NCT05593666进行中（未招募）2 期
A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis
Drugs for Neglected Diseases1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年12月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Proportion of patients with initial cure at Day 28 for LXE408
研究概览
简要总结
This is a phase II, multicentre, randomized, two-arm blinded study with an open label calibrator arm in adults and adolescents (≥12 years) with confirmed primary VL.
详细描述
This study is run by DNDi with Novartis as co-development partner
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥ 18 years (at the time of the screening visit) who are able to comply with the study protocol. Following a favourable interim analysis result, patients ≥12 <18 years will also be enrolled in the trial
- •Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parent(s) or legal guardian for patients under 18 years of age. In the case of minors, assent from the child also needs to be obtained
- •Primary symptomatic VL (defined as typical parameters including, but not limited to, fever for > 2 weeks, weight loss, and splenomegaly)
- •Visualization of Leishmania amastigotes by microscopy in tissue samples (spleen or bone marrow)
排除标准
- •Clinical signs of severe VL (jaundice, spontaneous bleeding, edema, ascites, coma, organ failure)
- •Laboratory abnormalities including ALT/SGPT > 3 times ULN, total bilirubin > 1.5 times ULN, creatinine >1.5 times ULN, amylase or lipase > 1.5 times ULN, haemoglobin < 6 g/dL or other clinically significant abnormal laboratory parameters which, in the opinion of the investigator, may indicate severe VL
- •Patients with history of previous leishmaniasis and confirmed relapse
- •Patients with para-kala-azar dermal leishmaniasis
- •Patients with severe malnutrition (for children ≥12-<18 years: BMI-for-age WHO reference curves by sex, z score < -3; for adults ≥18 years: BMI < 16)
- •History of congenital or acquired immunodeficiency, including positive HIV (test at screening)
- •Known hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome®
- •Concomitant infections such as tuberculosis, severe malaria, or any other serious underlying disease that may interfere with the disease assessment (e.g., cardiac, renal, hepatic, haematologic, and pancreatic)
- •Infection with hepatitis B (HBV) or hepatitis C virus (HCV). A positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a subject. Patients with a positive HCV antibody test should have HCV RNA levels measured. Patients with positive (detectable) HCV RNA should be excluded.
- •Pregnant or nursing (lactating) women
- •Women of childbearing potential who do not accept to have a pregnancy test done at screening and/or who do not agree to use highly effective contraception while taking the investigational drug and for 5 half-lives or 5 days, whichever is longer, after stopping the investigational drug.
- •Sexually active males unwilling to use a condom during intercourse while taking the investigational drug and for 5 half-lives or 5 days, whichever is longer, after stopping the investigational drug.
研究组 & 干预措施
LXE408 short regimen
Experimental
LXE408 once daily for seven days (followed by 7 days of placebo).
干预措施: LXE408 (Drug)
LXE408 short regimen
Experimental
LXE408 once daily for seven days (followed by 7 days of placebo).
干预措施: Placebo (Other)
LXE408 long regimen
Experimental
LXE408 once daily for 14 days
干预措施: LXE408 (Drug)
Standard of care
Active Comparator
AmBisome® 10 mg/kg IV single dose (SDA)
干预措施: AmBisome® (Drug)
结局指标
主要结局
Proportion of patients with initial cure at Day 28 for LXE408
时间窗: Day 28
Initial cure defined as clinical improvement of Visceral leishmaniasis (VL), absence of parasites in the spleen or bone marrow (microscopy), and no rescue therapy on or before Day 28.
次要结局
- AUCtau for LXE408(Days 1 and 7)
- Cmax for LXE408(Days 1 and 7)
- CLss/F for LXE408(Days 1 and 7)
- Proportion of patients with initial cure at Day 28 for AmBisome®(Day 28)
- Proportion of patients with definitive cure at Day 180 for LXE408 and AmBisome®(Day 180)
- Mortality(Days 28 and 180)
- Cmax for Amphotericin B(Days 1 and 7)
- AUC0-24h for Amphotericin B(Day 1)
- Tissue parasite loads(Baseline and Day 28)
- Tmax for LXE408(Days 1 and 7)
- AUC0-infinity for Amphotericin B(Day 1)
- Blood parasite clearance(Baseline and Days 1, 3, 5, 7, 10, 14, 28 and 56)
- Proportion of patients with a positive loop-mediated isothermal amplification (LAMP) from tissue samples(Baseline and Day 28)
- Proportion of patients with a positive loop-mediated isothermal amplification (LAMP) from blood samples(Baseline and Days 28 and 56)
研究者
研究点 (1)
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