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NCT Number: NCT00565097

Lanreotide as 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.

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Key information

Conditions

Polycystic Liver Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hepatomegaly Hypertrophy Kidney Diseases Kidney Diseases, Cystic Liver Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Gasthuisberg, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Lanreotide

Drug

Primary outcomes

  1. Reduction of total liver volume as determined by CT scan

    Time frame: 6 months

Secondary outcomes

  1. Reduction of liver volume and individual cyst volume on CT scan.

    Time frame: 6 months

  2. Change of kidney volume and individual cyst volume on CT scan

    Time frame: 6 months

  3. Symptom evaluation by (validated) questionnaires

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Ipsen

Registry information

Official study title

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

Acronym: LOCKCYST

Important dates

Study start
2007
First posted
Nov 29, 2007
Registry last updated
Feb 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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