A Multi-Center Randomized Placebo-Controlled Double-Blind Study To Confirm Efficacy And Safety Of Terlipressin In Subjects With Hepatorenal Syndrome Type 1
Brief description of study
The purpose of this randomized, placebo-controlled study is to confirm the efficacy and safety of terlipressin in the treatment of subjects with HRS Type 1 to provide data to support regulatory approval of the New Drug Application (NDA). Efficacy will be assessed through the primary endpoint of verified HRS reversal; other important efficacy parameters will be assessed including short-term durability of verified HRS reversal, magnitude of SCr lowering effect and effects in important subgroups (eg, systemic inflammatory response syndrome [SIRS] subgroup). Safety data will be collected and incorporated into the overall safety assessment of terlipressin. Methodological obstacles encountered in the REVERSE trial that reduced its ability to show statistical significance on the primary endpoint have been addressed in this trial design.