Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1

What Was Tested

In this phase 3 trial, researchers set out to test Terlipressin.

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.

It had two arms (groups): Terlipressin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

300 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent by participant or legally authorized representative. Cirrhosis and ascites. Discontinues midodrine and octreotide before randomization if applicable.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: at least 1 event of large volume paracentesis (lvp) at least 4 l within 2 days of randomization; sepsis and/or uncontrolled bacterial infection; less than 2 days anti-infective therapy for documented or suspected infection.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.

Those kept unaware of assignments: participant and investigator.

It started in 2016-07-13 with completion listed for 2019-07-24.

It ran at 64 sites in United States (59) and Canada (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Verified HRS Reversal (time frame: within 15 Days). Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis (time frame: within 25 days).

It also tracked 4 secondary outcomes, for example Percentage of Participants With HRS Reversal, Percentage of Participants With Durable HRS Reversal, Percentage pf Participants in the SIRS Subgroup With HRS Reversal and Percentage of Participants With Verified HRS Reversal Without HRS Recurrence by Day 30.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 300 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Terlipressin compound page, all human trials.