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Lanreotide as Treatment of Polycystic Livers (LOCKCYST)

Primary Purpose

Polycystic Liver Disease, Hepatomegaly, Liver Diseases

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Lanreotide
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Liver Disease focused on measuring Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney Disease, Liver cyst, Lanreotide

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Gasthuisberg
  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Placebo

Lanreotide

Outcomes

Primary Outcome Measures

Reduction of total liver volume as determined by CT scan

Secondary Outcome Measures

Reduction of liver volume and individual cyst volume on CT scan.
Change of kidney volume and individual cyst volume on CT scan
Symptom evaluation by (validated) questionnaires

Full Information

First Posted
November 28, 2007
Last Updated
February 16, 2009
Sponsor
Radboud University Medical Center
Collaborators
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00565097
Brief Title
Lanreotide as Treatment of Polycystic Livers
Acronym
LOCKCYST
Official Title
Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant
Keywords
Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney Disease, Liver cyst, Lanreotide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
1
Arm Type
Experimental
Arm Description
Lanreotide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Lanreotide
Primary Outcome Measure Information:
Title
Reduction of total liver volume as determined by CT scan
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction of liver volume and individual cyst volume on CT scan.
Time Frame
6 months
Title
Change of kidney volume and individual cyst volume on CT scan
Time Frame
6 months
Title
Symptom evaluation by (validated) questionnaires
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost PH Drenth, MD, PhD
Organizational Affiliation
Radboud University Medical Center Nijmegen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Loes van Keimpema, MSc
Organizational Affiliation
Radboud University Medical Center Nijmegen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederik Nevens, MD, PhD
Organizational Affiliation
University Hospital Gasthuisberg, University of Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

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Lanreotide as Treatment of Polycystic Livers

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