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
18 Years
N/A
Both
Polycystic Liver Disease
Trial Information
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
Outcome Description:
Reduction of total liver volume after 6 months measured by means of CT-scan.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Frederik Nevens, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UZ Leuven, Gasthuisberg
Authority:
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study ID:
2010-024604-10
NCT ID:
NCT01315795
Start Date:
March 2011
Completion Date:
February 2013
Related Keywords:
- Polycystic Liver Disease
- polycystic liver disease
- Liver Diseases
- Cysts
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