Clinical Trial: Everolimus and LongActing Octreotide Trial in Polycystic Livers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Radboud University

Current Primary Outcome: Liver volume [ Time Frame: at baseline and at 12 months ]

change of total liver volume in terms of percentage from baseline to 12 months as determined by CT


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Symptoms [ Time Frame: baseline and 12 months ]
    Change in symptoms, measured by GI-questionnaire
  • Quality of Life [ Time Frame: baseline and 12 months ]
    Change in quality of life, measured by EuroQoL-questionnaire
  • Responders [ Time Frame: baseline and 12 months ]
    Proportion of patients having any reduction in total liver volume after 12 months
  • Adverse events [ Time Frame: During 12 months of treatment ]
    Adverse events that occur in these 12 months


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: July 6, 2010
Date Started: June 2010
Date Completion:
Last Updated: June 26, 2015
Last Verified: June 2015