CTRI/2024/11/077429已完成2 期
A phase II, multicenter, randomized, assessor-blind, active comparator study to determine the efficacy, safety, and tolerability of orally administered ZY-19489 in patients with uncomplicated Plasmodium vivax malaria
Zydus Lifesciences Ltd21 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2025年2月13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
- 129
- 试验地点
- 21
- 主要终点
- To evaluate the efficacy of ZY-19489 as measured by ACPR on Day 28 in Indian symptomatic adults with uncomplicated malaria due to P.vivax monoinfection
研究概览
简要总结
Malaria is the second most common infectious disease globally. Although therapies are available for treating uncomplicated malaria, rising cases of drug resistance pose a big threat to the aim of completely eradicating the parasite. ZY-19489 is a new antimalaria drug developed by Zydus Lifesciences Ltd and is studied both in preclin-ical and clinical settings. Clinical studies have been con-ducted in patients with uncomplicated P. falciparum malaria, and these studies have suggested that ZY-19489 is efficacious as well as safe. Although in vitro evidence suggests that ZY-19489 has activity against blood stages of P. vivax, no clinical evidence is available for the activity of ZY-19489 against P. vivax malaria. Hence, this study aims to examine the efficacy, safety, and tolerability of orally administered ZY-19489 in pa-tients with uncomplicated P. vivax malaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ability to swallow oral medication.
- •2.Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and that all ques-tions by the participant have been sufficiently answered.
- •For illiterate participants, an impartial witness may sign and date the informed consent document.
- •Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •4.Microscopic confirmation of P.
- •vivax (thin and thick blood smear counts of greater than 250 para-sites/microliter)
- •Axillary temperature greater than equal to 37.5°C or history of fever within 24 h of screening 6.Age greater than 18 years and body weight greater than 45 kg 7.Hemoglobin greater than equal to 9 g/dL.
排除标准
- •1.Mixed Plasmodium infection.
- •Signs and symptoms of severe malaria (WHO 2015 criteria see reference list.
- •History of having received any antimalarial treatment (alone or in combination) during the following periods before screening: -Piperaquine, mefloquine, naphthoquine, or sulfadoxine-pyrimethamine within 6 weeks prior to screening -Amodiaquine and chloroquine within 4 weeks prior to screening -Any artemisinin derivative (artesunate, artemether, or dihydroartemisinin), quinine, lumefantrine, or any other antimalarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within 14 days prior to screening.
- •4.Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstances within 3 months of dosing.
- •5.Known allergy to the study drugs (pyronaridine derivatives/artemisinin derivatives/lumefantrine/chloroquine) and its excipients.
- •6.Patients who have recently received quinacrine or concurrently receiving other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow.
- •7.Pregnant or nursing (lactating) women.
- •8.Sexually active participants not willing to take effective contraception measures; for female participants, oral or injectable contraceptive pills, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, or vasectomized partner.
- •9.All male participants not intend to use either true abstinence, barrier method, or other effective means of contraception.
- •10.Participation in other clinical studies within 90 days before first IMP administration and/or during study participation.
- •11.Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •Examples would include but not limited to: -Known Tuberculosis -Concurrent febrile illness, e.g., Typhoid fever or known or suspected COVID-19 infection -Immunological disorders (including known or suspected seropositive HIV antibody) -Severe psychiatric disorders (active depression, recent history of depression, generalised anxiety, psychosis, schizophrenia, or other major psychiatric disorders) and major medical disorders related to cardiovascular, respiratory (including active tuberculosis), renal, gastrointestinal, endocrine, infectious, malignancy, neurological (including auditory) and history of convulsions or other abnormality -Clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e., decompensated cirrhosis, Child-Pugh stage 3 or 4), history of hepatitis B or C, hepatitis B or A vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis -History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia, or severe heart disease.
- •Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of the study -History of significant renal disorder, such as acute or chronic renal failure -Any predisposing cardiac conditions for arrhythmia, such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
- •Systemic disease manifested by tendency to granulocytopenia, such as rheumatoid arthritis and lupus erythematosus.
- •12.Participants considered at particular risk of receiving an anti-malarial or of participating in the study by the investigator.
- •13.Inability to comprehend and/or unwillingness to follow the study protocol.
- •14.Clinical or laboratory evidence of any of the following: -AST/ALT greater than 3X ULN, regardless of the level of total bilirubin -Total bilirubin greater than 2X ULN -Leukocyte count greater than15,000/μL -QTcF greater than 450 msec.
结局指标
主要结局
To evaluate the efficacy of ZY-19489 as measured by ACPR on Day 28 in Indian symptomatic adults with uncomplicated malaria due to P.vivax monoinfection
时间窗: Day 28
次要结局
- To evaluate the efficacy of ZY-19489 as measured by crude ACPR on Day 14 in Indian symptomatic adults with P.vivax uncomplicated malaria.(Day 14)
- To evaluate the safety and tolerability of ZY-19489 in Indian adults with uncomplicated P.vivax malaria.(Baseline to End of study)
- To evaluate fever clearance(Baseline to End of study)
研究者
Dr Kevinkumar Kansagra
Zydus Lifesciences Ltd
研究点 (21)
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