Noradrenalin vs Terlipressin in Hepatorenal Syndrome

What Was Tested

The trial (phase 3) is built around Terlipressin.

It had two arms (groups): 2 (active comparator) and 1 (experimental).

Terlipressin.

Noradrenalin.

The registry classes the interventions as drug.

More on the Plan

Hepatorenal syndrome (HRS) is a major complication of cirrhosis; it is characterized by functional renal failure and poor prognosis.

The clinical signs of HRS vary depending on the clinical pattern.

HRS type 1 is characterized by a rapidly progressive renal failure; HRS type 2 by a moderate and more stable renal failure.

HRS type 1 has a very poor short term prognosis, with a median survival of only about 2 weeks; patients with HRS type 2 have a median survival of about 6 months.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age: 18-75 years. Informed written consent.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: multinodular hepatocellular carcinoma (more than 3 nodules); portal vein thrombosis; ongoing 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.

Being open-label, the Terlipressin study did not mask who received what.

It started in 2006-09 with completion listed for 2007-09.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Renal function at the beginning and at the end of therapy (time frame: two weeks).

It also tracked 1 secondary outcome, for example Circulatory function.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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