CTRI/2024/07/071492招募中3 期
A randomized, open-label, multi-center, interventional Phase 3 study of the efficacy and safety of tafenoquine compared to primaquine (both co-administered with chloroquine) for the radical cure (relapse prevention) of Plasmodium vivax (P. vivax) malaria in Indian participants (pediatric and adult population)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- To compare the clinical efficacy of TQ and PQ, both co-administered with CQ, for the radical cure of P. vivax malaria in Indian participants with P.vivax malaria aged greater than or equal to 2 years and weighing greater than 10 kg, during 6 months post-treatment (prevention of P. vivax recurrence)
研究概览
简要总结
| The purpose of the study is to compare the efficacy and safety of tafenoquine and primaquine when either are taken together with chloroquine for the treatment of P. vivax malaria in Indian participants aged 2 years and older. The total duration for each patient is 180 days. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females greater than or equal to 2 years of age and less than 65 years of age, weighing more than 10 kg.
- •The participant has a positive malarial smear for P. vivax with a parasite density of greater than 100 per microliter and less than 100,000 per microliter
- •The participant has a screening Hb value greater than 8 g per dL.
- •The participant has an axillary temperature greater than or equal to 37.5ï€ deg C or history of fever 48 hours before recruitment.
- •The participant has a G6PD value (measured using the SD Biosensor STANDARD G6PD test) greater than 6.1 U per g Hb for G6PD activity.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and if one of the following conditions applies:.
- •Is a woman of non-childbearing potential (WONCBP) as defined in Section Or.
- •Is a Women of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective with low user dependency during the study intervention period and for at least 90 days after the last dose of study intervention..
- •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.
排除标准
- •The participant has severe P.
- •vivax malaria as defined by WHO criteria 2023
- •The participant has a mixed malaria infection (identified by a malarial smear).
- •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.
- •The participant has a clinically significant concurrent illness (e.g., pneumonia, tuberculosis, meningitis, septicemia, dengue, coagulopathy, severe hemorrhage, or febrile convulsions prior to consent) or a pre-existing condition (e.g., renal disease, malignancy, or severe malnutrition according to WHO child growth standards) or systemic disease predisposing patients to suffer from granulocytopenia, such as rheumatoid arthritis and lupus erythematosus or severe ocular disease.
- •The participant is known to be HIV-infected and or is currently on antiretroviral therapy.
- •The participant is regularly using drugs with hemolytic potential.
- •The participant has a QT corrected by Fridericia’s formula (QTcF) greater than 450 msec evidence of bradycardia (less than 50 beats per min) or ventricular arrhythmias on the screening ECG, a history of cardiac disease (e.g., myocardial infarction, congenital heart disease, or arrhythmia), hypokalemia (less than 2.9 mmol per L) or hyperkalemia (greater than or equal to 6.0 mmol per L) at Screening.
- •The participant has taken drugs with antimalarial activity (e.g., artemisinin-based combination therapies, mefloquine, primaquine, chloroquine, tafenoquine or any other 4-AQ) within 30 days prior to study entry
- •The participant has taken or will likely require during the study the use of: a.
- •Histamine-2 blockers (restricted to first 3 days whilst receiving CQ) b.
- •Antacids (restricted to first 3 days whilst receiving CQ) c.
- •Anti-arrhythmic agents (i.e., dofetilide, procainamide, pilsicainide) e.
- •Medications that prolong the QTc interval
- •The participant has liver transaminases (ALT, AST) greater than 2 times the upper limit of normal (ULN).
结局指标
主要结局
To compare the clinical efficacy of TQ and PQ, both co-administered with CQ, for the radical cure of P. vivax malaria in Indian participants with P.vivax malaria aged greater than or equal to 2 years and weighing greater than 10 kg, during 6 months post-treatment (prevention of P. vivax recurrence)
时间窗: Participants who remain recurrence-free during the 6 months post-treatment (in the absence of concomitant/rescue medication with activity against P. vivax malaria); defined as clearance of blood-stage parasitemia confirmed by 2 consecutive negative blood smears between Day 2 and Day 8, no positive blood smear for P. vivax parasites at any point during the 6-month follow up period, and a negative P. vivax smear at the 6-month assessment.
次要结局
- To assess the occurrence of clinically relevant hemolysis with TQ and PQ co-administered with CQ for the radical cure of P. vivax malaria in Indian participants with P. vivax malaria aged greater than or equal to 2 years and weighing greater than 10 kg(Participants with clinically relevant hemolysis within the first 14 days after first dose of TQ or PQ defined as a decrease in hemoglobin of greater than or equal to 30 percent or greater than 3g per dL from baseline or an overall drop in hemoglobin below 6.0 g per dL or complications thereof (eg, required transfusions, acute renal failure))
- To evaluate the time to recurrence of P. vivax malaria for TQ and PQ co-administered with CQ in Indian participants with P. vivax malaria aged greater than or equal to 2 years and weighing greater than 10 kg(Time to recurrence of P. vivax malaria, with recurrence defined as a positive blood smear for P. vivax parasites within the 6-month follow-up period, after initial clearance of blood-stage parasitemia (2 consecutive negative blood smears between Day 2 and Day 8).)
- To evaluate the safety of TQ and PQ co-administered with CQ for the radical cure of P. vivax malaria in Indian participants with P.vivax malaria aged greater than or equal to 2 years and weighing greater than 10 kg.(Incidence of the following safety parameters during the 6 month follow-up period, AEs, TEAEs, SAEs, changes in vital signs and lab parameters.)
研究者
Dr Anup Pingle
GlaxoSmithKline Pharmaceuticals Limited
研究点 (5)
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