Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

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

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.

Inclusion Criteria:

• Liver volume ≥ 4 liter

• ≥ 20 liver cysts

• Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:

  • Abdominal distention perceived as uncomfortable
  • Frequent abdominal pain
  • Early satiety
  • Nausea (with the inclusion of dyspeptic complaints)
  • Dyspnea

• Diagnosed with ADPKD or ADPLD

• Male and female patients of 18 years and older

• Written informed consent

Exclusion Criteria:

• Creatinine clearance < 20 ml/min
• Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
• Hormonal replacement therapy
• Hormonal contraception
• Pregnant or lactating
• Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
• Planned to undergo any surgery of the liver during study participation
• Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
• Patients with known allergies to somatostatin or its analogues or any of its components
• Patients who received somatostatin analogues in the 6 months preceding study inclusion