An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ… (NCT06666491) | Clinical Trial Compass
RecruitingPhase 3
An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
India300 participantsStarted 2024-11-13
Plain-language summary
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Who can participate
Age range2 Years – 64 Years
SexALL
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Inclusion criteria
✓. Males and females \>=2 years of age and under (\<) 65 years of age, weighing \>10 kg.
✓. The participant has a positive malarial smear for P. vivax with a parasite density of \>100/microliter and \<100,000/microliter.
✓. The participant has a screening Hb value \>8 g/dL.
✓. The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
✓. The participant has a G6PD value (measured using the SD Biosensor STANDARDTM G6PD test) 6.1 units/gram (U/g) Hb for G6PD activity (6.1 U/g Hb cut-off is applicable for both males and females).
✓. A female participant is eligible to participate if she is not pregnant or breastfeeding, and if one of the following conditions applies:
✓. A WOCBP must test negative on a highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.
✓. The participant is willing and able to comply with the procedures described in the study protocol. The participant or parent/legal guardian, as applicable, has given written informed, dated consent; and the participant has given written assent, if applicable, to participate in the study.
Exclusion criteria
✕. The participant has severe P. vivax malaria as defined by WHO criteria \[WHO, 2023\].
✕. The participant has a mixed malaria infection (identified by a malarial smear).
What they're measuring
1
Number of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit
. The participant has a condition that may affect absorption of study medication, such as severe vomiting (no food or inability to take food during the previous 8 hours).
✕. The participant has a history of porphyria, psoriasis, or epilepsy.
✕. The participant has a history of allergy, intolerance to or a known contraindication to the use of mefloquine (or other aryl amino alcohol drugs), chloroquine, tafenoquine, primaquine, any other 4- or 8-AQ or any of their respective excipients.
✕. The participant has received treatment with any investigational drug within 30 days of study entry, or within 5 half-lives, whichever is longer.
✕. The participant has previously enrolled in this study.
✕. The participant has a recent history of illicit drug abuse or heavy alcohol intake that in the opinion of the investigator could compromise full participation in the study or adherence to study procedures.