Treatment 2 (EG-HZ-002)Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of administration: Intramuscular injection |
| Treatment 3 (EG-HZ-003) | Experimental | Drug: Treatment 3 (EG-HZ-003)Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of administration: Intramuscular injection |
| Treatment 4 (EG-HZ-004) | Experimental | Drug: Treatment 4 (EG-HZ-004)Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of administration: Intramuscular injection |
| Treatment 5 (Shingrix) | Experimental | Drug: Treatment 5Shingrix Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL. Route of Administration: Intramuscular injection |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure;
- Healthy male and female volunteers aged 50 to 70 years at time of Screening;
- Subjects must have a BMI between ≥18.0 and ≤35.0 kg/m2 at Screening;
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements;
- Must have a negative urine pregnancy test on the day of dosing prior to each vaccination;
Key exclusion criteria (27 listed)
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
- History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine;
- History of herpes zoster (Shingles);
- Previous vaccination against HZ (either a registered product or an investigational product through participation in a HZ vaccine study);
- Previous vaccination against VZV;
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 |
|---|---|---|
| Treatment 1 (EG-HZ-001)Also: EG-HZSubjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection | Drug | Treatment 1 (EG-HZ-001) |
| Treatment 2 (EG-HZ-002)Also: EG-HZSubjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection | Drug | Treatment 2 (EG-HZ-002) |
| Treatment 3 (EG-HZ-003)Also: EG-HZSubjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection | Drug | Treatment 3 (EG-HZ-003) |
| Treatment 4 (EG-HZ-004)Also: EG-HZSubjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection | Drug | Treatment 4 (EG-HZ-004) |
| Treatment 5Also: ComparatorShingrix Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL. Route of Administration: IM injection | Drug | Treatment 5 (Shingrix) |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Through study completion, estimated 9 months
Safety and tolerability determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters. It is an composite Outcome
1 secondary outcome
To explore the immunogenicity of EG-HZ at various excipient combinations
Time frame: Blood samples for analysis of immunogenicity will be collected pre-dose and at multiple time points post-dose following administration of each vaccination. Through study completion, estimated 9 months
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 8 Feb 2021.
- Derived from this study: PubMed 37781954de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment 1 (EG-HZ-001), Treatment 2 (EG-HZ-002) and Treatment 3 (EG-HZ-003) in people with Prevention of Herpes Zoster (HZ), run by EyeGene Inc. at 1 site in Australia.
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 19 inclusion and 27 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 8 Feb 2021. 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 Australia. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Through study completion, estimated 9 months). 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 NCT04210752, which also lists 1 linked publication.
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 8 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.