PACTR202104770362022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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 525
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
- 年龄范围
- 65 Year(s) 至 150 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. Active infections including tuberculosis
- •4. Patients with concurrent febrile illnesses (e.g., typhoid fever)
- •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. Severe malnutrition (body mass index (BMI) < 16.0 for patients = 12 years, and less than 70% of median normalized WHO reference weight for children < 12 years)
- •9. 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
- •10. Pregnant or nursing (lactating) women
- •11. Sexually active patients not willing to practice effective contraception
- •12. 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: • 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 • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
- •13. Sexually active males must use a condom during intercourse while taking drug and for the duration of the study and should not father a child in this period. A condom is required to be used also by vasectomized men i
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