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Lanreotide as Treatment of Polycystic Livers (LOCKCYST)

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ClinicalTrials.gov Identifier: NCT00565097
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : February 17, 2009
Sponsor:
Collaborator:
Ipsen
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE November 28, 2007
First Posted Date  ICMJE November 29, 2007
Last Update Posted Date February 17, 2009
Study Start Date  ICMJE October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
Reduction of total liver volume as determined by CT scan [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00565097 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lanreotide as Treatment of Polycystic Livers
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Liver Disease
  • Hepatomegaly
  • Liver Diseases
  • Polycystic Kidney, Autosomal Dominant
Intervention  ICMJE
  • Drug: Placebo
  • Drug: Lanreotide
Study Arms  ICMJE
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 1
    Lanreotide
    Intervention: Drug: Lanreotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 28, 2007)
38
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00565097
Other Study ID Numbers  ICMJE CMO 2007/010;ABR NL16194.091.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Ipsen
Investigators  ICMJE
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
PRS Account Radboud University
Verification Date February 2009

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