Malaria,FalciparumPhase 4NCT06424002
The Impact RTS,S/AS01 Vaccine in School Aged Children RTS,S/AS01 Malaria Vaccine in School Aged Children
A Phase 4 study testing Mosquirixs and artemether-lumefantrine in people with Malaria,Falciparum, run by Kamuzu University of Health Sciences.
Trial summary
Across sub-Saharan Africa, school-age children bear an under-appreciated burden of malaria. An estimated 200 million school-age children are at risk of malaria and in many areas prevalence of infection exceeds 50%. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Mosquirixs and artemether-lumefantrine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Dec 2024
- Phase
- Phase 4
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pupils aged approximately 6 years to 15 years and enrolled in Standard 1 - 8 in the participating schools
- Planning to remain in the study area for 1 year
- Parental/guardian consent for child's participation and child assent if the child is 13 years of age or older
Who cannot join
- Pregnancy, defined based on menstrual history. Pupils who had their last menstrual period more than 6 weeks before enrollment will be excluded. This threshold was chosen considering that menstrual cycles are irregular in this age group
- Viral infections resulting in fever, chills, new loss of taste/smell and sore throat
- Known allergy or history of adverse reaction to antimalarial treatment or vaccines
- Chronic use of anti-malarial medication, azithromycin, or cotrimoxazole
- Enrollment in any other study
- Evidence of heart disease, HIV, or epilepsy
- Severe disability
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact, Feasibility Acceptability and Cost Effectiveness of the RTS,S/AS01 Malaria Vaccine in School Aged Children
Across sub-Saharan Africa, school-age children bear an under-appreciated burden of malaria. An estimated 200 million school-age children are at risk of malaria and in many areas prevalence of infection exceeds 50%. The high infection rates in this group serves as a source of onward parasite transmission, undermining elimination and control efforts. Furthermore, malaria illness and malaria-induced anemia in this age group lead to school absenteeism, and impaired cognitive function and classroom attention, ultimately resulting in reduced academic achievement. Although universal malaria interventions, such as insecticide treated nets (ITNs) and access to prompt diagnosis and treatment are available to school-age children, this age group is the least likely to benefit from these interventions. Furthermore, efficacy of these approaches may be compromised by increasing anti-malarial drug and insecticide resistance. A malaria vaccine could help to avert the burden of malaria in this age group.
The RTS,S/AS01 malaria vaccine has recently been recommended for vaccination of young children (< 24 months) by the World health organization (WHO) after a Phase 3 trial and an implementation trial showed that the vaccine had moderate but significant efficacy to prevent clinical and severe malaria in young children. Previous randomized trials suggest that the vaccine is safe for older children. However, efficacy of the vaccine has never been assessed in school age children. Kamuzu University of Health Sciences in partnership with the Malawian Ministry of Health seeks to evaluate the efficacy of the newly introduced RTSS/AS01 malaria vaccine in school aged children. The study hypothesizes that vaccination will decrease the morbidity and transmission of malaria, as well as improve school absenteeism and educational outcomes.
Read the detailed description
This study will be an individual randomized open-label clinical trial to assess the impact, feasibility, acceptability and cost effectiveness of the RTS,S/AS01 vaccine in school-aged children in a malaria endemic environment.
A total of 5400 children aged 6 to 15 years who are attending standards 1-8 in five schools in rural (Machinga) district of Malawi will be randomized to one of the four intervention arms: RTS,S/AS01 vaccine only (RTS,S-only), RTS,S/AS01 vaccine plus an effective antimalarial (artemether-lumefantrine) at the start of the study (RTS,S+AL), artemether-lumefantrine only (AL-only) and a control group that receives only Vitamin A at the start of the study (VIT-A). After obtaining consent from guardians and assent from children older than 13 years of age, participating children will be randomly allocated in a 1:1:1:1 ratio into the intervention arms. Randomization will be stratified by classroom and school. Additionally, two siblings of a subset of 1000 children receiving the vaccine will be enrolled to evaluate the indirect effect of vaccination.
All children will be followed for up to 12 months after vaccination. Clinical malaria will be ascertained through passive case detection (PCD), and attendance and education outcomes will be ascertained through school records. PCD will conducted using the Learner Treatment Kit program platform, a school-based malaria diagnosis and treatment program that the Ministry of Health and Education are currently supporting across the selected schools. Through PCD, the safety of the interventions will also be monitored.
In a subset of 1000 enrolled in the study (250 per intervention arm) and two of their siblings will also be followed in three pre-scheduled visits, the active case detection (ACD) cohort in which the investigators will evaluate outcomes including the direct effect of the vaccine on malaria subclinical infection and the indirect effect of the vaccine. Children will be selected for this cohort randomly, stratifying the samples by school and four age strata (6-7 years, 8-9 years, 10-12 years, 13-15 years). Participants will be invited to visit a health center at baseline, i.e., before the interventions are administered, one month, six months, and 12 months after the end of the primary regimen of RTS,S/AS01. At each of these visits, capillary blood (~500 µl) will be collected through finger pricks for a dry blood spot, from which malaria quantitative polymerase chain reactions (qPCRs) will be performed to detect asexual parasites. In addition, one drop of blood will be used to measure hemoglobin concentrations. The remaining blood will be stored In 500 children enrolled in the ACD cohort and receiving vaccination, 6 mL of venous blood will be collected to evaluate immunological outcomes. These children will be randomly selected among those receiving RTS, S/AS01 (200 RTSS+AL and 200 RTSS-only) in four schools (50 X 2 intervention groups in each school), and the 4 age strata (~ 12 per age strata in each school and intervention group).
Feasibility, acceptability and cost data will be collected through interviews with all study stakeholders: learners, parents, teachers, community leaders, and district and national policy makers.
- Conditions
- Malaria,Falciparum
- Being tested
- Mosquirixs, artemether-lumefantrine
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosquirixsBiological
RTS,S is a subunit vaccine that includes a portion of the circumsporozoite protein (CSP) co-expressed with Hepatitis B surface antigen. The adjuvant is AS01. Three doses of the vaccine will be administered, each with one month interval.
artemether-lumefantrineDrug
A therapeutic dose of artemether-lumefantrine (20 mg of artemether and 120 mg of lumefantrine) will be given twice a day for 3 days based on the weight of the child as per treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| RTS,S/AS01 Vaccine | Experimental | Three doses of the vaccine will be administered, each with one month interval. RTS,S is a subunit vaccine that includes a portion of the circumsporozoite protein (CSP) co-expressed with Hepatitis B surface antigen. The adjuvant is AS01. Receives: Biological: Mosquirixs |
| RTS,S/AS01 Vaccine plus artemether-lumefantrine | Experimental | RTS,S/AS01 Vaccine will be provided with a therapeutic dose of artemether-lumefantrine (20 mg of artemether and 120 mg of lumefantrine). Artemether-lumefantrine will be given twice a day for 3 days based on the weight of the child as per treatment guidelines. Receives: Biological: Mosquirixs; Drug: artemether-lumefantrine |
| Artemether-lumefantrine only | Experimental | A therapeutic dose of artemether-lumefantrine will be given twice a day for 3 days based on the weight of the child as per treatment guidelines. Receives: Drug: artemether-lumefantrine |
| Vitamin A | No intervention | This is the control group where Vitamin A will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled school children with clinical malaria incident events throughout the study period (PCD).
Based on symptoms of malaria plus a positive malaria rapid diagnostic test. A bood slide will also be collected for future assessment for malaria parasites
Measured: During 18 months of follow up, when the child presents with symptoms of malaria within 48 hours at the leaner treatment kit (LTK) program which is run by teachers
Proportion of enrolled school children that are daily absent from class throughout the study period (using electronic classroom registers)
This will be based on electronic classroom registers
Measured: During 18 months of follow up, a daily register will be administered to record school attendance
Secondary outcomes (6)
Proportion of enrolled school children who pass their examinations at the end of the year and proceed to the next class (Pupil's passing fraction based on classroom records)
Pass rate based on classroom records
Measured: During 18 months of follow up, classroom records will record children passing end of year examinations
Proportion of enrolled school children with clinical malaria incident events throughout the study period (ACD)
Based on symptoms of malaria plus a positive malaria rapid diagnostic test. A bood slide will also be collected for future assessment for malaria parasites
Measured: During 18 months of follow up, clinical malaria will be assessed during sick visits (PCD) and during active case detection
Proportion of enrolled school children with P. falciparum infections during the study period (ACD).
