NCT06800248尚未招募3 期
A Phase III Single-center, Randomized, Double-Blinded, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of Emodepside Compared to Multiple Doses of Mebendazole in Adolescent and Adult Participants With Soil-transmitted Helminthiasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Cured of T. trichiura infection
研究概览
简要总结
This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff, Site staff
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
- •T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).
- •A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.
- •Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.
- •Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.
排除标准
- •Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
- •Any of the following:
- •Platelet <75,000/mm3
- •Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) >3x upper limit of normal (ULN)
- •Total bilirubin >2xULN
- •Estimated Glomerular Filtration Rate (eGFR) <90 ml/min/1.73 m2
- •Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
- •Use of sensitive CYP3A4 substrates within 14 days before the start of the first study intervention and until at least 14 days after the last administration of study intervention.
- •Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention.
- •Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
- •Known allergy/hypersensitivity to mebendazole and/or emodepside or excipients.
研究组 & 干预措施
Mebendazole
Active Comparator
干预措施: Mebendazole 100 MG (Drug)
Mebendazole
Active Comparator
干预措施: matching placebo of emodepside (Drug)
Emodepside
Experimental
干预措施: emodepside (BAY 44-4400) (Drug)
Emodepside
Experimental
干预措施: similar placebo to mebendazole (Drug)
结局指标
主要结局
Cured of T. trichiura infection
时间窗: Test of Cure Visit at 14 to 21 days after end of treatment
Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit
次要结局
- Cured of A. lumbricoides infection(Time Frame: Test of Cure Visit at 14 to 21 days after end of treatment)
- Occurrence of TEAEs(Adverse events that occur after the first dose of study intervention up to 21 days after the last dose of study intervention)
研究者
研究点 (2)
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