Lanreotide as Treatment of Polycystic Livers (LOCKCYST)

February 16, 2009 updated by: Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • University Hospital Gasthuisberg
  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Experimental: 1
Lanreotide
Drug: Lanreotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of total liver volume as determined by CT scan
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of liver volume and individual cyst volume on CT scan.
Time Frame: 6 months
6 months
Change of kidney volume and individual cyst volume on CT scan
Time Frame: 6 months
6 months
Symptom evaluation by (validated) questionnaires
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Ipsen

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Registration Dates

First Submitted

November 28, 2007

First Submitted That Met QC Criteria

November 28, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Estimate)

February 17, 2009

Last Update Submitted That Met QC Criteria

February 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMO 2007/010;ABR NL16194.091.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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