Conditions: Hepatorenal Syndrome
Keywords: Hepatorenal Syndrome HRS ifetroban
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: no

Brief summary:
A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.

Detailed description:

Arms:
arm 1: 60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 2: 60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 1 HRS. arm 3: 60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 4: 60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 5: 60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. arm 6: 60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. arm 7: 60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. arm 8: 60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. arm 9: 60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS.

Interventions: intervention 1: Ifetroban Injection intervention 2: Placebo
Intervention descriptions: intervention 1: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose intervention 2: Sterile water with 5% Dextrose

Protocol document: