Lanreotide as Treatment of Polycystic Livers

Brief Title

Lanreotide as Treatment of Polycystic Livers

Official Title

Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers

Brief Summary

      To assess the efficacy of lanreotide in controling total liver volume in patients with
      polycystic livers this study will be performed. A minimum of 38 patients will be recruited
      and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other
      disease states and found to be safe and non-toxic.
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Reduction of total liver volume as determined by CT scan

Secondary Outcome

 Reduction of liver volume and individual cyst volume on CT scan.

Condition

Polycystic Liver Disease

Intervention

Placebo

Study Arms / Comparison Groups

 2
Description:  Placebo

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

38

Start Date

October 2007



Eligibility Criteria

        Inclusion Criteria:

          -  18 yrs-of age

          -  Multiple cysts > 20

          -  Cooperating patient

          -  Is willing and able to comply with the study drug regimen and all other study
             requirements

          -  Willingness to give written informed consent

        Exclusion Criteria:

          -  Use of oral anticonceptives or estrogen suppletion

          -  Females who are pregnant or breast-feeding

          -  History or other evidence of chronic pulmonary disease associated with functional
             limitation

          -  History of severe cardiac disease

          -  History or other evidence of severe illness or any other conditions which would make
             the patient, in the opinion of the investigator, unsuitable for the study

          -  Symptomatic gallstones

          -  Renal failure requiring hemodialysis
      

Gender

All

Ages

18 Years - 88 Years

Accepts Healthy Volunteers

No

Contacts

Joost PH Drenth, MD, PhD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT00565097

Organization ID

CMO 2007/010;ABR NL16194.091.0



Study Sponsor

Radboud University Medical Center

Collaborators

 Ipsen

Study Sponsor

Joost PH Drenth, MD, PhD, Principal Investigator, Radboud University Medical Center Nijmegen


Verification Date

February 2009