Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

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