This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1. Out of every three participants, two will receive terlipressin and one will receive placebo. Assignments will be made randomly.
The primary objective of this trial is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Terlipressin solution for injection
Matching placebo solution for injection
Percentage of Participants With Verified HRS Reversal
Defined as the percentage of participants with 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart, while on treatment by Day 14 or discharge (on treatment defined as up to 24 hours after the final dose of study drug), per protocol.
Time frame: within 15 Days
Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis
Defined as the percentage of participants with verified HRS reversal who lived at least 10 days without RRT, and were otherwise viable (per protocol) for inclusion in the primary endpoint analysis
Time frame: within 25 days
Percentage of Participants With HRS Reversal
Defined as the percentage of participants with a SCr value no more than 1.5 mg/dL by Day 14 or discharge, and were viable (per protocol) for inclusion in the secondary endpoint analysis
Time frame: within 14 days
Percentage of Participants With Durable HRS Reversal
Defined as the percentage of participants maintaining HRS reversal without RRT to Day 30
Time frame: Day 30
Percentage pf Participants in the SIRS Subgroup With HRS Reversal
Defined as the percentage of participants in the SIRS subgroup with HRS reversal by Day 14 or discharge
Time frame: within 14 days
Percentage of Participants With Verified HRS Reversal Without HRS Recurrence by Day 30
Defined as the percentage of participants who had achieved verified HRS reversal by Day 15 or discharge and did not revert to baseline measures by day 30
Time frame: Day 30
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