A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

What Was Tested

The trial (phase 1, phase 2) is built around Terlipressin.

It had 1 arm (groups): Terlipressin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to people of any sex aged from 20 years up to 79 years.

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

Examples of who could join: Chronic or acute liver disease with advanced hepatic failure and portal hypertension. Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug. Age; 20 to 79 years.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: child-pugh score ≥14; fulminant hepatitis; septic shock.

How the Study Was Run

It was run as a single-group and open-label study.

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

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

It started in 2007-11 with completion listed for 2009-03.

It ran at 2 sites in Japan (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in SCr value from baseline to end of treatment (time frame: 16 days).

It also tracked 10 secondary outcomes, for example Incidence of adverse events and its severity, Laboratory test values, Vital signs, ECG, 24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions and Overall survival.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Terlipressin in 8 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.