Lanreotide as Treatment of Polycystic Livers (LOCKCYST)

Radboud University Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Polycystic Liver Disease; Hepatomegaly; Polycystic Kidney, Autosomal Dominant; Liver Diseases

Treatments: Drug: Lanreotide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00565097

CMO 2007/010 ABR NL16194.091.0;

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

1

Experimental group

Description:

Lanreotide

Treatment:

Drug: Lanreotide