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
Novartis Healthcare Pvt Ltd3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年7月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- The primary objective of this study is to determine the effective doses of KAF156 combined with LUM-SDF given daily over 1, 2 or 3 days for treatment of uncomplicated malaria caused by P. falciparum.
研究概览
简要总结
Purpose of the study :
This study aims to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P. falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance,and for duration shorter than 3 days of treatment and/or reduced pill burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 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 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/µL at the time of pre-screening (i.e., Study Visit 1) 4 Axillary temperature ≥ 37.5 ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; 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 include ï‚· 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, Crohn’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.
结局指标
主要结局
The primary objective of this study is to determine the effective doses of KAF156 combined with LUM-SDF given daily over 1, 2 or 3 days for treatment of uncomplicated malaria caused by P. falciparum.
时间窗: PCR-corrected adequate clinical and | parasitological response (ACPR) at Day 29 (i.e., 28 days post-dose) in Parts A | and B.
次要结局
- To evaluate the safety and tolerability of KAF156/LUM-SDF.(Standard safety/tolerability)
- To further assess the effect of treatment(with KAF156/LUM-SDF by assessing)
- To assess the key PK parameters of KAF156 and lumefantrine.(PK assessments)
研究者
研究点 (3)
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