MalariaPhase 1NCT04072302
Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model
A Phase 1 study testing KAF156 in people with Malaria, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- KAF156
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2014to 29 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects,aged 18 to 40 years of age included and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests
Who cannot join
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Known history or current clinically significant ECG abnormalities or arrhythmias.
- Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, or other conditions which could interfere with the interpretation of the study results or compromise the health of the subjects.
- Sexually active males must use a condom during intercourse while taking drug and for al least 4 weeks after stopping study medication and should not father a child during this period.
- History of malaria or residence in a malaria-endemic area over a period of 6 months before study entry. - Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk or render the subject unable to meet requirements of the protocol.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
Seattle, Washington, 98109
About this study
Official title: A Two-part, Randomized, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model
This study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model.
- Conditions
- Malaria
- Being tested
- KAF156, Placebo
- Keywords
- Malaria, KAF156, P. falciparum
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAF156Drug
100 mg tablet, 20 mg tablet, 50 mg tablet
PlaceboDrug
100 mg tablet, 20 mg tablet, 50 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| KAF156 800 mg pre-challenge | Experimental | Single dose 800 mg KAF156 oral administration in healthy subjects, prior to exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: KAF156 |
| Placebo 800 mg pre-challenge | Placebo comparator | Single dose 800 mg placebo oral administration in healthy subjects, prior to exposure to P. falciiparum sporozoite-infected mosquitos Receives: Drug: Placebo |
| KAF156 800 mg post-challenge | Experimental | Single dose 800 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: KAF156 |
| Placebo 800 mg post-challenge | Placebo comparator | Single dose 800 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: Placebo |
| KAF156 300 mg post-challenge | Experimental | Single dose 300 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: KAF156 |
| Placebo 300 mg post-challenge | Placebo comparator | Single dose 300 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: Placebo |
| KAF156 100 mg post-challenge | Experimental | Single dose 100 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: KAF156 |
| Placebo 100 mg post-challenge | Placebo comparator | Single dose 100 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: Placebo |
| KAF156 20 mg post-challenge | Experimental | Single dose 20 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: KAF156 |
| Placebo 20 mg post-challenge | Placebo comparator | Single dose 20 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: Placebo |
| KAF156 50 mg post-challenge | Experimental | Single dose 50 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: KAF156 |
| Placebo 50 mg post-challenge | Placebo comparator | Single dose 50 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with parasitemia after single dose oral administration of KAF156 either prior to, or following, exposure to P. falciparum sporozoite-infected mosquitoes
The number of subjects that became infected with malaria at each dose
Measured: From Day 1 to Day 43
Relationship between pharmacokinetics (i.e., Maximum Plasma Concentration [Cmax], Area Under Curve [AUC]) of KAF156 and number of subjects with parasitemia, after oral administration of single descending doses of KAF156 in healthy subjects with CHMI
The exposure-response relationship of KAF156 was explored in a PK/PD model to relate drug exposure to prophylactic efficacy using standard statistical methods such as CART or non-linear regression. Summary statistics were also provided for the malaria incidence rate by cohort and treatment arm
Measured: From Day 1 to Day 43
Secondary outcomes (10)
Number of subjects with adverse events, serious adverse events, and death
All information obtained on adverse events will be displayed by arm, treatment, and subject. The number and percentage of subjects with adverse events will be tabulated by body system and preferred term with a breakdown by cohort and treatment.
Measured: From screening to Day 43
Pharmacokinetics of KAF156: Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate AUCinf
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate AUClast
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Area under teh plasma concentration-time curve from time zero to time 24 h (AUC0-24)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate AUC0-24
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Terminal elimination half life (T1/2)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate T1/2.
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Apparent systemic clearance from plasma following oral administration (CL/F)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate CL/F
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Apparent volume of distribution during the terminal phase following oral administration (Vz/F)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate Vz/F
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Observed maximum plasma concentration (Cmax)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate Cmax
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Time to reach the maximum concentration (Tmax)
KAF156 plasma concentration data will be listed by arm, subject, and sampling time point.
Descriptive summary statistics will be provided by arm and sampling time point. These values will be used to calculate Tmax
Measured: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Parasite growth Kinetics by qRT-PCR
Parasitemia levels as measured by qRT-PCR will be summarized and displayed graphically over time.
Measured: Pre-dose, days 7-23, Day 29, Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Sep 2014
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
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 MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072302
- Sponsor's protocol ID
- CKAF156X2202
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kublin JG, Murphy SC, Maenza J, Seilie AM, Jain JP, Berger D, Spera D, Zhao R, Soon RL, Czartoski JL, Potochnic MA, Duke E, Chang M, Vaughan A, Kappe SHI, Leong FJ, Pertel P, Prince WT; KAF156 Study Team. Safety, Pharmacokinetics, and Causal Prophylactic Efficacy of KAF156 in a Plasmodium falciparum Human Infection Study. Clin Infect Dis. 2021 Oct 5;73(7):e2407-e2414. doi: 10.1093/cid/ciaa952.
