Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Universitaire Ziekenhuizen KU Leuven59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Liver Disease

Interventions

Lanreotide Autogel 90 mg and 120 mgDRUG

administration of lanreotide sc every 4 weeks (28 days)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Leuven, Gasthuisberg

Leuven, Provincie Vlaams-Brabant, Belgium

Outcomes

Primary Outcomes

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

Reduction of total liver volume after 6 months measured by means of CT-scan.

Time frame: 6 months

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 18 months of treatment by means of CT-scan

Time frame: 18 months

Secondary Outcomes

Measurement of total liver and kidney volumes and cyst volumes at 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

Time frame: Baseline

Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan

Time frame: 6 months

Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.

Data from ClinicalTrials.gov

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