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

Interventional


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.

Condition

Polycystic Liver Disease

Intervention

Lanreotide Autogel 90 mg and 120 mg

Study Arms / Comparison Groups

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

Publications

* 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

Drug

Estimated Enrollment

59

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
             components

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Frederik Nevens, MD, PhD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01315795

Organization ID

2010-024604-10


Responsible Party

Principal Investigator

Study Sponsor

Universitaire Ziekenhuizen Leuven

Collaborators

 Ipsen

Study Sponsor

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


Verification Date

July 2014