Malaria,FalciparumPhase 3InSMART-schoolNCT03640403
Effectiveness and Safety of Intermittent Preventive Treatment for Malaria Using Either Dihydroartemisinin-piperaquine or Artesunate-amodiaquine in Reducing Malaria Related Morbidities and Improving Cognitive Ability in School-aged Children in Tanzania
A Phase 3 study testing Dihydroartemisinin-piperaquine and Artesunate-amodiaquine in people with Malaria,Falciparum and Anemia, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
Trial summary
Background: In high-transmission settings, up to 70% of school-aged children harbour malaria parasites which is mostly asymptomatic, thus, from an epidemiological point of view, they contribute significantly as reservoir to onward malaria transmission to others. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum, Anemia
- What is being tested?
- Dihydroartemisinin-piperaquine and Artesunate-amodiaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,555 participants
- Where
- 1 siteTanzania
- Study dates
- 26 Mar 2019to 31 Dec 2021
- Phase
- Phase 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Includes parental/guardian informed consent
- Assent by primary school children aged 11 years and above.
- Aged 5-15 years.
- Currently, lives within the pre-defined catchment area of Muheza District.
- Will remain within the same area throughout the study period (preferably class five and below).
Who cannot join
- Students at class 6 and 7
- Currently enrolled in another study or participated in another investigational drug study within the last 30 days.
- Known to have heart disease or a known cardiac ailment.
- Reports known hypersensitivity to the study drugs.
- Not willing to undergo all study procedures including physical examination and to provide blood samples as per this study protocol.
- Having clinical features of severe anaemia
Show all 10Show fewer
- Febrile due to non-malaria illness at the time of recruitment.
- Has apparent severe infection or any condition that requires hospitalization
- Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and SS sickle cell.
- Body weight < 14 k
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Intermittent Preventive Treatment for Malaria Using Either Dihydroartemisinin-piperaquine or Artesunate-amodiaquine in Reducing Malaria Related Morbidities and Improving Cognitive Ability in School-aged Children in Tanzania: A Controlled Randomised Trial
Background:
In high-transmission settings, up to 70% of school-aged children harbour malaria parasites which is mostly asymptomatic, thus, from an epidemiological point of view, they contribute significantly as reservoir to onward malaria transmission to others. In endemic areas, malaria accounts for around 50% of the mortality, 13-50% of all school absenteeism, and causes anaemia in approximately 85 million school-aged children of sub Saharan Africa that also impairs the cognitive development of children. Intermittent preventive treatment (IPT) of pregnant women as well as seasonal malaria chemoprevention in children under the age of five have been implemented in several sub-Saharan countries and have proven to be very effective. However, none of these IPT strategies is targeting school children. A clinical trial is being conducted to expand the IPT by testing effectiveness and safety of two antimalarial drugs Dihydroartemisinin-piperaquine (DP) and Artesunate-amodiaquine (ASAQ) in preventing malaria related morbidity in school aged children (IPTsc) living in high endemic areas.
Read more
Methods:
A randomized, open label, controlled trial will enrol 1602 school children aged 5-15 years, who will receive either DP or ASAQ or control (no drug ), using a "balanced block design" with the "standard of care" arm as reference. The interventional treatments are given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. All study-arms receive bed nets, early diagnosis and care for malaria, and praziquantel and albendazole as mass treatment for helminthiasis. The primary endpoint are change from baseline in mean haemoglobin concentration at months 12 and 20 of follow-up and clinical malaria incidence from month 0 till months 12 and 20 of follow up. Adverse events will be monitored throughout the study. Mixed design methods will be used to assess the acceptability, cost-effectiveness and feasibility of this IPTsc as part of a more comprehensive school children health package.
Discussion:
The national school health programme (NSHP), Tanzania, combines schistosomiasis and soil transmitted helminthes (STH) control package under national schistosomiasis and STH control programme (NSSCP). Malaria intervention using IPTsc strategy may be integrated in NSHP with the same platform as NSSCP, however, there is limited systematic evidence to assess the operational feasibility of this approach. School aged children are a reachable target population in any endemic malaria setting. The suggested strategy will provide effective protection against malaria, hasten either the elimination process and/or diminish the reservoir and burden.
