NCT01387958终止2 期
Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Measure: Change in hepatitis C viral load as assessed by PCR
研究概览
简要总结
This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).
- •No prior therapy or inadequate response to therapy for hepatitis C.
- •Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.
排除标准
- •Use of other investigational drugs within at least 30 days of enrollment
- •Women of child-bearing potential.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
LCQ908
Experimental
干预措施: LCQ908 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Measure: Change in hepatitis C viral load as assessed by PCR
时间窗: 2 weeks
次要结局
- Measure: LCQ908 concentrations in the blood(over 21 days)
- Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.(28 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 IllnessCOVID-19NCT04427501Eli Lilly and Company3,307
已完成
1 期
Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve SubjectsChronic Hepatitis C (HCV)NCT00807001Merck Sharp & Dohme LLC41
终止
2 期
Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus InfectionRespiratory Syncytial Virus InfectionsNCT03656510Janssen Research & Development, LLC246
已完成
2 期
A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) InfectionRespiratory Syncytial Virus InfectionsNCT03258502Pfizer66
终止
2 期
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital SettingCOVID-19NCT04396106Atea Pharmaceuticals, Inc.83