A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 3
- 主要终点
- Rate of cardiac impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired cardiac function and require referral to a cardiologist
研究概览
简要总结
The purpose of this study is to determine the rate of kidney or heart impairment, if any, in subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and:
- •Received at least 1 dose of INX-08189 or
- •Received placebo in studies for HCV-infected subjects (INH-189-002 or INH-189-006)
- •Age 18 or older
排除标准
- 未提供
研究组 & 干预措施
Subjects treated with BMS-986094/INX-08189
Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered
干预措施: BMS-986094/INX-08189 (Drug)
Subjects treated with Placebo matching BMS-986094/INX-08189
Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered
干预措施: Placebo matching BMS-986094/INX-08189 (Drug)
结局指标
主要结局
Rate of cardiac impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired cardiac function and require referral to a cardiologist
时间窗: Up to Day 90
Rate of renal impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired renal function and require referral to a nephrologist
时间窗: Up to Day 90
次要结局
- Changes in the electrocardiographic parameters observed in association with prior exposure to single and multiple oral doses of BMS-986094 compared to pre-exposure electrocardiograms (ECGs)(Baseline (pre-dose Day 1 ECG from parent study) and By Day 30)
- Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094(By Day 30)
- Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094(By Day 30)
- Abnormalities in cardiac ejection fraction (EF) as determined by trans-thoracic echocardiogram that may be associated with prior exposure to single or multiple oral doses of BMS-986094(By Day 90)
- Changes in serum creatinine levels compared to pre-exposure levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094(Baseline (Day 1 from parent study) and By Day 14)
- Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094(By Day 7)
- Presence of signs, symptoms or medical history suggestive of heart failure or renal failure that may have been observed since last exposure to BMS-986094(By Day 90)
- Abnormalities in creatine phosphokinase (CPK) and creatine phosphokinase-metabolic (CPK-MB) levels that may be associated with prior exposure to single or multiple doses of BMS-986094(By Day 30)