Safety and efficacy of continuous infusion terlipressin (BIV201): A phase 2 trial in patients with decompensated cirrhosis and refractory ascites

What Was Tested

Researchers studied Terlipressin in this randomized controlled trial publication.

Patients with cirrhosis and refractory ascites were randomly assigned (2:1) to receive two 28-day cycles of continuous infusion BIV201 plus standard of care (SOC) separated by a ≤56-day washout (n=10), or SOC alone (n=5).

Data analysis was limited by the small sample size and confounded by a potential interaction with gabapentinoids in the BIV201+SOC group.

Who Took Part

According to the abstract, 10 patients were involved.

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

How the Study Was Run

In design terms this was a randomized and open-label study.

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

Everyone knew when Terlipressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

What Was Measured

PubMed files the paper under topics including Ascites, Terlipressin, Liver Cirrhosis, Quality of Life, Vasoconstrictor Agents, Lypressin and Paracentesis.

The authors tagged it with the keywords decompensated cirrhosis, hyponatremia, outpatient and phase 2 clinical trial.

What This Means in Plain Language

The paper is a randomized and open-label study of Terlipressin in 10 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2025 (Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society), a journal based in United States.

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