Clinical Trial: Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

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

Official Title: An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 90mg Every 4 Weeks in the Treatment of Symptomatic Polycystic Liver Disease

Brief Summary: An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.

Detailed Summary:
Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome:

• Reduction of total liver volume after 6 months of treatment measured by means of CT-scan. [ Time Frame: 6 months ]
  Reduction of total liver volume after 6 months measured by means of CT-scan.
• Reduction of total liver volume after 12 months of treatment by means of CT-scan [ Time Frame: 12 months ]
  Reduction of total liver volume after 12 months of treatment by means of CT-scan
• Reduction of total liver volume after 18 months of treatment by means of CT-scan [ Time Frame: 18 months ]
  Reduction of total liver volume after 18 months of treatment by means of CT-scan

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Measurement of total liver and kidney volumes and cyst volumes at baseline. [ Time Frame: Baseline ]

  Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.

  % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months

• Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan [ Time Frame: 6 months ]

  Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.

  % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months

• Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan. [ Time Frame: 12 months ]

  Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.

  % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months

• Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan [ Time Frame: 18 months ]

  Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.

  % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months

• Assessment of quality of life at baseline [ Time Frame: baseline ]
  Assessment of quality of life at baseline
• Assessment of quality of life after 6 months of treatment [ Time Frame: 6 months ]
  Assessment of quality of life after 6 months of treatment
• Assessment of quality of life after 12 months of treatment [ Time Frame: 12 months ]
  Assessment of quality of life after 12 months of treatment
• Assessment of quality of life after 18 months of treatment [ Time Frame: 18 months ]
  Assessment of quality of life after 18 months of treatment

Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: January 11, 2011
Date Started: March 2011
Date Completion:
Last Updated: July 7, 2014
Last Verified: July 2014