NCT01157858

Everolimus and LongActing Octreotide Trial in Polycystic Livers

Everolimus Added to Long Acting Octreotide as a Volume Reducing Treatment of Polycystic Livers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to reduce polycystic liver volume by treating with octreotide, whether or not combined with everolimus; to assess whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide monotherapy.

Detailed description

This is a single center randomized, open-label, parallel study comparing the safety and efficacy of everolimus-octreotide LAR treatment to monotherapy octreotide LAR in adult symptomatic patients with polycystic livers because of polycystic liver disease (PCLD). We 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.

Conditions

• Polycystic Liver Disease

Interventions

Type	Name	Description
DRUG	Everolimus	2.5 mg every day orally
DRUG	Octreotide LAR	40 mg every 28 days IM

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-07-07
• Last updated: 2015-06-29

Locations

1 site across 1 country: Netherlands