Lanreotide as Treatment of Polycystic Livers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Polycystic Liver Disease Hepatomegaly Liver Diseases Polycystic Kidney, Autosomal Dominant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1

Lanreotide

Group Type EXPERIMENTAL

Lanreotide

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Lanreotide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No