Everolimus and LongActing Octreotide Trial in Polycystic Livers

What Was Tested

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

It had two arms (groups): Everolimus + octreotide LAR (active comparator) and Octreotide LAR (active comparator).

Octreotide LAR combined with everolimus.

Octreotide LAR monotherapy.

The registry classes the interventions as drug.

More on the Plan

The researchers aim to include 44 patients affected by a polycystic liver either due to PCLD, 22 patients in the combination group and 22 patients in the mono therapy group.The duration of the trial will be 52 weeks.

The treatment will be 48 weeks and the last control visit will take place four weeks after the treatment.

Who Took Part

The registry lists 44 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: 18 \< age ≤ 70 years. Polycystic liver disease (PCLD), defined as ≥ 20 liver cysts. Symptomatic defined as ECOG-PS ≥ 1 (see fig 3.1)38, and having at least three out of ten PCLD symptoms:. Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.

The full record lists 15 inclusion and 23 exclusion criteria; among the exclusions: ADPKD patients; use of oral anticonceptives or estrogen supplementation; intervention (aspiration or surgical intervention) within three months before baseline.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Octreotide 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.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2010-06 with completion listed for 2012-07.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Liver volume (time frame: at baseline and at 12 months).

It also tracked 4 secondary outcomes, for example Symptoms, Quality of Life, Responders and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 44 people.

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

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