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NCT00565097 Clinical Trial

Lanreotide as Treatment of Polycystic Livers

Liver Diseases Clinical Trial

— LOCKCYST  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00565097
Other study ID # CMO 2007/010;ABR NL16194.091.0
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 28, 2007
Last updated February 16, 2009
Start date October 2007

Study information
Verified date February 2009
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 88 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo

• Lanreotide

Locations
Country Name City State
Belgium University Hospital Gasthuisberg Leuven
Netherlands Radboud University Medical Center Nijmegen

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Ipsen

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of total liver volume as determined by CT scan 6 months
Secondary Reduction of liver volume and individual cyst volume on CT scan. 6 months
Secondary Change of kidney volume and individual cyst volume on CT scan 6 months
Secondary Symptom evaluation by (validated) questionnaires 6 months
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