- Conditions
- Malaria,Falciparum, Anemia
- Being tested
- Dihydroartemisinin-piperaquine, Artesunate-amodiaquine
- Keywords
- Malaria, school children, randomized controlled trial, safety, effectiveness, Dihydroartemisinin-piperaquine, cognitive, Artesunate-amodiaquine, malaria serology, drug resistance
- Medical subject headings
- Malaria, Falciparum, Anemia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquineDrug
Dihydroartemisinin-piperaquine (DP). One of the Artemisinin combination therapy(ACTs), indicated for treatment of uncomplicated malaria. It will to be given every 4 months 3 rounds for a year.
Artesunate-amodiaquineDrug
Artesunate-amodiaquine (ASAQ). One of the Artemisinin combination therapy(ACTs), indicated for treatment of uncomplicated malaria. It will to be given every 4 months 3 rounds for a year.
| Study group | Role | What they receive |
|---|---|---|
| DP | Experimental | Dihydroartemisinin-piperaquine (DP), antimalarial drug to be given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. Receives: Drug: Dihydroartemisinin-piperaquine |
| ASAQ | Active comparator | Artesunate-amodiaquine (ASAQ), antimalarial drugs to be given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. Receives: Drug: Artesunate-amodiaquine |
| Control | No intervention | No intervention drugs will be given, but normal routine standard of care will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean haemoglobin concentration at months 12 and 20 of follow-up
Will measure change from baseline haemoglobin concentration at month 12 (intervention period) and at month 20 (post intervention period to assess rebound effect) [Note: a trend of change at each visit will also be assessed with respect to malaria seasonality]
Measured: at months 0, 12 and 20
Clinical malaria incidence from month 0 till months 12 and 20 of follow up
number of symptomatic malaria episodes during and after intervention period
Measured: at months 0, 12 and 20
Secondary outcomes (9)
Prevalence of asymptomatic malaria infections at month 0, 12 and 20 of follow up
to be measured from microscopic detection of malaria parasite on blood slides
Measured: from month 0 till month12 and 20
Prevalence of PCR confirmed sub-microscopic parasitaemia at months 0,12 and 20 of follow up
Polymerase chain reaction (PCR) confirmed from random subset of finger prick dry blood spots samples
Measured: at months 0, 12 and 20
Prevalence of soil transmitted helminths and schistosomiasis
A stool sample will be used to determine prevalence (defined as adult or eggs) of STH and S. mansoni infection determined by duplicate Kato-Katz thick smears technique. Urine samples will be visually examined for the presence of blood (macrohaematuria) followed by laboratory examination for schistosomiasis infection (S.haematobium)
Measured: at baseline, at month 12 and month 20.
Prevalence of schistosomiasis
Urine samples will be visually examined for the presence of blood (macrohaematuria) followed by laboratory examination for schistosomiasis infection (S.haematobium) for confirmation.
Measured: at baseline, at month 12 and month 20.
Prevalence of validated common P. falciparum polymorphisms known to be associated with drug sensitivity at baseline, at months 12 and 20
from random subset of finger prick dry blood spots samples
Measured: at baseline, at month 12 and 20.
Proportion of children seropositive for Plasmodium falciparum AMA-1 and MSP-119 at baseline, at month 12 and 20
from random subset of finger prick dry blood spots samples, Antibody responses to P. falciparum blood-stages antigens, apical membrane antigen (AMA-1) and merozoite surface protein (MSP-119) will be determined.
Measured: at baseline, at month 12 and 20.
Change in serum antibody responses to Plasmodium falciparum AMA-1 and MSP-119 at baseline, at month 12 and 20
From random subset of finger prick dry blood spots samples to be eluted for ELISA
Measured: at baseline, at month 12 and 20.
