Lanreotide as Treatment of Polycystic Livers

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Lanreotide.

A minimum of 38 patients will be recruited and randomized (1:1) to receive either verum or placebo.

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

Placebo.

Lanreotide.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 38 planned participants were the target.

It was open to people of any sex aged from 18 years up to 88 years.

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

Examples of who could join: 18 yrs-of age. Multiple cysts \> 20. Is willing and able to comply with the study drug regimen and all other study requirements. Willingness to give written informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: use of oral anticonceptives or estrogen suppletion; females who are pregnant or breast-feeding; history of severe cardiac disease.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Lanreotide 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 Lanreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-10.

It ran at 2 sites in Belgium (1) and Netherlands (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Change of kidney volume and individual cyst volume on CT scan and Symptom evaluation by (validated) questionnaires.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Lanreotide in 38 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 Lanreotide compound page, all human trials.