Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

What Was Tested

The trial (phase 2) is built around Terlipressin.

Patients with advanced cirrhosis of the liver develop kidney problems occasionally.

It had three arms (groups): one (experimental), one (experimental) and Terlipressin (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 54 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Written Informed consent prior to any study-related procedures. Age ≥ 18 years and ≤ 70 years. Cirrhosis of the liver by laboratory examination, clinical history or biopsy. History of ascites.

The full record lists 7 inclusion and 27 exclusion criteria; among the exclusions: mean arterial pressure (map) \< 60 mmhg; large volume paracentesis (lvp) in the 3 days prior to screening; sepsis, uncontrolled bacterial infection or less than 2 days anti-infective therapy for documented or suspected bacterial infection.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Terlipressin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Terlipressin study: the participants and staff both knew the treatment.

It started in 2024-04-17 with completion listed for 2026-05.

It ran at 6 sites in India (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in estimated GFR (eGFR) from baseline (time frame: 4 days).

It also tracked 3 secondary outcomes, for example Proportion of patients achieving Hepatorenal Syndrome reversal, Proportion of subjects experiencing Hepatorenal Syndrome recurrence and Overall survival.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Terlipressin in 54 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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