CTRI/2020/10/028535已完成2 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 -
ovartis Healthcare Pvt Ltd0 个研究点目标入组 496 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 496
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 PK Run-in Part and Part A: male and female patients ââ?°Â¥ 12 years and with a body weight ââ?°Â¥ 35.0 kg
- •Part B: after determining the effective/tolerated doses and regimens in adolescent and adult patients, male and female patients ââ?°Â¥ 2 and < 12 years and with a body weight ââ?°Â¥ 10.0 kg will be included
- •2 Microscopic confirmation of P. falciparum by Giemsa-stained thick and thin films (refer to the laboratory manual for details)
- •3 P. falciparum parasitaemia of more than 1000 and less than 150 000 parasites/Ã?µL at the time of pre-screening (i.e., Study Visit 1)
- •4 Axillary temperature ââ?°Â¥ 37.5 Ã?ºC or oral/tympanic/rectal temperature ââ?°Â¥ 38.0Ã?ºC; or similar history of fever during the previous 24 hours (history of fever must be documented)
- •5 Negative pregnancy test for women of child bearing potential (WOCBP)
- •6 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
- •7 The patient or his/her parent/legal guardian (in case of pediatric patients) is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned
排除标准
- •1 Mixed Plasmodium infections
- •2 Signs and symptoms of severe malaria according to WHO 2015 criteria unless
- •characterized by high parasitaemia only
- •3 Patients with concurrent febrile illnesses (e.g., typhoid fever)
- •4 Active infections including tuberculosis
- •5 History of, or current alcohol misuse/abuse defined as five or more drinks on the same
- •occasion on each of 5 or more days in the past 30 days
- •6 Known relevant liver disease e.g. chronic hepatitis, cirrhosis, compensated or
- •decompensated, history of hepatitis B or C, hepatitis B or A vaccination in last 3 months,
- •known gallbladder or bile duct disease, acute or chronic pancreatitis
- •7 Any confirmed or suspected immunosuppressive or immunodeficient condition,
- •including human immunodeficiency virus (HIV) infection
- •8 Women of child bearing potential, defined as all women physiologically capable of
- •becoming pregnant, unless they are using highly effective methods of contraception
- •during dosing and for the duration of the study. Highly effective contraception methods
- •Ã¯â??· Total abstinence (when this is in line with the preferred and usual lifestyle of the
- •patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
- •methods) and withdrawal are not acceptable methods of contraception
- •Female sterilization (have had surgical bilateral oophorectomy with or without
- •hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking
- •investigational drug. In case of oophorectomy alone, only when the reproductive
- •status of the woman has been confirmed by follow up hormone level assessment
- •Male sterilization (at least 6 months prior to screening). For female patients on the
- •study, the vasectomized male partner should be the sole partner for that patient
- •9 Active duodenal ulcer, ulcerative colitis, Crohnââ?¬•s disease, chronic (i.e., > 2 weeks) use
- •of non-steroidal anti-inflammatory drugs (NSAIDs)
- •10 Clinically relevant abnormalities of electrolyte balance which require correction, e.g hypokalemia, hypocalcemia or hypomagnesemia.
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