Neisseria GonorrhoeaePhase 2NCT03222401
Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With N. Gonorrhoeae in Healthy Males
A Phase 2 study testing 1 mg/kg single infusion of F598, 3 mg/kg single infusion of F598 and 10 mg/kg single infusion of F598 in people with Neisseria Gonorrhoeae, run by Alopexx Pharmaceuticals, LLC at 1 site in United States.
Trial summary
Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled at a single center for a duration of two months for each subject. Subjects who meet the enrollment criteria will be randomized to one of four open-label groups: Control (no treatment) or treatment with F598 at one of three… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neisseria Gonorrhoeae
- What is being tested?
- 1 mg/kg single infusion of F598, 3 mg/kg single infusion of F598 and 10 mg/kg single infusion of F598
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 2 Mar 2018
- Phase
- Phase 2
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between the ages of 18 and 35 years
- Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number)
- Able and willing to provide written informed consent
- Able and willing to attend all study visits and follow-up visit during the week after treatment
- Willing to abstain from masturbation during the 6 days after inoculation
- Willing to abstain from all sexual activity during the course of the study
Show all 18Show fewer
- No clinically significant abnormalities on physical examination
- No clinically significant abnormalities in serum chemistries, hematology and urinalysis
- Urine negative for chlamydia, gonorrhea and trichomonas
- No history of sexually transmitted infections (STIs), including syphilis and hepatitis B (HBV) \& hepatitis C (HCV)
- Negative human immunodeficiency virus (HIV), syphilis and HCV serologies
- Negative HBV core and surface antibodies or results consistent with immunization (negative HBV core antibody/positive HBV surface antibody)
- No history of bleeding diathesis
- No history of seizures (due to reports of seizures with ciprofloxacin)
- No history of cancer, except basal cell carcinoma of the skin more than 5 years ago
- No history of drug abuse
- No history of psychiatric disorders, except depression controlled by medication
- No history of genitourinary surgery
Who cannot join
- Student or employee under the direct supervision of any of the study investigators
- Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection
- Sickle cell disease
- Psychiatric disorders that would interfere with the ability of the subject to comply with the requirements of the protocol
- Unstable depression (defined as receiving either <3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or depression that, in the opinion of the investigator, will compromise the subject's ability to comply with protocol requirements
- Heart murmur or heart disease
Show all 34Show fewer
- Anatomic abnormality of the urinary tract
- Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days
- Chemotherapy within the past year
- Current steroid use, except for topical application
- Allergy to penicillin, cephalosporins, ciprofloxacin or to lidocaine
- Treatment with medications that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study.
- Medications not permitted with cefixime or ceftriaxone include:
- Warfarin
- Probenecid
- Aspirin
- Diuretics such as furosemide
- Aminoglycoside antibiotics
- Chloramphenicol
- Medications not permitted with ciprofloxacin include:
- Tizanidine
- Theophylline
- Warfarin
- Glyburide
- Cyclosporine
- Probenecid
- Phenytoin
- Methotrexate
- Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc
- Caffeine-containing medications
- Sucralfate or didanosine chewable or buffered
- Major organ dysfunction
- Any significant pre-existing condition preventing full compliance with the study
- Infection or any serious underlying medical condition that would impair the ability of the subject to receive protocol treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: IGHID 11705 A Randomized, Open-label, Controlled Clinical Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With Neisseria Gonorrhoeae in Healthy Male Subjects
Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled at a single center for a duration of two months for each subject. Subjects who meet the enrollment criteria will be randomized to one of four open-label groups: Control (no treatment) or treatment with F598 at one of three doses. Following F598 administration or assignment to the Control group, subjects must return to the study site for inoculation with N. gonorrhoeae within 2 weeks. Once subjects have been inoculated with N. gonorrhoeae, they will enter the observation phase and will return to the study site daily for up to 5 days. At the end of the observation phase, definitive antibiotic therapy will be administered. A follow-up visit will be conducted 3-5 days after definitive antibiotic and a confirmatory interaction will occur with the subjects 7-10 days after the follow-up to confirm the subject's response. A final visit will occur approximately 8 weeks after inoculation.
Read the detailed description
The study is comprised of 8 phases:
- Screening (Visits 1 and 2)
- F598 administration (Visit 3)
- Inoculation (Visit 4)
- Observation (Visits 5 - 8, as needed)
- Definitive antibiotic treatment (Visit 9)
- Test of cure (Visit 10)
- Confirmatory interaction (Visit 11)
- Final pharmacokinetic (PK)/pharmacodynamic (PD)/anti-drug antibody determination (Visit 12)
For the purposes of standardization, Day 1 of the study will be considered the day of inoculation.
