A Phase 2/3 interventional study of Lanreotide Autogel 90 mg and 120 mg in Polycystic Liver Disease, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 2/3, Interventional, and Treatment
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.
118 studies on the registry are indexed under Cysts; 22 are open to participants now.
This study's enrollment of 59 is above the median of 51 across 72 interventional studies indexed under Cysts.
Browse Cysts studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
Exclusion Criteria:
Symptomatic polycystic liver disease (PCLD) patients
Drug: Lanreotide Autogel 90 mg and 120 mg
administration of lanreotide sc every 4 weeks (28 days)
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
Reduction of total liver volume after 6 months measured by means of CT-scan.
Time frame: 6 months
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Time frame: 12 months
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Time frame: 18 months
Measurement of total liver and kidney volumes and cyst volumes at baseline.
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group. % of patients with liver reduction \> 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Time frame: Baseline
Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group. % of patients with liver reduction \> 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Time frame: 6 months
Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group. % of patients with liver reduction \> 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Time frame: 12 months
Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan
Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group. % of patients with liver reduction \> 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months
Time frame: 18 months
Assessment of quality of life at baseline
Assessment of quality of life at baseline
Time frame: baseline
Assessment of quality of life after 6 months of treatment
Assessment of quality of life after 6 months of treatment
Time frame: 6 months
Assessment of quality of life after 12 months of treatment
Assessment of quality of life after 12 months of treatment
Time frame: 12 months
Assessment of quality of life after 18 months of treatment
Assessment of quality of life after 18 months of treatment
Time frame: 18 months
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven