Lanreotide as Treatment of Polycystic Livers (LOCKCYST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565097
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : February 17, 2009
Information provided by:
Radboud University

November 28, 2007
November 29, 2007
February 17, 2009
October 2007
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Reduction of total liver volume as determined by CT scan [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00565097 on Archive Site
  • Reduction of liver volume and individual cyst volume on CT scan. [ Time Frame: 6 months ]
  • Change of kidney volume and individual cyst volume on CT scan [ Time Frame: 6 months ]
  • Symptom evaluation by (validated) questionnaires [ Time Frame: 6 months ]
Same as current
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Lanreotide as Treatment of Polycystic Livers
Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
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.
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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Polycystic Liver Disease
  • Hepatomegaly
  • Liver Diseases
  • Polycystic Kidney, Autosomal Dominant
  • Drug: Placebo
  • Drug: Lanreotide
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 1
    Intervention: Drug: Lanreotide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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
Sexes Eligible for Study: All
18 Years to 88 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
CMO 2007/010;ABR NL16194.091.0
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Radboud University
Principal Investigator: Joost PH Drenth, MD, PhD Radboud University Medical Center Nijmegen
Principal Investigator: Loes van Keimpema, MSc Radboud University Medical Center Nijmegen
Principal Investigator: Frederik Nevens, MD, PhD University Hospital Gasthuisberg, University of Leuven
Radboud University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP