MalariaPhase 2/3SAFEPRIM-IINCT02654730
Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia
A Phase 2/3 study testing Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient, Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient and Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males. Read more about this study
- Who is it for?
- Ages 10 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient, Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient and Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteThe Gambia
- Study dates
- Dec 2015to Dec 2016
- 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 10 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- G6PD deficiency by fluorescent Spot test (for intervention groups and control group receiving DHA-PPQ only (N=50)
- G6PD normal activity by fluorescent Spot test for control groups (N=20)
- Informed consent by participant or caregiver (an assent is required for those 12-17 years)
Who cannot join
- Enrolled in another clinical trial
- Fever: temperature >37.5°C (axillary) or history of fever in the last 24 hours
- Evidence of severe illness or active infection other than malaria
- Known allergy to study medications
- Hb <11 g/dL
- Antimalarials taken within the last 2 weeks
Show all 9Show fewer
- PQ taken within the last 4 weeks and blood transfusion within the last 90 days
- Current use of tuberculosis or anti-retroviral medication, sulphonamides, dapsone, nitrofurantoin, nalidixic acid, ciprofloxacin, methylene blue, toluidine blue, phenazopyridine and co-trimoxazole.
- History of severe chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males.
Read the detailed description
In the current study the investigators aim to assess safety of PQ, in particular the risk of acute haemolysis, when given together with dihydroartemisinin-piperaquine (DHAP) in G6PD deficient individuals. Forty male participants with haemoglobin levels (≥11g/dL), reduced G6PD enzyme function, and aged ≥10years will be sequentially enrolled into two dosing cohorts consisting of 20 individuals and doses of 0.25 and 0.4 mg/kg PQ in combination with a full three-day course of DHAP. Participants will first be assigned to the lowest open cohort; enrolment in the next cohort is initiated after tolerability and short-term safety is demonstrated at the preceding lower dose. Furthermore, the investigators will include 3 control groups into the first cohort: i) 10 male participants aged ≥10years with normal haemoglobin levels (≥11g/dL) and a reduced G6PD enzyme function will receive DHAP only, ii) 10 male participants with normal haemoglobin levels (≥11g/dL) and normal G6PD enzyme function will receive 0.25 mg/kg PQ in combination with a full three-day course of DHAP, and iii) 10 male participants with normal haemoglobin levels (≥11g/dL) and normal G6PD enzyme function will receive 0.4 mg/kg PQ with DHAP.
Enrolment and group assignment Individuals who agree to participate for screening and meet all inclusion criteria, will be invited for enrolment. During this, participants and/or their carers will be informed again about the objectives and practical consequences of participation in the current study and asked to sign an informed consent form. The possibility of withdrawal from the study, at any time and without any declaration of the reason will again be pointed out.
After enrolment, participants will be assigned to the lowest-dose open cohort, with enrolment in the second cohort initiated after tolerability and short-term safety is demonstrated at the preceding lower dose (this enrolment to the second cohort accounts for G6PD deficient participants only). Within each cohort, the first 2 participants of the intervention group are treated and monitored for 6 days for immediate side-effects and haematological abnormalities before the rest of the participants of that particular intervention group are enrolled and treated. Once safety of these first 2 participants is confirmed, the next 4 subjects are enrolled and treatment for the next 4 subjects is initiated on day 2 of the last treated participant of the preceding 4 subjects. The last two groups for each intervention group comprise 5 individuals, making a total of 20. After inclusion of the intervention group of the first cohort (n=20) is completed (follow-up day 14 of last participant in that group), a 10-day safety observation period is installed before enrolment of the intervention group of the second cohort is initiated.
Interventions and evaluation Clinical follow-up of participants and sampling will be done twice daily for the first 4 days (days 0, 1, 2 and 3) and once daily on days 4, 5, 7, 10, 14 and 28. At each time-point participants will be examined clinically (except for day 28) and a structured questionnaire is used to determine the occurrence of side effects. Furthermore, laboratory safety parameters are measured, including haematology, biochemistry, and urine dipstick for haemoglobinuria/urobilinogen. Five individuals from each intervention group (total of 10) will also be asked to provide seven venous blood samples (of less than 1 mls each) on days 0, 1 and 2 to study pharmacokinetics of PQ in G6PD deficient individuals
- Conditions
- Malaria
- Being tested
- Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient, Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient, Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient, Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD normal, Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD normal
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficientDrug
Also called Eurartesim
G6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days
Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficientDrug
G6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.25mg/kg of primaquine on the first day of DHAP treatment.
Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficientDrug
G6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.4mg/kg of primaquine on the first day of DHAP treatment.
Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD normalDrug
G6PD normal participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.25mg/kg of primaquine on the first day of DHAP treatment.
Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD normalDrug
G6PD normal participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.4mg/kg of primaquine on the first day of DHAP treatment.
| Study group | Role | What they receive |
|---|---|---|
| G6PD deficient 0.25 mg/kg PQ + DHAP | Experimental | Not described Receives: Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient |
| G6PD deficient 0.4 mg/kg PQ + DHAP | Experimental | Not described Receives: Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient |
| G6PD deficient DHAP only | Active comparator | Not described Receives: Drug: Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient |
| G6PD normal 0.25 mg/kg PQ + DHAP | Active comparator | Not described Receives: Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD normal |
| G6PD normal 0.4 mg/kg PQ + DHAP | Active comparator | Not described Receives: Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin concentration relative to baseline value as measured by HemoCue
Measured: 28 days
Secondary outcomes (9)
Haematology abnormalities during follow-up: haptoglobin concentration measured in venous blood samples by full blood count analysis
Measured: 28 days
Biochemistry abnormalities during follow-up: bilirubin concentration
Measured: 28 days
Biochemistry abnormalities during follow-up: lactate dehydrogenase
Measured: 28 days
Biochemistry abnormalities during follow-up: creatinine
Measured: 28 days
Biochemistry abnormalities during follow-up: potassium
Measured: 28 days
Number of participants with treatment-related adverse events graded and evaluated in terms of relatedness
grading and assessing relatedness will be done following according to criteria of the NIH/NIAID division of microbiology and infectious diseases (DMID)https://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Documents/dmidadulttox.pdf
Measured: 28 days
Haematology abnormalities during follow-up: mean corpuscular volume (MCV) measured in venous blood samples by full blood count analysis
Measured: 28 days
Haematology abnormalities during follow-up: red cell distribution width (RDW) measured in venous blood samples by full blood count analysis
Measured: 28 days
Haematology abnormalities during follow-up: leukocyte count measured in venous blood samples by full blood count analysis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionDec 2016 (estimated)
Why it stopped: Enrollment took longer than anticipated; it was financially and logistically impossible to recruit the final cohort (G6PDd 0.4mg/kg PQ).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654730
- Sponsor's protocol ID
- SAFEPRIM-II
- Acronym
- SAFEPRIM-II
- Status last verified
- Jan 2016
- First submitted
- 5 Jan 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: WWARN
Publications
Eziefula AC, Pett H, Grignard L, Opus S, Kiggundu M, Kamya MR, Yeung S, Staedke SG, Bousema T, Drakeley C. Glucose-6-phosphate dehydrogenase status and risk of hemolysis in Plasmodium falciparum-infected African children receiving single-dose primaquine. Antimicrob Agents Chemother. 2014 Aug;58(8):4971-3. doi: 10.1128/AAC.02889-14. Epub 2014 Jun 9.
PubMed 24913169Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018.
PubMed 29324864
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia
- ClinicalTrials.gov ID
- NCT02654730
- Acronym / sponsor ID
- SAFEPRIM-II / SAFEPRIM-II
- Conditions
- Malaria
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment took longer than anticipated; it was financially and logistically impossible to recruit the final cohort (G6PDd 0.4mg/kg PQ).
- Enrolment
- 61 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- 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.
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males.
Detailed description
In the current study the investigators aim to assess safety of PQ, in particular the risk of acute haemolysis, when given together with dihydroartemisinin-piperaquine (DHAP) in G6PD deficient individuals. Forty male participants with haemoglobin levels (≥11g/dL), reduced G6PD enzyme function, and aged ≥10years will be sequentially enrolled into two dosing cohorts consisting of 20 individuals and doses of 0.25 and 0.4 mg/kg PQ in combination with a full three-day course of DHAP. Participants will first be assigned to the lowest open cohort; enrolment in the next cohort is initiated after tolerability and short-term safety is demonstrated at the preceding lower dose. Furthermore, the investigators will include 3 control groups into the first cohort: i) 10 male participants aged ≥10years with normal haemoglobin levels (≥11g/dL) and a reduced G6PD enzyme function will receive DHAP only, ii) 10 male participants with normal haemoglobin levels (≥11g/dL) and normal G6PD enzyme function will receive 0.25 mg/kg PQ in combination with a full three-day course of DHAP, and iii) 10 male participants with normal haemoglobin levels (≥11g/dL) and normal G6PD enzyme function will receive 0.4 mg/kg PQ with DHAP.
Enrolment and group assignment Individuals who agree to participate for screening and meet all inclusion criteria, will be invited for enrolment. During this, participants and/or their carers will be informed again about the objectives and practical consequences of participation in the current study and asked to sign an informed consent form. The possibility of withdrawal from the study, at any time and without any declaration of the reason will again be pointed out.
After enrolment, participants will be assigned to the lowest-dose open cohort, with enrolment in the second cohort initiated after tolerability and short-term safety is demonstrated at the preceding lower dose (this enrolment to the second cohort accounts for G6PD deficient participants only). Within each cohort, the first 2 participants of the intervention group are treated and monitored for 6 days for immediate side-effects and haematological abnormalities before the rest of the participants of that particular intervention group are enrolled and treated. Once safety of these first 2 participants is confirmed, the next 4 subjects are enrolled and treatment for the next 4 subjects is initiated on day 2 of the last treated participant of the preceding 4 subjects. The last two groups for each intervention group comprise 5 individuals, making a total of 20. After inclusion of the intervention group of the first cohort (n=20) is completed (follow-up day 14 of last participant in that group), a 10-day safety observation period is installed before enrolment of the intervention group of the second cohort is initiated.