Based dried blood spot (DBS) samples from index child
Measured: During 18 months of follow up, malaria infection will be assessed during the ACD visits
Proportion of children with low levels of hemoglobin levels (hb<11g/dl) during the study period (ACD).
As measured by hemocue machines
Measured: At baseline, midline, endline and during ACD visits, hemoglobin levels will be measured during the 18 months follow up period
Proportion of siblings of enrolled children with P. falciparum infections at the beginning and end of the study period (indirect or "spill over" effect) (ACD)
Based DBS samples from siblings of index child
Measured: During 18 months of follow up, malaria infection will be assessed during the ACD visits
Levels of antibodies against N-4-azido-2-nitrophenylpyridoxyl-5-phosphate (NANP) and CSP
Magnitude of immunoglobulin G (IgG) against NANP. 2. Geometric mean of magnitude of antibodies against the two antigens, as well as avidity, and fractional catabolic rate (FcR) binding activity over time.
Measured: At endline and during ACD visits, levels of antibodies will be measured during 18 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kamuzu University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malawi, Boston University, Michigan State University
- Responsible party
- Sponsor
- Investigators
- Don P Mathanga, PhD, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424002
- Sponsor's protocol ID
- P.09/22/3771
- Status last verified
- May 2024
- First submitted
- 22 Feb 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under this proposal, Investigators will de-identify all the data intended for broader use, and all variables that could be used to deductively disclose the identity of individual subjects. Examples of data that will be removed include names, dates of birth, medical record numbers, telephone numbers, and locations of homes. All data will be sent to the approved Malawi government data repository center for safe keeping and will also be made available through NIH-supported portals for wide dissemination and access. Any data shared will be subject to Malawi government conditions of use governing access to the public release of data, including restrictions against attempting to identify study participants, destruction of data after analyses are completed, reporting responsibilities, restrictions on redistribution of data to third parties, and proper acknowledgement of data source.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact, Feasibility Acceptability and Cost Effectiveness of the RTS,S/AS01 Malaria Vaccine in School Aged Children
- ClinicalTrials.gov ID
- NCT06424002
- Acronym / sponsor ID
- P.09/22/3771
- Conditions
- Malaria,Falciparum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Kamuzu University of Health SciencesUniversity, hospital or other
- Collaborators
- Ministry of Health, Malawi, Boston University, Michigan State University
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 May 2024 (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.
Across sub-Saharan Africa, school-age children bear an under-appreciated burden of malaria. An estimated 200 million school-age children are at risk of malaria and in many areas prevalence of infection exceeds 50%. The high infection rates in this group serves as a source of onward parasite transmission, undermining elimination and control efforts. Furthermore, malaria illness and malaria-induced anemia in this age group lead to school absenteeism, and impaired cognitive function and classroom attention, ultimately resulting in reduced academic achievement. Although universal malaria interventions, such as insecticide treated nets (ITNs) and access to prompt diagnosis and treatment are available to school-age children, this age group is the least likely to benefit from these interventions. Furthermore, efficacy of these approaches may be compromised by increasing anti-malarial drug and insecticide resistance. A malaria vaccine could help to avert the burden of malaria in this age group.
The RTS,S/AS01 malaria vaccine has recently been recommended for vaccination of young children (< 24 months) by the World health organization (WHO) after a Phase 3 trial and an implementation trial showed that the vaccine had moderate but significant efficacy to prevent clinical and severe malaria in young children. Previous randomized trials suggest that the vaccine is safe for older children. However, efficacy of the vaccine has never been assessed in school age children. Kamuzu University of Health Sciences in partnership with the Malawian Ministry of Health seeks to evaluate the efficacy of the newly introduced RTSS/AS01 malaria vaccine in school aged children. The study hypothesizes that vaccination will decrease the morbidity and transmission of malaria, as well as improve school absenteeism and educational outcomes.