During the Screening phase, prospective subjects will undergo informed consent and will be reviewed for their compatibility with the eligibility criteria. Those subjects who meet all of the Inclusion criteria and none of the Exclusion criteria will be enrolled. Following enrollment, subjects must undergo a repeat urine screen for C. trachomatis, N. gonorrhoeae and T. vaginalis (Days -17 to -4).
If the second urine screening test is negative, subjects will enter the F598 administration phase. Subjects will return to the study site and will be randomized to one of four open-label groups: Control (no treatment) or treatment with F598 at one of three doses. Following F598 administration or assignment to the Control group, subjects must return to the study site for inoculation with N. gonorrhoeae within 2 weeks. Thus, F598 will be administered on any one of Days -12 to -2.
During the inoculation phase, subjects will return to the study site and receive an inoculum of N. gonorrhoeae in the anterior urethra. A third and final urine screen for C. trachomatis, N. gonorrhoeae and T. vaginalis will be obtained immediately before inoculation.
Once subjects have been inoculated with N. gonorrhoeae, they will enter the observation phase and will return to the study site daily for up to 5 days for a physical examination (in particular, for evidence of urethral discharge) and a urine sample for evidence of infection (NAAT and culture) as well as blood for F598 PK/PD and safety labs.
The observation phase will end and definitive antibiotic therapy will be administered when any one of four criteria is met:
- The subject requests antibiotic treatment
- The subject is found to by symptomatic (discharge, urethral discomfort)
- The subject has reached Day 6 of the study
Thus, depending on the circumstances, definitive antibiotic therapy can be administered between Days 2 - 6, inclusive.
A follow-up visit at the study site will be conducted 3 - 5 days after definitive antibiotic therapy has been administered to ensure treatment response. Thus, depending on when the subject received antibiotics, this visit could occur between Days 5 - 11, inclusive. A physical examination will be performed and urine for evidence of infection (NAAT) as well as blood for F598 PK/PD will be obtained.
A confirmatory interaction with the subject will occur at the study site 7 - 10 days after the follow-up visit to confirm the subject's response and answer any questions the subject may have. Thus, depending on when the subject had his follow-up visit, the confirmatory visit could occur between Days 12 - 21, inclusive. Blood for F598 PK/PD, anti-F598 antibodies and safety labs will be obtained.
A final visit will occur approximately 8 weeks after inoculation (days 52 - 60) to obtain serum for PK/PD and anti-F598 antibodies.
- Conditions
- Neisseria Gonorrhoeae
- Being tested
- 1 mg/kg single infusion of F598, 3 mg/kg single infusion of F598, 10 mg/kg single infusion of F598
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg/kg single infusion of F598Drug
Also called F598
1 mg/kg single infusion of F598
3 mg/kg single infusion of F598Drug
Also called F598
3 mg/kg single infusion of F598
10 mg/kg single infusion of F598Drug
Also called F598
10 mg/kg single infusion of F598
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control subjects will not receive an infusion or placebo |
| 1 mg/kg single infusion of F598 | Experimental | 1 mg/kg single infusion of F598 Receives: Drug: 1 mg/kg single infusion of F598 |
| 3 mg/kg single infusion of F598 | Experimental | 3 mg/kg single infusion of F598 Receives: Drug: 3 mg/kg single infusion of F598 |
| 10 mg/kg single infusion of F598 | Experimental | 10 mg/kg single infusion of F598 Receives: Drug: 10 mg/kg single infusion of F598 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of F598 in preventing an experimental urethral infection with N. gonorrhoeae
Following the inoculation of N. gonorrhoeae, assess efficacy based of the proportion of infected subjects in each treatment group
Measured: Through study completion, an average of two months
Secondary outcomes (10)
Assess the impact of F598 on urethritis symptoms caused by N. gonorrhoeae infection
Urethritis signs as measured on targeted physical examination or symptoms reported by subject
Measured: Up to 6 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Immunogenicity]
Monitor the treatment-emergent adverse events, infusion-associated reactions and anti-drug antibodies following administration of F598
Measured: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Cmax: Observed maximum serum concentration
Measured: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Tmax: Time to attain maximum serum concentration
Measured: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
T 1/2: Elimination half-life
Measured: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
AUC: Area under the serum concentration-time curve
Measured: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
CL: Total body clearance of F598 from plasma
Measured: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
V: Volume of F598 distribution at steady state
Measured: Through study completion, an average of two months
Pharmacodynamics: Associations between the PD parameters and infection rate
Blood samples for serum bactericidal activity following administration of F598
Measured: Through study completion, an average of two months
Pharmacodynamics: Associations between the PD parameters and infection rate
Blood samples for complement fixation following administration of F598
Measured: Through study completion, an average of two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start29 Nov 2017
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Why it stopped: Interim analysis suggested that the trial, as designed, was not adequately powered to detect a therapeutic effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria GonorrhoeaeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Subjects will be enrolled in 6 identical cohorts of 4 subjects each. Within each cohort, subjects will be randomized to: 1. Control (n=1) 2. F598, 1 mg/kg (n=1) 3. F598, 3 mg/kg (n=1) 4. F598, 10 mg/kg (n=1)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alopexx Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hal Landy, MD, Study director, Alopexx Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222401
- Sponsor's protocol ID
- AP-GC-201-16
- Status last verified
- Feb 2019
- First submitted
- 7 Jul 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 11705 A Randomized, Open-label, Controlled Clinical Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With Neisseria Gonorrhoeae in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03222401
- Acronym / sponsor ID
- AP-GC-201-16
- Conditions
- Neisseria Gonorrhoeae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis suggested that the trial, as designed, was not adequately powered to detect a therapeutic effect.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alopexx Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 19 Jul 2017 (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.
Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled at a single center for a duration of two months for each subject. Subjects who meet the enrollment criteria will be randomized to one of four open-label groups: Control (no treatment) or treatment with F598 at one of three doses. Following F598 administration or assignment to the Control group, subjects must return to the study site for inoculation with N. gonorrhoeae within 2 weeks. Once subjects have been inoculated with N. gonorrhoeae, they will enter the observation phase and will return to the study site daily for up to 5 days. At the end of the observation phase, definitive antibiotic therapy will be administered. A follow-up visit will be conducted 3-5 days after definitive antibiotic and a confirmatory interaction will occur with the subjects 7-10 days after the follow-up to confirm the subject's response. A final visit will occur approximately 8 weeks after inoculation.
Detailed description
The study is comprised of 8 phases:
- Screening (Visits 1 and 2)
- F598 administration (Visit 3)
- Inoculation (Visit 4)
- Observation (Visits 5 - 8, as needed)
- Definitive antibiotic treatment (Visit 9)
- Test of cure (Visit 10)
- Confirmatory interaction (Visit 11)
- Final pharmacokinetic (PK)/pharmacodynamic (PD)/anti-drug antibody determination (Visit 12)
For the purposes of standardization, Day 1 of the study will be considered the day of inoculation.
During the Screening phase, prospective subjects will undergo informed consent and will be reviewed for their compatibility with the eligibility criteria. Those subjects who meet all of the Inclusion criteria and none of the Exclusion criteria will be enrolled. Following enrollment, subjects must undergo a repeat urine screen for C. trachomatis, N. gonorrhoeae and T. vaginalis (Days -17 to -4).
If the second urine screening test is negative, subjects will enter the F598 administration phase. Subjects will return to the study site and will be randomized to one of four open-label groups: Control (no treatment) or treatment with F598 at one of three doses. Following F598 administration or assignment to the Control group, subjects must return to the study site for inoculation with N. gonorrhoeae within 2 weeks. Thus, F598 will be administered on any one of Days -12 to -2.
During the inoculation phase, subjects will return to the study site and receive an inoculum of N. gonorrhoeae in the anterior urethra. A third and final urine screen for C. trachomatis, N. gonorrhoeae and T. vaginalis will be obtained immediately before inoculation.
Once subjects have been inoculated with N. gonorrhoeae, they will enter the observation phase and will return to the study site daily for up to 5 days for a physical examination (in particular, for evidence of urethral discharge) and a urine sample for evidence of infection (NAAT and culture) as well as blood for F598 PK/PD and safety labs.
The observation phase will end and definitive antibiotic therapy will be administered when any one of four criteria is met:
- The subject requests antibiotic treatment
- The subject is found to by symptomatic (discharge, urethral discomfort)
- The subject has reached Day 6 of the study
Thus, depending on the circumstances, definitive antibiotic therapy can be administered between Days 2 - 6, inclusive.
A follow-up visit at the study site will be conducted 3 - 5 days after definitive antibiotic therapy has been administered to ensure treatment response. Thus, depending on when the subject received antibiotics, this visit could occur between Days 5 - 11, inclusive. A physical examination will be performed and urine for evidence of infection (NAAT) as well as blood for F598 PK/PD will be obtained.
A confirmatory interaction with the subject will occur at the study site 7 - 10 days after the follow-up visit to confirm the subject's response and answer any questions the subject may have. Thus, depending on when the subject had his follow-up visit, the confirmatory visit could occur between Days 12 - 21, inclusive. Blood for F598 PK/PD, anti-F598 antibodies and safety labs will be obtained.
A final visit will occur approximately 8 weeks after inoculation (days 52 - 60) to obtain serum for PK/PD and anti-F598 antibodies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Subjects will be enrolled in 6 identical cohorts of 4 subjects each. Within each cohort, subjects will be randomized to: 1. Control (n=1) 2. F598, 1 mg/kg (n=1) 3. F598, 3 mg/kg (n=1) 4. F598, 10 mg/kg (n=1)
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control subjects will not receive an infusion or placebo |
| 1 mg/kg single infusion of F598 | Experimental | Drug: 1 mg/kg single infusion of F5981 mg/kg single infusion of F598 |
| 3 mg/kg single infusion of F598 | Experimental | Drug: 3 mg/kg single infusion of F5983 mg/kg single infusion of F598 |
| 10 mg/kg single infusion of F598 | Experimental | Drug: 10 mg/kg single infusion of F59810 mg/kg single infusion of F598 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy male between the ages of 18 and 35 years
- Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number)
- Able and willing to provide written informed consent
- Able and willing to attend all study visits and follow-up visit during the week after treatment
- Willing to abstain from masturbation during the 6 days after inoculation
Key exclusion criteria (34 listed)
- Student or employee under the direct supervision of any of the study investigators
- Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection
- Sickle cell disease
- Psychiatric disorders that would interfere with the ability of the subject to comply with the requirements of the protocol
- Unstable depression (defined as receiving either <3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or depression that, in the opinion of the investigator, will compromise the subject's ability to comply with protocol requirements
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 |
|---|---|---|
| 1 mg/kg single infusion of F598Also: F5981 mg/kg single infusion of F598 | Drug | 1 mg/kg single infusion of F598 |
| 3 mg/kg single infusion of F598Also: F5983 mg/kg single infusion of F598 | Drug | 3 mg/kg single infusion of F598 |
| 10 mg/kg single infusion of F598Also: F59810 mg/kg single infusion of F598 | Drug | 10 mg/kg single infusion of F598 |
Primary outcome
Assess the efficacy of F598 in preventing an experimental urethral infection with N. gonorrhoeae
Time frame: Through study completion, an average of two months
Following the inoculation of N. gonorrhoeae, assess efficacy based of the proportion of infected subjects in each treatment group
10 secondary outcomes
Assess the impact of F598 on urethritis symptoms caused by N. gonorrhoeae infection
Time frame: Up to 6 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Immunogenicity]
Time frame: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Time frame: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Time frame: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Time frame: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Time frame: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Time frame: Through study completion, an average of two months
Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood
Time frame: Through study completion, an average of two months
Pharmacodynamics: Associations between the PD parameters and infection rate
Time frame: Through study completion, an average of two months
Pharmacodynamics: Associations between the PD parameters and infection rate
Time frame: Through study completion, an average of two months
Results and safety
The study was stopped early (reason given: Interim analysis suggested that the trial, as designed, was not adequately powered to detect a therapeutic effect.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- 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.
Hal Landy, MD study director
Alopexx Pharmaceuticals, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 mg/kg single infusion of F598, 3 mg/kg single infusion of F598 and 10 mg/kg single infusion of F598 in people with Neisseria Gonorrhoeae, run by Alopexx Pharmaceuticals, LLC at 1 site in United States.
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 18 inclusion and 34 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 8 Feb 2019. 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 United States. 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 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?
The study was stopped early (reason given: Interim analysis suggested that the trial, as designed, was not adequately powered to detect a therapeutic effect.). Results are not available in the source record.
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?
Assess the efficacy of F598 in preventing an experimental urethral infection with N. gonorrhoeae (time frame: Through study completion, an average of two months). 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 8 Feb 2019.