Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Phase 2

Completed

• Conditions: Polycystic Liver Disease
• Interventions: Drug: Lanreotide Autogel 90 mg and 120 mg

• Registration Number: NCT01315795
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-01-11
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symptomatic polycystic liver disease (PCLD) patients	Lanreotide Autogel 90 mg and 120 mg	Symptomatic polycystic liver disease (PCLD) patients

Primary Outcome Measures

Name	Time	Method
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.	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	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	18 months	Reduction of total liver volume after 18 months of treatment by means of CT-scan

Secondary Outcome Measures

Name	Time	Method
Assessment of quality of life at baseline	baseline	Assessment of quality of life at baseline
Assessment of quality of life after 12 months of treatment	12 months	Assessment of quality of life after 12 months of treatment
Assessment of quality of life after 18 months of treatment	18 months	Assessment of quality of life after 18 months of treatment
Measurement of total liver and kidney volumes and cyst volumes at baseline.	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 volume and cyst volume after 12 months of treatment by means of CT scan.	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	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 after 6 months of treatment	6 months	Assessment of quality of life after 6 months of treatment
Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan	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

Trial Locations

Locations (1)

UZ Leuven, Gasthuisberg; 🇧🇪 Leuven, Provincie Vlaams-Brabant, Belgium