A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Assess the Safety and Effects of Intravenous Conivaptan on the Hepatic Hemodynamic Response in Stable Euvolemic or Hypervolemic Cirrhotic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose
研究概览
简要总结
To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and appropriate privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
- •Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis
- •Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both
排除标准
- •Clinical evidence of volume depletion or dehydration
- •Subject has a history of bleeding from esophageal varices within three months before the start of the study
研究组 & 干预措施
Regimen 1 Conivaptan 12.5 mg
Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
干预措施: conivaptan (Drug)
Regimen 2 Conivaptan 25 mg
Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
干预措施: conivaptan (Drug)
Regimen 3 Placebo
Placebo continuous intravenous infusion over 6.5 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose
时间窗: Baseline and 0.5, 1, and 1.5 hours post dose
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose
时间窗: Baseline and 0.5, 1, and 1.5 hours post dose
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose
时间窗: Baseline and 0.5, 1, and 1.5 hours post dose
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose
时间窗: Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose
时间窗: Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
次要结局
- Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose(Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose)