A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin

What Was Tested

The trial (phase 3) is built around Terlipressin.

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

The registry classes the interventions as drug.

More on the Plan

Hepatorenal syndrome is a rare syndrome of marked renal dysfunction in patients with cirrhosis, decompensated liver disease, and portal hypertension.

At present, there are no approved drug therapies for HRS type 1 in the US, Australia, or Canada.

The only curative treatment for HRS type 1 and the underlying end-stage cirrhosis is liver transplantation.

However, many patients will not survive long enough to receive a liver transplant and therapy, which may provide a bridge to transplantation, is badly needed.

Who Took Part

Enrollment: 196 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 subject or legally authorized representative. At least 18 years of age. Cirrhosis and ascites.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: sepsis or systemic inflammatory response syndrome (sirs); \< 2 days anti-infective therapy for documented or suspected infection; hematuria or microhematuria (\> 50 red blood cells per high power field).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

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

As a double-blind Terlipressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-10-11 with completion listed for 2013-02.

It ran at 73 sites in United States (71) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (time frame: within 14 days).

It also tracked 4 secondary outcomes, for example Percentage of Participants With HRS Reversal, Percentage of Participants With Transplant-free Survival, Percentage of Participants With Overall Survival and Percentage of Participants With Serious Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 196 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.