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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic polycystic liver disease (PCLD) patients | Experimental | Symptomatic polycystic liver disease (PCLD) patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide Autogel 90 mg and 120 mg | Drug | administration of lanreotide sc every 4 weeks (28 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Diagnosed with ADPKD or ADPLD
Male and female patients of 18 years and older
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik Nevens, MD, PhD | UZ Leuven, Gasthuisberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven, Gasthuisberg | Leuven | Provincie Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19646443 | Result | van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. doi: 10.1053/j.gastro.2009.07.052. Epub 2009 Jul 29. | |
| 26073493 | Derived |
| Label | URL |
|---|---|
| Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. | View source |
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| ID | Term |
|---|---|
| C536330 | Polycystic liver disease |
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| 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 | 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 | 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 | 18 months |
| Assessment of quality of life at baseline | Assessment of quality of life at baseline | baseline |
| Assessment of quality of life after 6 months of treatment | Assessment of quality of life after 6 months of treatment | 6 months |
| Assessment of quality of life after 12 months of treatment | Assessment of quality of life after 12 months of treatment | 12 months |
| Assessment of quality of life after 18 months of treatment | Assessment of quality of life after 18 months of treatment | 18 months |
| Temmerman F, Ho TA, Vanslembrouck R, Coudyzer W, Billen J, Dobbels F, van Pelt J, Bammens B, Pirson Y, Nevens F. Lanreotide Reduces Liver Volume, But Might Not Improve Muscle Wasting or Weight Loss, in Patients With Symptomatic Polycystic Liver Disease. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2353-9.e1. doi: 10.1016/j.cgh.2015.05.039. Epub 2015 Jun 12. |