Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Brief Title

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Official Title

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

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.

Study Phase

Phase 2/Phase 3

Study Type


Primary Outcome

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

Secondary Outcome

 Measurement of total liver and kidney volumes and cyst volumes at baseline.


Polycystic Liver Disease


Lanreotide Autogel 90 mg and 120 mg

Study Arms / Comparison Groups

 Symptomatic polycystic liver disease (PCLD) patients
Description:  Symptomatic polycystic liver disease (PCLD) patients


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

March 2011

Completion Date

July 2014

Primary Completion Date

July 2014

Eligibility 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

          -  Patients who received somatostatin analogues in the 6 months preceding study inclusion




18 Years - N/A

Accepts Healthy Volunteers



Frederik Nevens, MD, PhD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Universitaire Ziekenhuizen Leuven



Study Sponsor

Frederik Nevens, MD, PhD, Principal Investigator, UZ Leuven, Gasthuisberg

Verification Date

July 2014