Percentages of school children with malnutrition through WHO's BMI z-score
weight in kilograms and height in meters will be combined to report BMI in kg/m^2
Measured: at month 0, 12, and 20
Relative risk (RR), for all adverse events categorised to severity at month 12 and 20
Adverse events will be detected throughout the study, Each intervention arm will be compared to control arm to determine risk of an adverse event among the two arms. Also events in two intervention arms will be compared to each other to assess risk in the two intervention arms.
Measured: at month 12 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start26 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled, open label study assessing the effectiveness and safety of 2 antimalarial drugs for IPTsc, namely DP and ASAQ by a 3-arm trial using a "balanced block design" with the "standard of care" arm as reference.
- Masking
- None (open label)
- Enrolment
- 1,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Dr. Geofrey Makenga, National Institute for Medical Research, Tanzania
- Investigators
- John PA Lusingu, MD, PhD, Principal investigator, National Institute for Medical Research, TanzaniaJean-pierre Van geertruyden, MD, PhD, Principal investigator, Global health institute, University of Antwerp, Belgium.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640403
- Sponsor's protocol ID
- TEAM VERSION3
- Acronym
- InSMART-school
- Status last verified
- Nov 2024
- First submitted
- 14 Aug 2018
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hhera JJ, Makenga G, Baraka V, Francis F, Nakato S, Gesase S, Mtove G, Madebe R, Kyaruzi E, Minja DTR, Lusingu JPA, Van Geertruyden JP. Malaria-malnutrition interaction: prevalence, risk factors, and the impact of intermittent preventive therapy for malaria on nutritional status of school-age children in Muheza, Tanga, Tanzania - A cross-sectional survey and a randomized controlled open-label trial. BMC Public Health. 2025 Aug 13;25(1):2754. doi: 10.1186/s12889-025-23315-w.
PubMed 40804388Makenga G, Baraka V, Francis F, Nakato S, Gesase S, Mtove G, Madebe R, Kyaruzi E, Minja DTR, Lusingu JPA, Geertruyden JV. Effectiveness and safety of intermittent preventive treatment with dihydroartemisinin-piperaquine or artesunate-amodiaquine for reducing malaria and related morbidities in schoolchildren in Tanzania: a randomised controlled trial. Lancet Glob Health. 2023 Aug;11(8):e1277-e1289. doi: 10.1016/S2214-109X(23)00204-8.
PubMed 37474234Makenga G, Baraka V, Francis F, Nakato S, Gesase S, Mtove G, Madebe R, Kyaruzi E, Minja DTR, Lusingu JPA, Van Geertruyden JP. Effectiveness and safety of intermittent preventive treatment for malaria using either dihydroartemisinin-piperaquine or artesunate-amodiaquine in reducing malaria related morbidities and improving cognitive ability in school-aged children in Tanzania: A study protocol for a controlled randomised trial. Contemp Clin Trials Commun. 2020 Feb 20;17:100546. doi: 10.1016/j.conctc.2020.100546. eCollection 2020 Mar.
PubMed 32382685
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Intermittent Preventive Treatment for Malaria Using Either Dihydroartemisinin-piperaquine or Artesunate-amodiaquine in Reducing Malaria Related Morbidities and Improving Cognitive Ability in School-aged Children in Tanzania: A Controlled Randomised Trial
- ClinicalTrials.gov ID
- NCT03640403
- Acronym / sponsor ID
- InSMART-school / TEAM VERSION3
- Conditions
- Malaria,Falciparum, Anemia
- Keywords
- Malaria, school children, randomized controlled trial, safety, effectiveness, Dihydroartemisinin-piperaquine, cognitive, Artesunate-amodiaquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,555 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Collaborators
- Universiteit Antwerpen
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Aug 2018 (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:
In high-transmission settings, up to 70% of school-aged children harbour malaria parasites which is mostly asymptomatic, thus, from an epidemiological point of view, they contribute significantly as reservoir to onward malaria transmission to others. In endemic areas, malaria accounts for around 50% of the mortality, 13-50% of all school absenteeism, and causes anaemia in approximately 85 million school-aged children of sub Saharan Africa that also impairs the cognitive development of children. Intermittent preventive treatment (IPT) of pregnant women as well as seasonal malaria chemoprevention in children under the age of five have been implemented in several sub-Saharan countries and have proven to be very effective. However, none of these IPT strategies is targeting school children. A clinical trial is being conducted to expand the IPT by testing effectiveness and safety of two antimalarial drugs Dihydroartemisinin-piperaquine (DP) and Artesunate-amodiaquine (ASAQ) in preventing malaria related morbidity in school aged children (IPTsc) living in high endemic areas.
Methods:
A randomized, open label, controlled trial will enrol 1602 school children aged 5-15 years, who will receive either DP or ASAQ or control (no drug ), using a "balanced block design" with the "standard of care" arm as reference. The interventional treatments are given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. All study-arms receive bed nets, early diagnosis and care for malaria, and praziquantel and albendazole as mass treatment for helminthiasis. The primary endpoint are change from baseline in mean haemoglobin concentration at months 12 and 20 of follow-up and clinical malaria incidence from month 0 till months 12 and 20 of follow up. Adverse events will be monitored throughout the study. Mixed design methods will be used to assess the acceptability, cost-effectiveness and feasibility of this IPTsc as part of a more comprehensive school children health package.
Discussion:
The national school health programme (NSHP), Tanzania, combines schistosomiasis and soil transmitted helminthes (STH) control package under national schistosomiasis and STH control programme (NSSCP). Malaria intervention using IPTsc strategy may be integrated in NSHP with the same platform as NSSCP, however, there is limited systematic evidence to assess the operational feasibility of this approach. School aged children are a reachable target population in any endemic malaria setting. The suggested strategy will provide effective protection against malaria, hasten either the elimination process and/or diminish the reservoir and burden.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized, controlled, open label study assessing the effectiveness and safety of 2 antimalarial drugs for IPTsc, namely DP and ASAQ by a 3-arm trial using a "balanced block design" with the "standard of care" arm as reference.
| Arm | Type | Receives |
|---|---|---|
| DP | Experimental | Drug: Dihydroartemisinin-piperaquineDihydroartemisinin-piperaquine (DP), antimalarial drug to be given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. |
| ASAQ | Active comparator | Drug: Artesunate-amodiaquineArtesunate-amodiaquine (ASAQ), antimalarial drugs to be given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. |
| Control | No intervention | –No intervention drugs will be given, but normal routine standard of care will be provided. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Includes parental/guardian informed consent
- Assent by primary school children aged 11 years and above.
- Aged 5-15 years.
- Currently, lives within the pre-defined catchment area of Muheza District.
- Will remain within the same area throughout the study period (preferably class five and below).
Key exclusion criteria (10 listed)
- Students at class 6 and 7
- Currently enrolled in another study or participated in another investigational drug study within the last 30 days.
- Known to have heart disease or a known cardiac ailment.
- Reports known hypersensitivity to the study drugs.
- Not willing to undergo all study procedures including physical examination and to provide blood samples as per this study 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 |
|---|---|---|
| Dihydroartemisinin-piperaquineDihydroartemisinin-piperaquine (DP). One of the Artemisinin combination therapy(ACTs), indicated for treatment of uncomplicated malaria. It will to be given every 4 months 3 rounds for a year. | Drug | DP |
| Artesunate-amodiaquineArtesunate-amodiaquine (ASAQ). One of the Artemisinin combination therapy(ACTs), indicated for treatment of uncomplicated malaria. It will to be given every 4 months 3 rounds for a year. | Drug | ASAQ |
Primary outcome
Change from baseline in mean haemoglobin concentration at months 12 and 20 of follow-up
Time frame: at months 0, 12 and 20
Will measure change from baseline haemoglobin concentration at month 12 (intervention period) and at month 20 (post intervention period to assess rebound effect) [Note: a trend of change at each visit will also be assessed with respect to malaria seasonality]
Clinical malaria incidence from month 0 till months 12 and 20 of follow up
Time frame: at months 0, 12 and 20
number of symptomatic malaria episodes during and after intervention period
9 secondary outcomes
Prevalence of asymptomatic malaria infections at month 0, 12 and 20 of follow up
Time frame: from month 0 till month12 and 20
Prevalence of PCR confirmed sub-microscopic parasitaemia at months 0,12 and 20 of follow up
Time frame: at months 0, 12 and 20
Prevalence of soil transmitted helminths and schistosomiasis
Time frame: at baseline, at month 12 and month 20.
Prevalence of schistosomiasis
Time frame: at baseline, at month 12 and month 20.
Prevalence of validated common P. falciparum polymorphisms known to be associated with drug sensitivity at baseline, at months 12 and 20
Time frame: at baseline, at month 12 and 20.
Proportion of children seropositive for Plasmodium falciparum AMA-1 and MSP-119 at baseline, at month 12 and 20
Time frame: at baseline, at month 12 and 20.
Change in serum antibody responses to Plasmodium falciparum AMA-1 and MSP-119 at baseline, at month 12 and 20
Time frame: at baseline, at month 12 and 20.
Percentages of school children with malnutrition through WHO's BMI z-score
Time frame: at month 0, 12, and 20
Relative risk (RR), for all adverse events categorised to severity at month 12 and 20
Time frame: at month 12 and 20
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 20 Nov 2024.
- Derived from this study: PubMed 40804388Hhera JJ, Makenga G, Baraka V, Francis F, Nakato S, Gesase S, Mtove G, Madebe R, Kyaruzi E, Minja DTR, Lusingu JPA, Van Geertruyden JP. Malaria-malnutrition interaction: prevalence, risk factors, and the impact of intermittent preventive therapy for malaria on nutritional status of school-age children in Muheza, Tanga, Tanzania - A cross-sectional survey and a randomized controlled open-label trial. BMC Public Health. 2025 Aug 13;25(1):2754. doi: 10.1186/s12889-025-23315-w.
- Derived from this study: PubMed 37474234Makenga G, Baraka V, Francis F, Nakato S, Gesase S, Mtove G, Madebe R, Kyaruzi E, Minja DTR, Lusingu JPA, Geertruyden JV. Effectiveness and safety of intermittent preventive treatment with dihydroartemisinin-piperaquine or artesunate-amodiaquine for reducing malaria and related morbidities in schoolchildren in Tanzania: a randomised controlled trial. Lancet Glob Health. 2023 Aug;11(8):e1277-e1289. doi: 10.1016/S2214-109X(23)00204-8.
- Derived from this study: PubMed 32382685Makenga G, Baraka V, Francis F, Nakato S, Gesase S, Mtove G, Madebe R, Kyaruzi E, Minja DTR, Lusingu JPA, Van Geertruyden JP. Effectiveness and safety of intermittent preventive treatment for malaria using either dihydroartemisinin-piperaquine or artesunate-amodiaquine in reducing malaria related morbidities and improving cognitive ability in school-aged children in Tanzania: A study protocol for a controlled randomised trial. Contemp Clin Trials Commun. 2020 Feb 20;17:100546. doi: 10.1016/j.conctc.2020.100546. eCollection 2020 Mar.
- Individual participant dataSharing planned: Undecided
Related trials for Malaria,Falciparum
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Not yet recruiting
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral
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.
John PA Lusingu, MD, PhD principal investigator
National Institute for Medical Research, Tanzania
Jean-pierre Van geertruyden, MD, PhD principal investigator
Global health institute, University of Antwerp, Belgium.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dihydroartemisinin-piperaquine and Artesunate-amodiaquine in people with Malaria,Falciparum and Anemia, run by National Institute for Medical Research, Tanzania at 1 site 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 5 inclusion and 10 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 20 Nov 2024. 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 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 phase mean?
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?
Change from baseline in mean haemoglobin concentration at months 12 and 20 of follow-up (time frame: at months 0, 12 and 20). 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 NCT03640403, which also lists 3 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 20 Nov 2024.