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Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 90mg Every 4 Weeks in the Treatment of Symptomatic Polycystic Liver Disease, Including a Dose Escalation at Month 6 to Lanreotide Autogel 120mg for Non Responders

NCT01315795•Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Liver volume ≥ 4 liter
•≥ 20 liver cysts
•Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
•* Abdominal distention perceived as uncomfortable
•* Frequent abdominal pain
•* Early satiety
•* Nausea (with the inclusion of dyspeptic complaints)
•* Dyspnea
•Diagnosed with ADPKD or ADPLD
•Male and female patients of 18 years and older
+1 more criteria

Exclusion Criteria

•Creatinine clearance \< 20 ml/min
•Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
•Hormonal replacement therapy
•Hormonal contraception
•Pregnant or lactating
•Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
•Planned to undergo any surgery of the liver during study participation
•Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
•Patients with known allergies to somatostatin or its analogues or any of its components
•Patients who received somatostatin analogues in the 6 months preceding study inclusion

Locations (1)

UZ Leuven, Gasthuisberg

Leuven, Provincie Vlaams-Brabant, Belgium

Key Dates

Start Date

March 1, 2011

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

July 8, 2014

Enrollment

ACTUAL participants

Conditions

Polycystic Liver Disease

Interventions

Lanreotide Autogel 90 mg and 120 mg

DRUG

A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

NCT05478083

Polycystic Liver DiseaseAutosomal Dominant Polycystic Kidney

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UNKNOWN

The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease

NCT05215964

Polycystic Kidney DiseasesPolycystic Liver Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Inclusion Criteria

Exclusion Criteria

A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease

Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)