PubMed 32644127
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomized, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model
- ClinicalTrials.gov ID
- NCT04072302
- Acronym / sponsor ID
- CKAF156X2202
- Conditions
- Malaria
- Keywords
- Malaria, KAF156, P. falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 28 Aug 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 study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| KAF156 800 mg pre-challenge | Experimental | Drug: KAF156Single dose 800 mg KAF156 oral administration in healthy subjects, prior to exposure to P. falciparum sporozoite-infected mosquitos |
| Placebo 800 mg pre-challenge | Placebo comparator | Drug: PlaceboSingle dose 800 mg placebo oral administration in healthy subjects, prior to exposure to P. falciiparum sporozoite-infected mosquitos |
| KAF156 800 mg post-challenge | Experimental | Drug: KAF156Single dose 800 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| Placebo 800 mg post-challenge | Placebo comparator | Drug: PlaceboSingle dose 800 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| KAF156 300 mg post-challenge | Experimental | Drug: KAF156Single dose 300 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| Placebo 300 mg post-challenge | Placebo comparator | Drug: PlaceboSingle dose 300 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| KAF156 100 mg post-challenge | Experimental | Drug: KAF156Single dose 100 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| Placebo 100 mg post-challenge | Placebo comparator | Drug: PlaceboSingle dose 100 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| KAF156 20 mg post-challenge | Experimental | Drug: KAF156Single dose 20 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| Placebo 20 mg post-challenge | Placebo comparator | Drug: PlaceboSingle dose 20 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| KAF156 50 mg post-challenge | Experimental | Drug: KAF156Single dose 50 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
| Placebo 50 mg post-challenge | Placebo comparator | Drug: PlaceboSingle dose 50 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects,aged 18 to 40 years of age included and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests
Key exclusion criteria (6 listed)
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Known history or current clinically significant ECG abnormalities or arrhythmias.
- Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, or other conditions which could interfere with the interpretation of the study results or compromise the health of the subjects.
- Sexually active males must use a condom during intercourse while taking drug and for al least 4 weeks after stopping study medication and should not father a child during this period.
- History of malaria or residence in a malaria-endemic area over a period of 6 months before study entry. - Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk or render the subject unable to meet requirements of the protocol.
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 |
|---|---|---|
| KAF156100 mg tablet, 20 mg tablet, 50 mg tablet | Drug | KAF156 100 mg post-challenge, KAF156 20 mg post-challenge, KAF156 300 mg post-challenge, KAF156 50 mg post-challenge, KAF156 800 mg post-challenge, KAF156 800 mg pre-challenge |
| Placebo100 mg tablet, 20 mg tablet, 50 mg tablet | Drug | Placebo 100 mg post-challenge, Placebo 20 mg post-challenge, Placebo 300 mg post-challenge, Placebo 50 mg post-challenge, Placebo 800 mg post-challenge, Placebo 800 mg pre-challenge |
Primary outcome
Number of subjects with parasitemia after single dose oral administration of KAF156 either prior to, or following, exposure to P. falciparum sporozoite-infected mosquitoes
Time frame: From Day 1 to Day 43
The number of subjects that became infected with malaria at each dose
Relationship between pharmacokinetics (i.e., Maximum Plasma Concentration [Cmax], Area Under Curve [AUC]) of KAF156 and number of subjects with parasitemia, after oral administration of single descending doses of KAF156 in healthy subjects with CHMI
Time frame: From Day 1 to Day 43
The exposure-response relationship of KAF156 was explored in a PK/PD model to relate drug exposure to prophylactic efficacy using standard statistical methods such as CART or non-linear regression. Summary statistics were also provided for the malaria incidence rate by cohort and treatment arm
10 secondary outcomes
Number of subjects with adverse events, serious adverse events, and death
Time frame: From screening to Day 43
Pharmacokinetics of KAF156: Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Area under teh plasma concentration-time curve from time zero to time 24 h (AUC0-24)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Terminal elimination half life (T1/2)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Apparent systemic clearance from plasma following oral administration (CL/F)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Apparent volume of distribution during the terminal phase following oral administration (Vz/F)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Observed maximum plasma concentration (Cmax)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Pharmacokinetics of KAF156: Time to reach the maximum concentration (Tmax)
Time frame: Pre-dose, and Post-dose: 1 hour, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 96 hours, 144 hours, 110 hours, 216 hours, 240 hours
Parasite growth Kinetics by qRT-PCR
Time frame: Pre-dose, days 7-23, Day 29, Day 43
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 28 Aug 2019.
- Derived from this study: PubMed 32644127Kublin JG, Murphy SC, Maenza J, Seilie AM, Jain JP, Berger D, Spera D, Zhao R, Soon RL, Czartoski JL, Potochnic MA, Duke E, Chang M, Vaughan A, Kappe SHI, Leong FJ, Pertel P, Prince WT; KAF156 Study Team. Safety, Pharmacokinetics, and Causal Prophylactic Efficacy of KAF156 in a Plasmodium falciparum Human Infection Study. Clin Infect Dis. 2021 Oct 5;73(7):e2407-e2414. doi: 10.1093/cid/ciaa952.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 KAF156 in people with Malaria, run by Novartis Pharmaceuticals 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 1 inclusion and 6 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 28 Aug 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. 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 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 subjects with parasitemia after single dose oral administration of KAF156 either prior to, or following, exposure to P. falciparum sporozoite-infected mosquitoes (time frame: From Day 1 to Day 43). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072302, 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 28 Aug 2019.