Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

What Was Tested

In this phase 2 trial, researchers set out to test Terlipressin.

It had 1 arm (groups): Terlipressin acetate continuous infusion (experimental).

The registry classes the interventions as drug.

More on the Plan

After establishing safety and tolerance of infusion for 7 days, patients will be transitioned to an outpatient setting where they will be treated with terlipressin continuous infusion for an additional 21 days, monitored daily by home care nurses.

A total of 6 patients will be treated.

Who Took Part

The registry lists 6 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days.

The full record lists 1 inclusion and 20 exclusion criteria; among the exclusions: ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis; blood clotting international normalized ratio (inr) \> 2.5; current or recent (within 3 months of consent) renal dialysis.

How the Study Was Run

Design: single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-07-15 with completion listed for 2019-04-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites (time frame: 28 day treatment period and 28 day post-treatment).

It also tracked 1 secondary outcome, for example Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Terlipressin in 6 people.

Its size is small, so on its own it can only give an early look.

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.