Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-31 @ 8:25 AM
Study NCT ID:
NCT01315795
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536330', 'term': 'Polycystic liver disease'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.', 'timeFrame': '6 months', 'description': 'Reduction of total liver volume after 6 months measured by means of CT-scan.'}, {'measure': 'Reduction of total liver volume after 12 months of treatment by means of CT-scan', 'timeFrame': '12 months', 'description': 'Reduction of total liver volume after 12 months of treatment by means of CT-scan'}, {'measure': 'Reduction of total liver volume after 18 months of treatment by means of CT-scan', 'timeFrame': '18 months', 'description': 'Reduction of total liver volume after 18 months of treatment by means of CT-scan'}], 'secondaryOutcomes': [{'measure': 'Measurement of total liver and kidney volumes and cyst volumes at baseline.', 'timeFrame': 'Baseline', 'description': '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.\n\n% 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'}, {'measure': 'Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan', 'timeFrame': '6 months', 'description': '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.\n\n% 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'}, {'measure': 'Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.', 'timeFrame': '12 months', 'description': '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.\n\n% 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'}, {'measure': 'Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan', 'timeFrame': '18 months', 'description': '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.\n\n% 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'}, {'measure': 'Assessment of quality of life at baseline', 'timeFrame': 'baseline', 'description': 'Assessment of quality of life at baseline'}, {'measure': 'Assessment of quality of life after 6 months of treatment', 'timeFrame': '6 months', 'description': 'Assessment of quality of life after 6 months of treatment'}, {'measure': 'Assessment of quality of life after 12 months of treatment', 'timeFrame': '12 months', 'description': 'Assessment of quality of life after 12 months of treatment'}, {'measure': 'Assessment of quality of life after 18 months of treatment', 'timeFrame': '18 months', 'description': 'Assessment of quality of life after 18 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['polycystic liver disease'], 'conditions': ['Polycystic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '19646443', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26073493', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/19646443', 'label': 'Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver volume ≥ 4 liter\n* ≥ 20 liver cysts\n* Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:\n\n * Abdominal distention perceived as uncomfortable\n * Frequent abdominal pain\n * Early satiety\n * Nausea (with the inclusion of dyspeptic complaints)\n * Dyspnea\n* Diagnosed with ADPKD or ADPLD\n* Male and female patients of 18 years and older\n* Written informed consent\n\nExclusion Criteria:\n\n* Creatinine clearance \\< 20 ml/min\n* Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year\n* Hormonal replacement therapy\n* Hormonal contraception\n* Pregnant or lactating\n* Presenting with an uncontrolled disease (other than ADPKD/ADPLD)\n* Planned to undergo any surgery of the liver during study participation\n* Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)\n* Patients with known allergies to somatostatin or its analogues or any of its components\n* Patients who received somatostatin analogues in the 6 months preceding study inclusion'}, 'identificationModule': {'nctId': 'NCT01315795', 'acronym': 'LOCKCYST', 'briefTitle': 'Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2010-024604-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symptomatic polycystic liver disease (PCLD) patients', 'description': 'Symptomatic polycystic liver disease (PCLD) patients', 'interventionNames': ['Drug: Lanreotide Autogel 90 mg and 120 mg']}], 'interventions': [{'name': 'Lanreotide Autogel 90 mg and 120 mg', 'type': 'DRUG', 'description': 'administration of lanreotide sc every 4 weeks (28 days)', 'armGroupLabels': ['Symptomatic polycystic liver disease (PCLD) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Provincie Vlaams-Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven, Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Frederik Nevens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven, Gasthuisberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr Frederik Nevens', 'investigatorFullName': 'Dr Frederik Temmerman', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}