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Everolimus and LongActing Octreotide Trial in Polycystic Livers

2014-07-23 21:08:32 | BioPortfolio

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.

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

Conditions

Polycystic Liver Disease

Intervention

Everolimus, Octreotide LAR

Location

Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
Nijmegen
Netherlands
6500 HB

Status

Recruiting

Source

Radboud University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:32-0400

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