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Everolimus and LongActing Octreotide Trial in Polycystic Livers — ELATE  

Polycystic Liver Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01157858
Study type Interventional
Source Radboud University
Contact
Status Completed
Phase Phase 2
Start date June 2010
Completion date July 2012
View Details
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