Interventions and evaluation Clinical follow-up of participants and sampling will be done twice daily for the first 4 days (days 0, 1, 2 and 3) and once daily on days 4, 5, 7, 10, 14 and 28. At each time-point participants will be examined clinically (except for day 28) and a structured questionnaire is used to determine the occurrence of side effects. Furthermore, laboratory safety parameters are measured, including haematology, biochemistry, and urine dipstick for haemoglobinuria/urobilinogen. Five individuals from each intervention group (total of 10) will also be asked to provide seven venous blood samples (of less than 1 mls each) on days 0, 1 and 2 to study pharmacokinetics of PQ in G6PD deficient individuals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| G6PD deficient 0.25 mg/kg PQ + DHAP | Experimental | Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient |
| G6PD deficient 0.4 mg/kg PQ + DHAP | Experimental | Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient |
| G6PD deficient DHAP only | Active comparator | Drug: Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient |
| G6PD normal 0.25 mg/kg PQ + DHAP | Active comparator | Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD normal |
| G6PD normal 0.4 mg/kg PQ + DHAP | Active comparator | Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD normal |
Who may qualify
- Ages
- 10 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- G6PD deficiency by fluorescent Spot test (for intervention groups and control group receiving DHA-PPQ only (N=50)
- G6PD normal activity by fluorescent Spot test for control groups (N=20)
- Informed consent by participant or caregiver (an assent is required for those 12-17 years)
Key exclusion criteria (9 listed)
- Enrolled in another clinical trial
- Fever: temperature >37.5°C (axillary) or history of fever in the last 24 hours
- Evidence of severe illness or active infection other than malaria
- Known allergy to study medications
- Hb <11 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 |
|---|---|---|
| Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficientAlso: EurartesimG6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days | Drug | G6PD deficient DHAP only |
| Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficientG6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.25mg/kg of primaquine on the first day of DHAP treatment. | Drug | G6PD deficient 0.25 mg/kg PQ + DHAP |
| Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficientG6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.4mg/kg of primaquine on the first day of DHAP treatment. | Drug | G6PD deficient 0.4 mg/kg PQ + DHAP |
| Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD normalG6PD normal participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.25mg/kg of primaquine on the first day of DHAP treatment. | Drug | G6PD normal 0.25 mg/kg PQ + DHAP |
| Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD normalG6PD normal participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.4mg/kg of primaquine on the first day of DHAP treatment. | Drug | G6PD normal 0.4 mg/kg PQ + DHAP |
Primary outcome
Haemoglobin concentration relative to baseline value as measured by HemoCue
Time frame: 28 days
9 secondary outcomes
Haematology abnormalities during follow-up: haptoglobin concentration measured in venous blood samples by full blood count analysis
Time frame: 28 days
Biochemistry abnormalities during follow-up: bilirubin concentration
Time frame: 28 days
Biochemistry abnormalities during follow-up: lactate dehydrogenase
Time frame: 28 days
Biochemistry abnormalities during follow-up: creatinine
Time frame: 28 days
Biochemistry abnormalities during follow-up: potassium
Time frame: 28 days
Number of participants with treatment-related adverse events graded and evaluated in terms of relatedness
Time frame: 28 days
Haematology abnormalities during follow-up: mean corpuscular volume (MCV) measured in venous blood samples by full blood count analysis
Time frame: 28 days
Haematology abnormalities during follow-up: red cell distribution width (RDW) measured in venous blood samples by full blood count analysis
Time frame: 28 days
Haematology abnormalities during follow-up: leukocyte count measured in venous blood samples by full blood count analysis
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Enrollment took longer than anticipated; it was financially and logistically impossible to recruit the final cohort (G6PDd 0.4mg/kg PQ).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Background: PubMed 24913169Eziefula AC, Pett H, Grignard L, Opus S, Kiggundu M, Kamya MR, Yeung S, Staedke SG, Bousema T, Drakeley C. Glucose-6-phosphate dehydrogenase status and risk of hemolysis in Plasmodium falciparum-infected African children receiving single-dose primaquine. Antimicrob Agents Chemother. 2014 Aug;58(8):4971-3. doi: 10.1128/AAC.02889-14. Epub 2014 Jun 9.
- Derived from this study: PubMed 29324864Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018.
- Individual participant dataSharing planned: Yes. WWARN
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient, Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient and Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2016. 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 The Gambia. 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 was stopped early (reason given: Enrollment took longer than anticipated; it was financially and logistically impossible to recruit the final cohort (G6PDd 0.4mg/kg PQ).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin concentration relative to baseline value as measured by HemoCue (time frame: 28 days). 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 NCT02654730, which also lists 2 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 9 Sep 2016.