Detailed description
This study will be an individual randomized open-label clinical trial to assess the impact, feasibility, acceptability and cost effectiveness of the RTS,S/AS01 vaccine in school-aged children in a malaria endemic environment.
A total of 5400 children aged 6 to 15 years who are attending standards 1-8 in five schools in rural (Machinga) district of Malawi will be randomized to one of the four intervention arms: RTS,S/AS01 vaccine only (RTS,S-only), RTS,S/AS01 vaccine plus an effective antimalarial (artemether-lumefantrine) at the start of the study (RTS,S+AL), artemether-lumefantrine only (AL-only) and a control group that receives only Vitamin A at the start of the study (VIT-A). After obtaining consent from guardians and assent from children older than 13 years of age, participating children will be randomly allocated in a 1:1:1:1 ratio into the intervention arms. Randomization will be stratified by classroom and school. Additionally, two siblings of a subset of 1000 children receiving the vaccine will be enrolled to evaluate the indirect effect of vaccination.
All children will be followed for up to 12 months after vaccination. Clinical malaria will be ascertained through passive case detection (PCD), and attendance and education outcomes will be ascertained through school records. PCD will conducted using the Learner Treatment Kit program platform, a school-based malaria diagnosis and treatment program that the Ministry of Health and Education are currently supporting across the selected schools. Through PCD, the safety of the interventions will also be monitored.
In a subset of 1000 enrolled in the study (250 per intervention arm) and two of their siblings will also be followed in three pre-scheduled visits, the active case detection (ACD) cohort in which the investigators will evaluate outcomes including the direct effect of the vaccine on malaria subclinical infection and the indirect effect of the vaccine. Children will be selected for this cohort randomly, stratifying the samples by school and four age strata (6-7 years, 8-9 years, 10-12 years, 13-15 years). Participants will be invited to visit a health center at baseline, i.e., before the interventions are administered, one month, six months, and 12 months after the end of the primary regimen of RTS,S/AS01. At each of these visits, capillary blood (~500 µl) will be collected through finger pricks for a dry blood spot, from which malaria quantitative polymerase chain reactions (qPCRs) will be performed to detect asexual parasites. In addition, one drop of blood will be used to measure hemoglobin concentrations. The remaining blood will be stored In 500 children enrolled in the ACD cohort and receiving vaccination, 6 mL of venous blood will be collected to evaluate immunological outcomes. These children will be randomly selected among those receiving RTS, S/AS01 (200 RTSS+AL and 200 RTSS-only) in four schools (50 X 2 intervention groups in each school), and the 4 age strata (~ 12 per age strata in each school and intervention group).
Feasibility, acceptability and cost data will be collected through interviews with all study stakeholders: learners, parents, teachers, community leaders, and district and national policy makers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RTS,S/AS01 Vaccine | Experimental | Biological: MosquirixsThree doses of the vaccine will be administered, each with one month interval. RTS,S is a subunit vaccine that includes a portion of the circumsporozoite protein (CSP) co-expressed with Hepatitis B surface antigen. The adjuvant is AS01. |
| RTS,S/AS01 Vaccine plus artemether-lumefantrine | Experimental | Biological: Mosquirixs, Drug: artemether-lumefantrineRTS,S/AS01 Vaccine will be provided with a therapeutic dose of artemether-lumefantrine (20 mg of artemether and 120 mg of lumefantrine). Artemether-lumefantrine will be given twice a day for 3 days based on the weight of the child as per treatment guidelines. |
| Artemether-lumefantrine only | Experimental | Drug: artemether-lumefantrineA therapeutic dose of artemether-lumefantrine will be given twice a day for 3 days based on the weight of the child as per treatment guidelines. |
| Vitamin A | No intervention | –This is the control group where Vitamin A will be given. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pupils aged approximately 6 years to 15 years and enrolled in Standard 1 - 8 in the participating schools
- Planning to remain in the study area for 1 year
- Parental/guardian consent for child's participation and child assent if the child is 13 years of age or older
Key exclusion criteria (7 listed)
- Pregnancy, defined based on menstrual history. Pupils who had their last menstrual period more than 6 weeks before enrollment will be excluded. This threshold was chosen considering that menstrual cycles are irregular in this age group
- Viral infections resulting in fever, chills, new loss of taste/smell and sore throat
- Known allergy or history of adverse reaction to antimalarial treatment or vaccines
- Chronic use of anti-malarial medication, azithromycin, or cotrimoxazole
- Enrollment in any other study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosquirixsRTS,S is a subunit vaccine that includes a portion of the circumsporozoite protein (CSP) co-expressed with Hepatitis B surface antigen. The adjuvant is AS01. Three doses of the vaccine will be administered, each with one month interval. | Biological | RTS,S/AS01 Vaccine, RTS,S/AS01 Vaccine plus artemether-lumefantrine |
| artemether-lumefantrineA therapeutic dose of artemether-lumefantrine (20 mg of artemether and 120 mg of lumefantrine) will be given twice a day for 3 days based on the weight of the child as per treatment guidelines. | Drug | Artemether-lumefantrine only, RTS,S/AS01 Vaccine plus artemether-lumefantrine |
Primary outcome
Proportion of enrolled school children with clinical malaria incident events throughout the study period (PCD).
Time frame: During 18 months of follow up, when the child presents with symptoms of malaria within 48 hours at the leaner treatment kit (LTK) program which is run by teachers
Based on symptoms of malaria plus a positive malaria rapid diagnostic test. A bood slide will also be collected for future assessment for malaria parasites
Proportion of enrolled school children that are daily absent from class throughout the study period (using electronic classroom registers)
Time frame: During 18 months of follow up, a daily register will be administered to record school attendance
This will be based on electronic classroom registers
6 secondary outcomes
Proportion of enrolled school children who pass their examinations at the end of the year and proceed to the next class (Pupil's passing fraction based on classroom records)
Time frame: During 18 months of follow up, classroom records will record children passing end of year examinations
Proportion of enrolled school children with clinical malaria incident events throughout the study period (ACD)
Time frame: During 18 months of follow up, clinical malaria will be assessed during sick visits (PCD) and during active case detection
Proportion of enrolled school children with P. falciparum infections during the study period (ACD).
Time frame: During 18 months of follow up, malaria infection will be assessed during the ACD visits
Proportion of children with low levels of hemoglobin levels (hb<11g/dl) during the study period (ACD).
Time frame: At baseline, midline, endline and during ACD visits, hemoglobin levels will be measured during the 18 months follow up period
Proportion of siblings of enrolled children with P. falciparum infections at the beginning and end of the study period (indirect or "spill over" effect) (ACD)
Time frame: During 18 months of follow up, malaria infection will be assessed during the ACD visits
Levels of antibodies against N-4-azido-2-nitrophenylpyridoxyl-5-phosphate (NANP) and CSP
Time frame: At endline and during ACD visits, levels of antibodies will be measured during 18 months of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Yes. Under this proposal, Investigators will de-identify all the data intended for broader use, and all variables that could be used to deductively disclose the identity of individual subjects. Examples of data that will be removed include names, dates of birth, medical record numbers, telephone numbers, and locations of homes. All data will be sent to the approved Malawi government data repository center for safe keeping and will also be made available through NIH-supported portals for wide dissemination and access. Any data shared will be subject to Malawi government conditions of use governing access to the public release of data, including restrictions against attempting to identify study participants, destruction of data after analyses are completed, reporting responsibilities, restrictions on redistribution of data to third parties, and proper acknowledgement of data source.
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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.
Don P Mathanga, PhD principal investigator
Kamuzu University of Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mosquirixs and artemether-lumefantrine in people with Malaria,Falciparum, run by Kamuzu University of Health Sciences.
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 7 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: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Don P Mathanga, PhD (+2651871911, dmathang@mac.kuhes.ac.mw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of enrolled school children with clinical malaria incident events throughout the study period (PCD). (time frame: During 18 months of follow up, when the child presents with symptoms of malaria within 48 hours at the leaner treatment kit (LTK) program which is run by teachers). 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?
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 21 May 2024.