Uncomplicated Plasmodium Falciparum MalariaPhase 2/33ACTNCT05764746
Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial
A Phase 2/3 study testing Artemether-lumefantrine and Amodiaquine Drug Combination, Artemether-lumefantrine then Artesunate amodiaquine and Artemether-lumefantrine in people with Uncomplicated Plasmodium Falciparum Malaria, run by Muhimbili University of Health and Allied Sciences at 2 sites in Tanzania.
Trial summary
Background: Artemisinin resistance has emerged in parts of Southeast Asia, and there are reports in Africa of reduced susceptibility of Plasmodium falciparum parasites against artemisinin-based combination therapy (ACT). No new drugs are available in the pipeline to replace ACTs in case they fail. Read more about this study
- Who is it for?
- Ages 6 to 120 months
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- Artemether-lumefantrine and Amodiaquine Drug Combination, Artemether-lumefantrine then Artesunate amodiaquine and Artemether-lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesTanzania
- Study dates
- 1 May 2023to 1 Jan 2025
- Phase
- Phase 2/3
- 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 120 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 6 - 120 months
- Weight ≥ 5 kg
- Body temperature ≥37.5°C or history of fever in the last 24 hours
- Microscopy confirmed P. falciparum mono-infection
- Parasitemia level of 1000-200000/μL
- Ability to swallow oral medication
- Ability and willingness to abide by the study protocol and the stipulated follow-up visits
- A written proxy informed consent from a parent/guardian
Who cannot join
- Children aged below 6 months will not be included in the study because ACTs are contraindicated in this group.
- Evidence of severe malaria or danger signs
- Known allergy to trial medicines
- Reported antimalarial intake ≤2 weeks
- Haemoglobin <5 g/dL
- Blood transfusion within last 90 days
- Febrile condition other than malaria
- Known underlying chronic or severe disease (including severe malnutrition).
Trial locations and contacts
2 sites in 1 country.
Tanzania2 sites
Kibindu
Bagamoyo, Dar esSalaam, 255
Yombo Dispensary
Bagamoyo, Yombo, +255
About this study
Official title: Can Triple Artemisinin-based Combination Therapy for Treatment of Uncomplicated Plasmodium Falciparum Malaria, Delay Drug Resistance Development of Plasmodium Falciparum in Tanzania: a Randomized Three Arm Clinical Trial
Background: Artemisinin resistance has emerged in parts of Southeast Asia, and there are reports in Africa of reduced susceptibility of Plasmodium falciparum parasites against artemisinin-based combination therapy (ACT). No new drugs are available in the pipeline to replace ACTs in case they fail.
This study aims to assess whether a sequential administration of triple ACTs with different partner-drugs can improve the efficacy of ACT for treatment of uncomplicated malaria.
Read more
Methods: A health facility-based, three-arm partially blinded randomized clinical trial will be conducted to assess efficacy and safety of a sequential administration of artemether-lumefantrine followed immediately by artesunate-amodiaquine (AL+ASAQ) or artemether-lumefantrine with by amodiaquine (AL+AQ) compared to artemether-lumefantrine plus placebo (AL+PBO). Eligible children aged 6 - 120 months and with microscopy confirmed uncomplicated P. falciparum malaria will be enrolled, administered with trial medicines and followed-up at 0 (just prior to first drug intake) and 8 hours on day 0, 12 hourly on days 1, 2, 3, 4, 5, followed by once daily on days 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28, 35, 42 and 56 for clinical and laboratory evaluations. Clinical evaluation will involve assessment of signs and symptoms related to the disease and or trial medicine during follow-up. Laboratory evaluation will include microscopic determination of presence of malaria parasites and species, hemoglobin level, molecular analysis for markers of drug resistance and to differentiate recrudescence from new infection. The primary outcome will be crude recurrent parasitemia by day 42 in the respective arms.
Expected outcomes: The findings will give an insight on whether 3 ACTs are more efficacious than the use of first-line regimen alone, and are tolerable for treatment of uncomplicated falciparum malaria.
- Being tested
- Artemether-lumefantrine and Amodiaquine Drug Combination, Artemether-lumefantrine then Artesunate amodiaquine, Artemether-lumefantrine
- Keywords
- Artemisinin-based Combination Therapy, Plasmodium falciparum, Uncomplicated malaria
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine and Amodiaquine Drug CombinationDrug
Also called AL+AQ
AL and AQ will be given together for three days then followed by placebo for three days
Artemether-lumefantrine then Artesunate amodiaquineDrug
Also called AL then ASAQ
AL will be given twice a day for three days then followed by artesunate amodiaquine once a day for three days
Artemether-lumefantrineDrug
Also called AL + Placebo
This will be the comparator arm as standard treatment, where only AL will be given twice a day for three days then placebo for three days
| Study group | Role | What they receive |
|---|---|---|
| Artemether-lumefantrine followed by artesunate amodiaquine | Experimental | a standard 3-days dosage, twice a day course of Artemether-Lumefantrine (20/120mg) immediately followed by a standard 3-days, once a day course of Artesunate-Amodiaquine (40base) Receives: Drug: Artemether-lumefantrine then Artesunate amodiaquine |
| Artemether-lumefantrine with Amodiaquine | Experimental | a standard 3-days dosage of Artemether-Lumefantrine (20/120mg) given together with Amodiaquine hydrocloride(40 base) followed by placebo for another 3 days; Receives: Drug: Artemether-lumefantrine and Amodiaquine Drug Combination |
| Artemether-Lumefantrine alone | Active comparator | a standard 3-days dosage of Artemether-Lumefantrine (20/120mg) followed by placebo for another 3 days Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crude recurrent parasitemia by day 42 in the respective arms
Laboratory assessment of parasitemia using light microscopy performed at 42nd day of follow up will be the primary outcome assessing the differences in proportion of patients with recurrent parasitemia.
Measured: 42nd day since enrollment
Secondary outcomes (2)
PCR adjusted cure rates by day 28, 42 and 56.
Assessment of cure rate as determined by parasitemia to distinguish recrudescence and reinfections
Measured: Through study completion, an average of 1 year
Crude recurrent parasitemia by day 28 and 56 in the respective arms
Laboratory assessment of parasitemia using light microscopy performed at day 28 and the last day (56th) of follow up will be the primary outcome assessing the differences in proportion of patients with recurrent parasitemia.
Measured: Day 28 and day 56 since enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 May 2023
- Primary completion30 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated Plasmodium Falciparum MalariaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A health facility-based, three-arm partially blinded randomized clinical trial will be conducted to assess efficacy and safety of a sequential administration of artemether-lumefantrine followed immediately by artesunate-amodiaquine (AL+ASAQ) or artemether-lumefantrine with by amodiaquine (AL+AQ) compared to artemether-lumefantrine plus placebo (AL+PBO).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Uppsala University
- Responsible party
- Principal investigator, Billy Ngasala, Uppsala University
- Investigators
- Billy E Ngasala, PhD, Principal investigator, Muhimbili University of Health and Allied SciencesAndreas Mårtensson, PhD, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764746
- Sponsor's protocol ID
- 3ACT-2023
- Acronym
- 3ACT
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holmstrom O, Linder N, Ngasala B, Martensson A, Linder E, Lundin M, Moilanen H, Suutala A, Diwan V, Lundin J. Point-of-care mobile digital microscopy and deep learning for the detection of soil-transmitted helminths and Schistosoma haematobium. Glob Health Action. 2017 Jun;10(sup3):1337325. doi: 10.1080/16549716.2017.1337325.
PubMed 28838305Smit MR, Ochomo EO, Aljayyoussi G, Kwambai TK, Abong'o BO, Chen T, Bousema T, Slater HC, Waterhouse D, Bayoh NM, Gimnig JE, Samuels AM, Desai MR, Phillips-Howard PA, Kariuki SK, Wang D, Ward SA, Ter Kuile FO. Safety and mosquitocidal efficacy of high-dose ivermectin when co-administered with dihydroartemisinin-piperaquine in Kenyan adults with uncomplicated malaria (IVERMAL): a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2018 Jun;18(6):615-626. doi: 10.1016/S1473-3099(18)30163-4. Epub 2018 Mar 27.
PubMed 29602751Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009 Jul 30;361(5):455-67. doi: 10.1056/NEJMoa0808859.
PubMed 19641202Leang R, Taylor WR, Bouth DM, Song L, Tarning J, Char MC, Kim S, Witkowski B, Duru V, Domergue A, Khim N, Ringwald P, Menard D. Evidence of Plasmodium falciparum Malaria Multidrug Resistance to Artemisinin and Piperaquine in Western Cambodia: Dihydroartemisinin-Piperaquine Open-Label Multicenter Clinical Assessment. Antimicrob Agents Chemother. 2015 Aug;59(8):4719-26. doi: 10.1128/AAC.00835-15. Epub 2015 May 26.
PubMed 26014949Mwaiswelo R, Ngasala B, Gil JP, Malmberg M, Jovel I, Xu W, Premji Z, Mmbando BP, Bjorkman A, Martensson A. Sustained High Cure Rate of Artemether-Lumefantrine against Uncomplicated Plasmodium falciparum Malaria after 8 Years of Its Wide-Scale Use in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2017 Aug;97(2):526-532. doi: 10.4269/ajtmh.16-0780.
PubMed 28829723Mwaiswelo R, Ngasala B, Jovel I, Xu W, Larsson E, Malmberg M, Gil JP, Premji Z, Mmbando BP, Martensson A. Prevalence of and Risk Factors Associated with Polymerase Chain Reaction-Determined Plasmodium falciparum Positivity on Day 3 after Initiation of Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2019 May;100(5):1179-1186. doi: 10.4269/ajtmh.18-0729.
PubMed 30860013
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Triple Artemisinin-based Combination Therapy for Treatment of Uncomplicated Plasmodium Falciparum Malaria, Delay Drug Resistance Development of Plasmodium Falciparum in Tanzania: a Randomized Three Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05764746
- Acronym / sponsor ID
- 3ACT / 3ACT-2023
- Keywords
- Artemisinin-based Combination Therapy, Plasmodium falciparum, Uncomplicated malaria
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Muhimbili University of Health and Allied SciencesUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Uppsala University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 Mar 2023 (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.
Background: Artemisinin resistance has emerged in parts of Southeast Asia, and there are reports in Africa of reduced susceptibility of Plasmodium falciparum parasites against artemisinin-based combination therapy (ACT). No new drugs are available in the pipeline to replace ACTs in case they fail.
This study aims to assess whether a sequential administration of triple ACTs with different partner-drugs can improve the efficacy of ACT for treatment of uncomplicated malaria.
Methods: A health facility-based, three-arm partially blinded randomized clinical trial will be conducted to assess efficacy and safety of a sequential administration of artemether-lumefantrine followed immediately by artesunate-amodiaquine (AL+ASAQ) or artemether-lumefantrine with by amodiaquine (AL+AQ) compared to artemether-lumefantrine plus placebo (AL+PBO). Eligible children aged 6 - 120 months and with microscopy confirmed uncomplicated P. falciparum malaria will be enrolled, administered with trial medicines and followed-up at 0 (just prior to first drug intake) and 8 hours on day 0, 12 hourly on days 1, 2, 3, 4, 5, followed by once daily on days 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28, 35, 42 and 56 for clinical and laboratory evaluations. Clinical evaluation will involve assessment of signs and symptoms related to the disease and or trial medicine during follow-up. Laboratory evaluation will include microscopic determination of presence of malaria parasites and species, hemoglobin level, molecular analysis for markers of drug resistance and to differentiate recrudescence from new infection. The primary outcome will be crude recurrent parasitemia by day 42 in the respective arms.
Expected outcomes: The findings will give an insight on whether 3 ACTs are more efficacious than the use of first-line regimen alone, and are tolerable for treatment of uncomplicated falciparum malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A health facility-based, three-arm partially blinded randomized clinical trial will be conducted to assess efficacy and safety of a sequential administration of artemether-lumefantrine followed immediately by artesunate-amodiaquine (AL+ASAQ) or artemether-lumefantrine with by amodiaquine (AL+AQ) compared to artemether-lumefantrine plus placebo (AL+PBO).
| Arm | Type | Receives |
|---|---|---|
| Artemether-lumefantrine followed by artesunate amodiaquine | Experimental | Drug: Artemether-lumefantrine then Artesunate amodiaquinea standard 3-days dosage, twice a day course of Artemether-Lumefantrine (20/120mg) immediately followed by a standard 3-days, once a day course of Artesunate-Amodiaquine (40base) |
| Artemether-lumefantrine with Amodiaquine | Experimental | Drug: Artemether-lumefantrine and Amodiaquine Drug Combinationa standard 3-days dosage of Artemether-Lumefantrine (20/120mg) given together with Amodiaquine hydrocloride(40 base) followed by placebo for another 3 days; |
| Artemether-Lumefantrine alone | Active comparator | Drug: Artemether-lumefantrinea standard 3-days dosage of Artemether-Lumefantrine (20/120mg) followed by placebo for another 3 days |
Who may qualify
- Ages
- 6 to 120 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age from 6 - 120 months
- Weight ≥ 5 kg
- Body temperature ≥37.5°C or history of fever in the last 24 hours
- Microscopy confirmed P. falciparum mono-infection
- Parasitemia level of 1000-200000/μL
Key exclusion criteria (8 listed)
- Children aged below 6 months will not be included in the study because ACTs are contraindicated in this group.
- Evidence of severe malaria or danger signs
- Known allergy to trial medicines
- Reported antimalarial intake ≤2 weeks
- Haemoglobin <5 g/dL
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 |
|---|---|---|
| Artemether-lumefantrine and Amodiaquine Drug CombinationAlso: AL+AQAL and AQ will be given together for three days then followed by placebo for three days | Drug | Artemether-lumefantrine with Amodiaquine |
| Artemether-lumefantrine then Artesunate amodiaquineAlso: AL then ASAQAL will be given twice a day for three days then followed by artesunate amodiaquine once a day for three days | Drug | Artemether-lumefantrine followed by artesunate amodiaquine |
| Artemether-lumefantrineAlso: AL + PlaceboThis will be the comparator arm as standard treatment, where only AL will be given twice a day for three days then placebo for three days | Drug | Artemether-Lumefantrine alone |
Primary outcome
Crude recurrent parasitemia by day 42 in the respective arms
Time frame: 42nd day since enrollment
Laboratory assessment of parasitemia using light microscopy performed at 42nd day of follow up will be the primary outcome assessing the differences in proportion of patients with recurrent parasitemia.
2 secondary outcomes
PCR adjusted cure rates by day 28, 42 and 56.
Time frame: Through study completion, an average of 1 year
Crude recurrent parasitemia by day 28 and 56 in the respective arms
Time frame: Day 28 and day 56 since enrollment
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 23 Sep 2026.
- Background: PubMed 28838305Holmstrom O, Linder N, Ngasala B, Martensson A, Linder E, Lundin M, Moilanen H, Suutala A, Diwan V, Lundin J. Point-of-care mobile digital microscopy and deep learning for the detection of soil-transmitted helminths and Schistosoma haematobium. Glob Health Action. 2017 Jun;10(sup3):1337325. doi: 10.1080/16549716.2017.1337325.
- Background: PubMed 29602751Smit MR, Ochomo EO, Aljayyoussi G, Kwambai TK, Abong'o BO, Chen T, Bousema T, Slater HC, Waterhouse D, Bayoh NM, Gimnig JE, Samuels AM, Desai MR, Phillips-Howard PA, Kariuki SK, Wang D, Ward SA, Ter Kuile FO. Safety and mosquitocidal efficacy of high-dose ivermectin when co-administered with dihydroartemisinin-piperaquine in Kenyan adults with uncomplicated malaria (IVERMAL): a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2018 Jun;18(6):615-626. doi: 10.1016/S1473-3099(18)30163-4. Epub 2018 Mar 27.
- Background: PubMed 19641202Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009 Jul 30;361(5):455-67. doi: 10.1056/NEJMoa0808859.
- Background: PubMed 26014949Leang R, Taylor WR, Bouth DM, Song L, Tarning J, Char MC, Kim S, Witkowski B, Duru V, Domergue A, Khim N, Ringwald P, Menard D. Evidence of Plasmodium falciparum Malaria Multidrug Resistance to Artemisinin and Piperaquine in Western Cambodia: Dihydroartemisinin-Piperaquine Open-Label Multicenter Clinical Assessment. Antimicrob Agents Chemother. 2015 Aug;59(8):4719-26. doi: 10.1128/AAC.00835-15. Epub 2015 May 26.
- Background: PubMed 28829723Mwaiswelo R, Ngasala B, Gil JP, Malmberg M, Jovel I, Xu W, Premji Z, Mmbando BP, Bjorkman A, Martensson A. Sustained High Cure Rate of Artemether-Lumefantrine against Uncomplicated Plasmodium falciparum Malaria after 8 Years of Its Wide-Scale Use in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2017 Aug;97(2):526-532. doi: 10.4269/ajtmh.16-0780.
- Background: PubMed 30860013Mwaiswelo R, Ngasala B, Jovel I, Xu W, Larsson E, Malmberg M, Gil JP, Premji Z, Mmbando BP, Martensson A. Prevalence of and Risk Factors Associated with Polymerase Chain Reaction-Determined Plasmodium falciparum Positivity on Day 3 after Initiation of Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2019 May;100(5):1179-1186. doi: 10.4269/ajtmh.18-0729.
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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.
Billy E Ngasala, PhD principal investigator
Muhimbili University of Health and Allied Sciences
Andreas Mårtensson, PhD principal investigator
Muhimbili University of Health and Allied Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Artemether-lumefantrine and Amodiaquine Drug Combination, Artemether-lumefantrine then Artesunate amodiaquine and Artemether-lumefantrine in people with Uncomplicated Plasmodium Falciparum Malaria, run by Muhimbili University of Health and Allied Sciences at 2 sites in Tanzania.
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 8 inclusion and 8 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Crude recurrent parasitemia by day 42 in the respective arms (time frame: 42nd day since enrollment). 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 NCT05764746, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.