EUCTR2020-003284-25-Outside-EU/EEA进行中（未招募）1 期
A Phase 2 interventional, multicenter, randomized open-label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersion Formulation in combination, given once daily for 1, 2 and 3-days to adults and children with uncomplicated Plasmodium falciparum malaria
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •PK Run-in Part and Part A: male and female patients = 12 years and with a body weight = 35.0 kg.
- •Part B: after determining the effective/tolerated doses and regimens in adolescent and adult patients, male and female patients = 2 and < 12 years and with a body weight = 10.0 kg will be included.
- •Microscopic confirmation of P. falciparum by Giemsa-stained thick and thin films (refer to the laboratory manual for details).
- •P. falciparum parasitaemia of more than 1000 and less than 150 000 parasites/µL at the time of pre-screening (i.e., StudyVisit 1).
- •Axillary temperature = 37.5 ºC or oral/tympanic/rectal temperature = 38.0C; or similar history of fever during the previous 24 hours (history of fever must be documented).
- •Written informed consent must be obtained before any assessment is performed. If the patient is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients < 18 years old, who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 366
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 146
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Mixed Plasmodium infections.
- •Signs and symptoms of severe malaria according to WHO (World Health Organization) 2015 criteria unless characterized by high parasitaemia only.
- •Patients with concurrent febrile illnesses (e.g., typhoid fever).
- •Severe vomiting, defined as more than 3 times in the 24 hours prior to inclusion in the study or severe diarrhea defined as more than 3 watery stools per day.
- •Pregnant or nursing (lactating) women.
- •Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia.
- •Anemia (Hemoglobin level < 8 g/dL).
- •Patients with prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five (5) plasma half-lives (or within 4 weeks of screening if half-life is unknown).
- •History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc (heart rate-corrected QT) interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease.
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the patient in case of participation in the study.
- •The investigator should make this determination in consideration of the patient's medical history and/or clinical or laboratory evidence of any of the following:
- •AST/ALT > 2 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
- •AST/ALT > 1.5 and = 2 x ULN and total bilirubin is > ULN
- •Total bilirubin > 2 x ULN, regardless of the level of AST/ALT.
研究者
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